Source: http://www.csmdstratconsult.com/news-2019.html
Timestamp: 2019-12-12 10:52:43
Document Index: 249081499

Matched Legal Cases: ['art 23', 'Art. 50', 'art 809', 'art 2', 'art 1', 'art 4', 'art 5', 'art 807', 'art 801', 'art 820', 'art 803', 'Art. 6', 'Art. 6']

News 2019 - CS-MD STRAT&CONSULT
DECEMBER 4, 2019_EUROPE (EUROPEAN COMMISSION)
Publication of a series of documents concerning the UDI
MDR EUDAMED UDI Data Dictionary V5.0
GS1 Basic UDI-DI + GS1 UDI HRI & AIDC Formats
HIBCC Basic UDI-DI + HIBCC UDI HRI & AIDC Formats
ICCBBA Basic UDI-DI + ICCBBA UDI HRI & AIDC Formats
IFA Basic UDI-DI + IFA UDI HRI & AIDC Formats
DECEMBER 4, 2019_EUROPE (MEDTECH EUROPE)
Publication of 2 documents:
« Artificial Intelligence in Medical Technology: Delivering on the Promise of Better Healthcare in Europe »
​This 13-page document is a position paper by MedTech Europe that describes the challenges posed by artificial intelligence, and suggests ways to deal with them.​
​« Trustworthy Artificial Intelligence (AI) in healthcare »
​This 7-page publication represents MedTech Europe's contribution to the debate on ethics in artificial intelligence, and its response to the pilot phase of the "Ethics guidelines for trustworthy AI" initiative initiated by the European Commission in April 2019. from a document issued by a group of experts set up by the European Commission in June 2018.​
DECEMBER 4, 2019_SAUDI ARABIA (SFDA)
​SFDA have rolled out a single registration platform for all medical device market authorization, authorized representation and related applications to be submitted to the regulator.
The new system, Ghad, provides a single platform for submitting Medical Device Marketing Authorization (MDMA), Medical Device National Registry (MDNR), Saudi Authorized Representative and related applications to SFDA. Previously, Saudi Arabia market applicants had to utilize individual systems to submit MDMA, MDNR and other applications to Saudi regulators.
According to SFDA, Saudi medical device market registrants and in-country representatives face a December 26, 2019 deadline to open Ghad accounts and transfer both existing and in-process applications over to the new system. Following that deadline, any applications not yet migrated to Ghad will be cancelled.
DECEMBER 4, 2019_EUROPE (EUROPEAN PARLIAMENT)
MDR Second Corrigendum: Grace period for medical devices that are no longer self-certified
​On December 3rd, 2019 the European Parliament adopted the second corrigendum of the Medical Devices Regulation (EU) 2017/745 (MDR), with significant compliance deadline implications for some currently self-certified devices.
​Most of the corrections are relatively formal corrections in references or numbering. As mentioned in the draft version of the second corrigendum in late November, there is one correction that will have a significant impact on the implementation of the MDR: Article 120.3.
This change means that devices (not custom made devices) that are self-certified under the current Medical Devices Directive 93/42/EEC (MDD) will not have to be MDR certified from the Date of Application of the MDR (May 26th, 2020). They can rely on the Declaration of Conformity drawn up under the MDD until May 25th 2024. This will impact many self-certified devices:
DECEMBER 3,2019_FRANCE (CCAM)
CCAM Version 61
​La v61 de la CCAM permet la mise en œuvre au 1er janvier 2020 de la création d'un nouvel acte, d'un nouveau modificateur (Z) et de la modification de tarif de 16 actes.
DECEMBER 2, 2019_FRANCE (JORF)
Création de la Plateforme des Données de Santé » ou « Health Data Hub_Publication au JORF du 30/11/2019
​L’Institut National des Données de Santé (INDS), groupement d’intérêt public, est remplacé depuis le 30 novembre 2019 par la « Plateforme des Données de Santé », aussi appelée « Health Data Hub » dans les communications internationales. Cette plateforme est un des points forts de la stratégie Intelligence Artificielle française.
NOVEMBER 28, 2019_EUROPE (CAMD)
EUDAMED State Of Play : Open Letter From The CAMD Executive Group
​Following the public announcement by the European Commission of the postponement of EUDAMED’s launch until May 2022, the CAMD Executive group has prepared an open letter to share its concerns about this development.
The CAMD Executive group emphasises the need for the application of the new Regulation and on the continued significant commitment needed by all stakeholders to this.
The CAMD Executive offers to Commission and MDCG its support to find proper and practicable solutions for the short, medium and long term.
nOVEMBER 26, 2019_EUROPE (COUNCIL OF THE EUROPEAN COMMISSION)
Publication of a second corrigendum draft to the Regulation 2017/745
​Manufacturers of class I (upclassified / reusable instruments) have a delay extension of 4 years to obtain a MDR CE certificate from Notified Bodies => May 2024.
​English Version (pg. 44-50) German Version (pg. 26-31) French Version (pg. 50-55)
The corrigendum needs to be adopted by the European Parliament to take effect.
NOVEMBER 22, 2019_CNEDiMTS (FRANCE)
Dispositifs médicaux financés dans les tarifs des prestations d’hospitalisation (INTRA-GHS)
​Guide pour le dépôt d’un dossier auprès de la Commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS) - Novembre 2019
NOVEMBER 20, 2019_MFDS (SOUTH KOREA)
Reduction of submission requirements for high-risk medical devices
According to a notification (link in Korean) from the regulator, manufacturers of Class IV devices will no longer be required to prepare and submit full Summary Technical Documentation (STED) files along with Korean technical files when applying for South Korean market authorization.
In lieu of full STED files, MFDS will require the following STED-related documentation from Class IV device market applicants:
Flow charts showing each step of the device’s manufacturing process;
Detailed explanations of processes that could affect the performance and/or effectiveness of the device;
Descriptions and indications of all sterilization methods, standards, validation cycles and conditions utilized in the device’s manufacturing process.
The MFDS announcement is expected to reduce submission preparation timeframes for Class IV device applicants, potentially easing South Korean market entry for higher-risk device manufacturers.
November 8, 2019_IMDRF (INTERNATIONAL)
Publication of 3 final documents
WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Investigation http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n57.pdf
WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007) Clinical evaluation http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n56.pdf
WG/N55 FINAL:2019 (formerly GHTF/SG5/N1R8:2007) Clinical Evidence - Key Definitions and concepts http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-191010-mdce-n55.pdf
NOVEMBER 6, 2019_FRANCE (HAS-CNEDiMTS)
- Mise à jour du guide : https://www.has-sante.fr/upload/docs/application/pdf/2016-01/guide_fabricant_2016_01_11_cnedimts_vd.pdf
- Mise à jour de la matrice du dossier de dépôt à destination du fabricant : Matrice du dossier de dépôt destiné au fabricant (mise à jour octobre 2019)
NOVEMBRE 4, 2019_FRANCE (CEPS)
Plateforme de dépôt des dossiers auprès du CEPS effective au 1er Janvier 2020
Le Comité économique des produits de santé a révisé ses procédures afin notamment de préparer l'arrivée d'une plateforme de dépôt des dossiers relatifs aux dispositifs médicaux (DM) et aux prestations au 1er janvier 2020 MedimedDM
Guide pratique des procédures à suivre dans le cadre de la prise en charge des dispositifs médicaux sur la liste des produits et prestations remboursables définie à l’article L. 165 1 du code de la sécurité sociale (LPP): https://solidarites-sante.gouv.fr/IMG/pdf/guide_pratique_depot_dossiers_dm.pdf
Guide d’utilisation du portail MedimedDM : https://solidarites-sante.gouv.fr/IMG/pdf/guide_medimeddm_utilisateur_version_oct_2019-2.pdf
october 31, 2019_MALAYSIA (MDA)
Malaysia’s Medical Device Authority in October revised its requirements for the labeling of medical devices. Under the new guidelines, devices must be labeled with a Malaysian medical device registration number within six months from their date of registration.
Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices must be labeled in English.
​Label contents must be submitted to the Medical Device Authority as part of the device registration process.
OCTOBER 30, 2019_EUROPE (EUROPEAN COMMISSION)
The date of application of the MDR remains May 2020.
October 17, 2019_EUROPE (EUROPEAN COMMISSION)
Documents MDCG
​https://ec.europa.eu/docsroom/documents/37688
MDCG 2019-12 Designating authority's final assessment form: Key Information (EN)
​https://ec.europa.eu/docsroom/documents/37689?locale=en
OCTOBER 15, 2019_EUROPE (EUROPEAN COMMISSION)
List of national market surveillance authorities (MSA)
- By sector: https://ec.europa.eu/docsroom/documents/37623?locale=en
- By country: https://ec.europa.eu/docsroom/documents/37622?locale=en
OctobeR 11, 2019_EUROPE (EUROPEAN COMMISSION)
MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR
This document, which primarily targets medical software manufacturers, defines the criteria for the qualification of software falling within the scope of the new medical devices regulations and provides guidance on the application of classification criteria for software under Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.
The guidance also provides information related to placing on the market. The classification criteria (classification rules) are set out in Annex VIII of the Medical Devices Regulation (EU) 2017/745 (MDR) and Annex VIII of the In vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR).
OCTOBER 8, 2019_EUROPE (SNITEM)
Poster, l'Identifiant Unique du Dispositif (IUD) en pratique
A l'occasion d'Europharmat 2019, le Snitem revient sur les applications de l'identifiant unique du dispositif (IUD).
Comment l'IUD est-il structuré, quelles sont ses bases, quels sont les différents standards admis ?
OCTOBER 7, 2019_EUROPE (SNITEM/EUROPHARMAT)
Guide sur l'application du règlement (UE) 2017/745 relatif aux dispositifs médicaux à destination des établissements de santé
Le Snitem et Europharmat ont travaillé ensemble sur un guide évolutif qui recense les principales conséquences du règlement 2017/745 au sein des établissements de santé.
Formulé sous formes de questions/réponses, ce guide répond à un besoin d'information spécifique des pharmaciens hospitaliers et apporte des éléments de compréhension du règlement afin de prévenir les situations de blocage et de ruptures de stocks.
OCTOBER 3, 2019_BRAZIL (ANVISA)
Approval of formal regulations for custom-made medical devices
​RDC 305/2019 defines “custom-made device” as any device intended for use by a specific patient or user, and that has been manufactured for that patient or user based on a healthcare provider’s prescription that includes specific device design features. Besides standard Brazilian market registration requirements, custom-made devices must also undergo the following process:
For all classes of custom-made devices, manufacturers and importers must first submit to ANVISA a Request for Consent to manufacture and/or import a custom-made device based on a specific manufacturing plan.
Second, firms must submit a Request for Consent to notify Brazilian regulators of the manufacture and/or importing of each particular custom-mad device.
Manufacturers and importers of Class III and Class IV custom-made devices must implement and maintain Brazilian Good Manufacturing Practice (BGMP) quality management system certification for production sites, or have renewal protocols appropriate to their devices’ risk classifications.
​​ANVISA identifies several documentation and process requirements manufacturers and importers of devices under the scope of RDC 305/2019 should also meet:
Labeling requirements, including traceability data for implantable devices and package label information
Record keeping timelines (15 years for implantable devices and five years for non-implantable products)
Post-market requirements according to RDC 67/2009 and RDC 23/2012
BGMP compliance for Class I and Class II devices
Safety and effectiveness compliance requirements under RDC 56/2001
OCTOBER 2, 2019_INTERNATIONAL (IMDRF)
IMDRF Principles and Practices for Medical Device Cybersecurity
This consultation closes on Monday, 2 December 2019.
This document is designed to provide concrete recommendations to all responsible stakeholders on the general principles and best practices for MD cybersecurity (including in vitro diagnostic (IVD) medical devices). In general, it outlines recommendations for MD manufacturers, healthcare providers, regulators, and users to: employ a risk-based approach to the design and development of medical devices with appropriate cybersecurity protections; minimize risks that could arise from use of the device for its intended purposes; and to ensure maintenance and continuity of critical device safety and effectiveness.
​This document considers cybersecurity in the context of MDs that: 1) contain software, including firmware and programmable logic controllers (e.g. pacemakers, infusion pumps); and 2) exist as software only (e.g. Software as a Medical device (SaMD)). It is important to note that the scope of this MD cybersecurity guidance is limited to consideration of the potential for patient harm. While other types of harms such as those associated with breaches of data privacy are important, they are not considered within the scope of this document.
SEPTEMBER 30, 2019_USA (FDA)
Metals and metal alloys are commonly used in implanted medical devices and in inserts like amalgam dental fillings, and these materials are sometimes in contact with parts of the body for extended periods of time. Part of the FDA's evaluation to determine whether a medical device is safe and effective involves reviewing information about metals and other materials used in the device.​
Concerns About Immune Responses to Metal in Medical Devices
Metal-Containing Implants
Determining Medical Device Material Safety
More FDA Information on Metals in Medical Devices
SEPTEMBER 30, 2019_EUROPE (EUROPEAN COMMISSION)
New MIR form - as from January 2020
New manufacturer incident report for importing XML file with Adobe Professional
New manufacturer incident report XSD files (for implementation in manufacturer’ databases)
Device specific vigilance guidance
DSVG 03 Cardiac implantable electronic devices (CIED)
DSVG 04 Breast implants
SEPTEMBER 28, 2019_FRANCE (CCAM)
Classification Commune des Actes Médicaux_Publication de la version 60
La v60 de la CCAM permet la mise en œuvre au 18 octobre 2019 de la création d'actes, d'ajout de note de facturation pour le modificateur M, de modification de code regroupement notamment.
https://www.ameli.fr/fileadmin/user_upload/documents/CCAM_V60.pdf
SEPTEMBER 27, 2019_USA (FDA)
Guidances with Digital Health Content​
The guidance documents listed here are FDA guidances with Digital Health content and are intended to provide clarity on the FDA's regulation of digital health products.​
Draft Clinical Decision Support Software
SEPTEMBER 26, 2019_EUROPE (EUROPEAN COMMISSION)
MDCG 2019-9 Summary of safety and clinical performance - A guide for manufacturers and notified bodies
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP.
​Template for the SSCP in appendix of the document.
SEPTEMBER 26, 2019_USA (FDA)
Draft Guidance "Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act"
Comments to be submitted by 11/25/2019
This document provides guidance on FDA's interpretation of the statutory requirement for submission in electronic format; however, this document also contains guidance on additional submission types for which submission in electronic format is anticipated to be recommended.
SEPTEMBER 20, 2019_USA (FDA)
Guidance "Safety and Performance Based Pathway"
The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well understood device types.
What device types are appropriate for the Safety and Performance Pathway
Draft guidance providing performance criteria in support of the Safety and Performance Based Pathway available for:
- cutaneous electrodes for recording purpose https://www.fda.gov/media/130864/download
- Orthopedic Non-Spinal Metallic Bone Screws and Washers https://www.fda.gov/media/130866/download
- Spinal Plating Systems https://www.fda.gov/media/130867/download
Comments to be submitted by 12/19/2019
SEPTEMBER 17, 2019_AUSTRALIA (TGA)
Essential principles checklist updated
It is the manufacturer's responsibility to demonstrate compliance with the essential principles for their medical devices.
SEPTEMBER 13, 2019_FDA (USA)
4 guidances issued by the FDA
​https://www.fda.gov/media/130647/download
This document supplements other FDA guidance documents regarding the content for a 510(k) submission.
https://www.fda.gov/media/72646/download​
The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum thresholdof acceptability and should be accepted for substantive review.
​This guidance provides the FDA current thinking on premarket notifications (510(k)s) appropriate for review as a Special 510(k).
The intent of this guidance is to describe an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device, and design control procedures produce reliable results that can form, in addition to other 510(k) content requirements, the basis for substantial equivalence (SE).
SEPTEMBER 12,2019_EUROPE (SCHEER)
"Annex I Chapter II Section 10.4.1 of the Regulation (EU) 2017/745 states that substances that are carcinogenic, mutagenic, or reprotoxic (CMR) of category 1A and 1B, or substances having endocrine-disrupting (ED) properties for which there is scientific evidence of probable serious effects on humans, shall only be present in devices, or parts thereof or those materials used therein, above 0.1% weight by weight (w/w) when justified according to a set of criteria listed under Section 10.4.2. These Guidelines describe the methodology on how to perform a BRA for the justification of the presence of CMR 1A or 1B and/or ED phthalates (CMR/ED phthalates) in medical devices at percentages above 0.1% by weight (w/w). They also describe the evaluation of possible alternatives for these phthalates used in medical devices, including alternative materials, designs or medical treatments."
SEPTEMBER 9, 2019_FDA (USA)
Guidance Acceptance Review for De Novo Classification Requests
The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic class III designation (De Novo classification request or De Novo request) meets a minimum threshold of acceptability and should be accepted for substantive review.
2 related documents published:
· the different FDA actions that may be taken on De Novo requests;
· the effect each action has on goals under MDUFA IV for De Novo requests received in FY 2018-2022; and
· the different industry actions that may be taken on De Novo requests.
https://www.fda.gov/media/107652/download
User Fees and Refunds for De Novo Classification Requests​
​​https://www.fda.gov/media/107658/download
SEPTEMBER 4, 2019_SAUDI ARABIA (SFDA)
MDMA fee increases, new regulations in the works​
​​According to updated guidance issued by the Saudi Food and Drug Authority (SFDA), the fee increase for Medical Device Marketing Authorization (MDMA) is set to take effect October 1, 2019, followed by implementation of a new regulatory system in early 2020. If implemented as planned, the new fees would mean an increase of between roughly USD $3,000 to $8,000 per application.​ The new fees will be based on the number of devices and/or accessories included in an MDMA application, whereas currently fees are assessed according to device risk class as well as leveraged reference market.
The updated guidance also indicates that the Saudi government plans to go through with establishing a new regulatory system for medical devices as early as January 2020. The new SFDA requirements will include a new risk classification system for devices, which may result in manufacturers no longer being able to leverage reference markets such as the European Union or US to obtain registration in Saudi Arabia.
Finally, SFDA has set a 60-calendar-day deadline for MDMA applicants to respond to inquiries from the regulator or from Conformity Assessment Bodies. Applicants needing additional time to address issues should provide justifications to SFDA. Otherwise, failure to meet the 60-day deadline will result in SFDA deleting the MDMA application in question. This new deadline may reduce overall SFDA review and approval timeframes for MDMA applicants, although some companies will be challenged to meet these requirements.
SEPTEMBER 4, 2019_AUSTRALIA (TGA)
2 documents released for consultation ​
Proposed changes to the medical device Essential Principles for safety and performance_Version 1.0, September 2019
https://www.tga.gov.au/sites/default/files/consultation-proposed-changes-medical-device-essential-principles-safety-and-performance.pdf
Proposed clarification of the regulatory requirements for medical device systems and procedure packs V1.0 September 2019
​https://www.tga.gov.au/sites/default/files/consultation-proposed-clarification-regulatory-requirements-medical-device-systems-and-procedure-packs.pdf
SEPTEMBER 3, 2019_MEXICO (COFEPRIS)
​The Mexican government will begin requiring electronic submission of all import permit applications starting September 24, 2019.
According to new rules now published (link in Spanish) in Mexico’s Official Federal Journal, medical device manufacturers and their representatives seeking import permits necessary for commercial purposes, donations, personal use and other reasons will have to submit permit applications via VUCEM, the government’s online platform for digitally monitoring imports and exports to and from the country.
AUGUST 30, 2019_EUROPE (BSI)
White paper "Risk management for medical devices and the new ISO 14971"
​Discussion of the development of risk management over the past centuries; the risk management process as described in ISO 14971, including a discussion of the main changes in the third edition, which is expected to be published in 2019; and the broader context of ISO 14971 and its use in conjunction with other international standards to demonstrate compliance with regulatory requirements.
auGUST 30, 2019_USA (FDA)
Publication of 2 guidances
This guidance enhances transparency and consistency in the premarket review process by describing several factors that FDA considers in assessing the appropriate extent of uncertainty about a device’s benefits and risks when reviewing these types of premarket submissions. Further, this guidance provides illustrative examples based on current practice of how the principles for considering uncertainty could be applied in the context of clinical evidence and when greater uncertainty could be appropriate in the PMA context, such as PMAs for Breakthrough Devices and PMAs for devices intended for small patient populations. However, these examples are not intended to imply that FDA’s consideration of uncertainty in premarket benefit-risk determinations is limited to these scenarios.
https://www.fda.gov/media/115672/download
This guidance document explains the principal factors that FDA considers when making benefit-risk determinations in the premarket review of certain medical devices. The processes discussed in this guidance are applicable to devices subject to premarket approval (PMA) applications or De Novo classification requests. This guidance applies to both diagnostic and therapeutic devices. The concepts discussed in this guidance are applicable to the medical device development process from design to market. As such, the benefit-risk factors set out herein should be considered during the design, non-clinical testing, Pre-Submission, and Investigational Device Exemption (IDE) phases as well as in assembling and assessing PMA applications or De Novo requests. Although guidance isnot binding, the concepts and factors described herein generally explain how benefit-risk determinations are made by FDA during the premarket review process. The intersection of this Guidance with ISO 14971 is discussed in Appendix A.
https://www.fda.gov/media/99769/download
AUGUST 29, 2019_CHINA (NMPA)
Chinese NMPA publishes UDI system rules for medical device registrants​
​The National Medical Products Administration (NMPA), China’s medical device market regulator, has published official Unique Device Identification (UDI) requirements that will take effect October 1, 2019.
​According to NMPA, the new rules lay out UDI responsibilities both for manufacturers as well as code agencies that will issue UDI labels for devices. UDIs in China will include product identification unique to particular devices as well as production identification data such as serial and batch numbers, production dates and manufacturing process information.
NMPA’s UDI implementation roadmapManufacturers that are either applying for Chinese market access or submitting modifications to their existing NMPA registrations must take the following steps:
AUGUST 26, 2019_FRANCE (LPP)
Lignes génériques: arrêté du 26 août modifiant l'arrêté du 24 juin 2019​
Un nouvel arrêté concernant les lignes génériques pour lesquelles la codification unique s'impose aux fabricants en vue de leur remboursement vient d'être publié.
Il corrige des erreurs apparues sur la liste présentée dans le premier arrêté du 24 juin 2019.
august 23, 2O19_FRANCE (EUROPHARMAT)
Codage individuel des dispositifs médicaux inscrits sur la LPP en description générique
La disposition prévue par la loi de financement de la sécurité sociale pour 2017 est en cours de déploiement.
Un petit mémo vous est proposé pour mieux appréhender les incidences pour les personnes dispensant ces DM (PUI & secteur communautaire), sachant que le SNITEM en a réalisé un à destination des fabricants.
Ce document viendra prochainement amender le Guide la LPPR pour les débutants.
AUGUST 23, 2019_AUSTRALIA (TGA)
Medical Device Incident Reporting (MDIR) guide_Sponsor guide to MDIR 2019 Version 2.0, August 2019
This document is a user guide for sponsors in regard to the MDIR system. It outlines the initial steps to access the MDIR system and then describes how to use the system, with step by step instructions and examples as required.
The MDIR system has been enhanced to enable sponsors and manufacturers to monitor and track device incident reports. You will be able to lodge reports electronically, update previously reported incidents with additional information, review the status of reports, update initial and follow-up reports, and view past reports. All submitted reports and updates are received immediately by the Therapeutic Goods Administration (TGA).
AUGUST 22, 2019_HONG-KONG (MDCO)
Expedited medical device registration pilot program
​On August 20, Hong Kong’s Medical Device Control Office (MDCO) posted information about a pilot program for the expedited review for Class II, III and IV medical device listing applications. Qualified applications will be accepted from this September 1st to June 30th of next year. The expedited review is expected to shorten the target review time to 8 weeks.
AUGUST 20, 2019_FRANCE (JORF)
Il prévoit que les produits marqués CE éligibles à la LPPR et destinés à traiter une maladie grave ou rare, en l'absence d'alternative de traitement et présentant une efficacité cliniquement pertinente, soient pris en charge de façon précoce et transitoire sous 90 jours.
AUGUST 8, 2019_INTERNATIONAL (IMDRF)
Requirements for Regulatory Authority Recognition of Conformity Assessment Bodies Conducting Medical Device Regulatory Reviews
​A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Good Regulatory Review Practices Working Group is provided for public comment.
This consultation closes on Thursday, 3 October 2019.
​The purpose of this document is to define the requirements for CABs performing regulatory reviews and other related functions for medical devices, including IVD medical devices. Both the regulatory review process and the decisions made by a CAB may be subject to further review by the applicable Regulatory Authority in the countries and regions where the medical device is manufactured and/or placed on the market.
AUGUST 7, 2019_AUSTRALIA (TGA)
Medical device patient information leaflets and implant cards​
Guidance Requirements for new and on-market implantable medical devices_Version 1.1, August 2019
​​​The purpose of this guidance is to help manufacturers and sponsors understand how the TGA interprets regulations, and thus indicate how a manufacturer and/or sponsor can comply. This is a guide only, and manufacturers and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each manufacturer or sponsor to understand and comply with these requirements.
Best practice for Patient Information Leaflets and Patient Implant Cards
In addition to the legislated requirements, there are other features of leaflet and card design that can be very helpful for patients. This information is not mandatory, but is included to further improve the way this information is provided.
​www.tga.gov.au/best-practice-patient-information-leaflets-and-patient-implant-cards
AUGUST 1, 2019_USA (FDA)
Draft guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment
This draft guidance document provides Food and Drug Administration’s recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling. Submit Comments by 10/01/2019
JULY 31, 2019_USA (FDA)
​The 510(k) Third Party Review Program provides medical device manufacturers with an alternative review process, in which accredited Third Party Review Organizations (Review Organizations) are allowed to review certain low-to-moderate risk medical devices. The program is intended to help yield more rapid 510(k) decisions and to allow the FDA to focus its resources on higher risk devices, while still maintaining oversight of the review of lower risk devices eligible for third party review. This program is formally known as the Accredited Persons Program.
JULY 30, 2019_UK (MHRA)
july 29, 2019_USA (FDA)
​The US Food and Drug Administration has added a new standard developed by AAMI, ANSI and UL for safety of interoperable medical devices to its list of recognized consensus standards, providing a tool for manufacturers of interoperable products to demonstrate safety as well as cybersecurity risk management.
JULY 29, 2019_FRANCE (CCAM)
Classification Commune des Actes Médicaux_Publication de la version 59
La version 59 de la CCAM permet la mise en œuvre au 1er septembre 2019 de la modification de tarifs pour 9 actes.
www.ameli.fr/fileadmin/user_upload/documents/CCAM_V59.pdf
JULY 26, 2019_INDIA (CDSCO)
India compliance maintenance : Notified body change
​​Given recent conditions of Brexit, many companies are impacted with changes regarding their notified body. This change ultimately changes the CE Mark on labeling, thus requiring amendments to any existing Import Licenses in India.
JULY 26, 2019_HEALTH CANADA
Medical Device Licence Application Fee Form
JULY 26, 2019_AUSTRALIA (TGA)
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)_Version 1.3
JULY 25, 2019_UK (MHRA)
​Contingency legislation is needed in order for the Medicines and Healthcare products Regulatory Agency (MHRA) to be able to take on regulatory processes for human medicines and devices that are currently undertaken by the European Medicines Agency and other bodies.
JULY 24, 2019_BRAZIL (ANVISA)
​Brazilian medical device market regulator ANVISA has begun requiring manufacturers and sponsors to provide field safety corrective action information via an electronic petitioning system.
According to an ANVISA announcement, companies whose medical devices or IVDs are involved in adverse events or other incidents must now submit FSCAs through the agency’s online system, Sistema Solicita (links in Portuguese). ANVISA is no longer accepting hard copies or email submissions.
JULY 23,2019_EUROPE (EUROPEAN COMMISSION)
Implementing regulation: Single-use medical devices - safety and performance requirements for reprocessing
​The Commission would like to receive comments on this implementing act.
​Feedback period
23 July 2019 - 20 August 2019
JULY 18, 2019_AUSTRALIA (TGA)
​This guidance is for manufacturers and sponsors of medical devices that include software or electronic components.
manufacturers that develop software for use in or as standalone medical devices, such as in Software as a Medical Device (SaMD); this includes devices that incorporate artificial intelligence in their design
manufacturers of medical devices (including in-vitro diagnostic medical devices) where devices include components that may be vulnerable to cyber-based threats
medical device sponsors who are responsible for the supply of medical devices in Australia, to ensure that safety and quality is demonstrated and compliance with the Essential Principles is maintained.
Information are available for users and consumers:​
Medical device cyber security information for users
Guidance for consumers, health professionals, small business operators and large scale service providers
july 15, 2019_USA (FDA)
Ethylene Oxide Sterilization for Medical Devices_FDA innovation challenges
​Identify Sterilization Alternatives
​Read more about Challenge 1: Identify New Sterilization Methods and Technologies
Reduce Ethylene Oxide Emissions
​Read more about Challenge 2: Reduce Ethylene Oxide Emissions
JULY 15, 2019_AUSTRALIA (TGA)
Webinar presentation: Proposed Reforms to the Regulation of Software, Including Software as a Medical Device - Consultation Results
Presented by: Dr Elizabeth McGrath
Presented at: Digital Devices Webinar 3
Presentation date: 20 June 2019
july 11, 2019_USA (FDA)
Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials Guidance for Institutional Review Boards, Industry, Clinical Investigators, and Food and Drug Administration Staff
The purpose of this document is to provide Institutional Review Boards (IRBs), industry, clinical investigators, and Food and Drug Administration (FDA) staff factors to consider when evaluating the appropriateness of a live case presentation within a clinical investigation conducted under an investigational device exemption (IDE) application. This document provides guidance on important information about a live case presentation that should be provided as part of an original IDE application or a supplement to an IDE application when requesting inclusion of a live case presentation during a clinical investigation. Applications and supplements that include a live case presentation are referred to generally as “requests” throughout this document.
JULY 10, 2019_EUROPE (EUROPEAN COMMISSION)
Introduces a new Manufacturer’s Incident Report and the new template for Field Safety Notice.
The document also highlights that the most recent revision of all of the forms that currently support the Medical Device Vigilance System can now be found on the EU commission website rather the Annexes of the MEDDEV 2.12-1 rev. 8, 2013.
JULY 10, 2019_INTERNATIONAL (IMDRF)
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G
​A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Medical Device Adverse Event Terminology Working Group is provided below for public comment.
This consultation closes on Tuesday 10 September 2019.
This document has been prepared by the IMDRF Adverse Event Working Group, charged with developing a harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs).
JULY 9, 2019_EUROPE (SNITEM)
Recherche clinique et DM
Mise à disposition par le SNITEM d'une fiche mnémotechnique consacrées aux recherches cliniques dans le dispositif médical.
Quelles sont les catégories de recherches cliniques dans le dispositif médical ? Comment sont-elles mises en place, contrôlées et suivies ? Quels changements induit le règlement européen ?
JULY 8, 2019_CHINA (nmpa)
China – Chinese NMPA update: eRPS, predicate device data, technical review guidelines
JULY 4, 2019_FRANCE (ANSM)
Application du règlement européen relatif aux dispositifs médicaux : l’ANSM met en place une phase pilote pour la partie investigations cliniques - Point d'information
La phase pilote, qui sera lancée le 16 septembre 2019, va permettre de simuler la nouvelle organisation imposée par le règlement UE n° 2017/745, notamment concernant les délais d’évaluation des dossiers et l’organisation de la coordination entre l’ANSM et les 39 CPP existants, tout en respectant la réglementation actuelle. La France est le premier pays européen à lancer une phase pilote.
JULY 4, 2019_FRANCE (CCAM)
Classification Commune des Actes Médicaux_Publication de la version 58
La CCAM v58 permet la mise en œuvre au 14/07/2019 : création de 19 actes et d’associations, suppression de 6 actes, modification de libellés, ajout de notes. Elle corrige au 14/07/2019 la cat. Médicale et l’ajout du code exo TM7 pour l’acte HBFD010, des dates de fin d’actes.
​www.ameli.fr/fileadmin/user_upload/documents/CCAM_V58.pdf​
JULY 3, 2019_australia (TGA)
Advertising health products: Rules about safety claims in advertising​
​The Therapeutic Goods Advertising Code (No.2) 2018 prevents advertisers from claiming that therapeutic goods (including medicines and medical devices) are safe, that their use cannot cause harm, or that they have no side-effects.
​Safety claims in advertising may be explicit or implicit - both are prohibited
JULY 2, 2019_AUSTRALIA (TGA)
The 2019-20 fees and charges schedule applies to applications submitted to the TGA on or after 1 July 2019.
JULY 1, 2019_USA (FDA)
Center for Devices and Radiological Health (CDRH) Appeals Processes Guidance for Industry and Food and Drug Administration Staff
This guidance document describes the processes available to outside stakeholders to request additional review of decisions or actions by Center for Devices and Radiological Health (CDRH or the Center) employees.
The Food and Drug Administration also published "Appeals Processes: Questions and Answers About 517A"
​www.fda.gov/media/128447/download﻿
JULY 1, 2019_EUROPE (EUROPEAN COMMISSION)
Publication of 2 new documents:
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding a ‘person responsible for regulatory compliance’ (PRRC)
MDCG 2019-8 Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
This document provides guidance for Member States, concerned industry and other stakeholders on a blueprint of an implant card (IC) required by the MDR (Regulation (EU) 2017/745). It describes the intended use, content and information to be provided by the manufacturer together on the IC and a definition of fields to be completed by the implanting healthcare institutions or healthcare providers according to national law in Member States. Whereas the intended purpose and most of the data elements of the IC are already defined in Article 18 of the MDR, this document contains the description of other data elements which must be completed by the healthcare institution or healthcare provider and which must be considered by the individual Member State when implementing Article 18 MDR as required
JUNE 28, 2019_AUSTRALIA (TGA)
The application process has now changed from a PDF manual entry form to an online application form. A guidance is available to assist advertisers with preparing and submitting an application for approval to use a restricted representation in advertising:
www.tga.gov.au/guidance-submitting-application-approval-use-restricted-representation
JUNE 27, 2019_FRANCE (LPP)
Liste des codes LPP (descriptions génériques) nécessitant un code d’identification individuel
En application de l’article R. 165-87 du code de la sécurité sociale, l’annexe au présent arrêté fixe la liste des descriptions génériques pour lesquelles le code d’identification individuelle du produit ou de la prestation prévu à l’article L. 165-5-1 du même code doit être détenu par le fabricant. Par défaut, s’agissant des autres descriptions génériques remboursables non mentionnées dans ladite annexe, le code d’identification individuelle du produit ou de la prestation doit être détenu par le distributeur.
Rappel : Voir Décret no 2019-571 du 11 juin 2019 publiée au JORF du 12 juin 2019 pour les dates obligatoires (attention codes à demander 4 mois avant la date). La demande de code est effectuée par voie dématérialisée, en utilisant un formulaire accessible depuis le site internet du ministère chargé de la santé et de la sécurité sociale. Le site précise la procédure à suivre par l’entreprise en vue de l’obtention du code.
﻿​www.legifrance.gouv.fr/jo_pdf.do?id=JORFTEXT000038578527
JUNE 26, 2019_EUROPE (EUROPEAN COMMISSION)
ANNEX I: List of existing standards to be revised and list of new standards to be drafted in support of Regulation (EU) 2017/745 as referred to in Article 1(1)
ANNEX II: List of existing standards to be revised and list of new standards to be drafted in support of Regulation (EU) 2017/746 as referred to in Article 1(2)
=> lists specifying the Deadline for the adoption by the European Standardisation Organisations = May 27, 2024
JUNE 26, 2019_HEALTH CANADA
Guidance Document: Pre-market Requirements for Medical Device Cybersecurity
This guidance document is intended to provide advice to manufacturers and regulatory representatives on the practices, responses and mitigation measures, which can improve the cybersecurity of their medical device.
Reporting requirements of serious adverse drug reactions and medical device incidents for hospitals.
Regulatory requirements for hospitals
Which hospitals must report
JUNE 24, 2019_MALAYSIA (MDA)
Foreign manufacturers entering the Malaysian market will be able to leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States).
The chart demonstrates the route to compliance in Malaysia for devices that have already obtained approval in a reference market. Recognized reference markets include: Australia, Canada, European Union countries, Japan, and the United States. This is not a requirement and an approval process does exist for imported devices with no reference market approval; however, the process in Malaysia will be eased by already having such approvals.
JUNE 21, 2019_EUROPE (EUROPEAN COMMISSION)
Expert panels will respond to consultations on novel high-risk devices before they are certified for the EU single market. The experts will also be involved in other tasks such as contributing to the development of common specifications for clinical evaluation of device categories, guidance documents or standards.
JUNE 21, 2019_USA (FDA)
​Expanded access is a potential pathway for patients with a serious or life-threatening disease or condition to access an investigational medical device that has not been approved or cleared by the FDA for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available through one of three mechanisms:
Compassionate Use (or Individual Patient/Small Group Access)
Treatment Investigational Device Exemption (IDE)
JUNE 21, 2019_AUSTRALIA (TGA)
Cost recovery implementation statement 2019-2020
The cost recovery implementation statement outlines the TGA's regulatory costs and provides detailed information on TGA's cost recovery arrangements.
The CRIS has been updated to reflect the revised fees and charges which were approved by the Executive Council on 21 March 2019, commencing from 1 July 2019.
June 19, 2019_AUSTRALIA (TGA)
Guidance on Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019
​This is a legislative instrument made by a delegate of the Minister for Health under section 41DC of the Act. The Order constitutes a conformity assessment standard for the quality management systems identified in the Order.
​The effect of the Order is to provide an alternative means for manufacturers of medical devices to demonstrate that they have applied those parts of the conformity assessment procedures that relate to implementing and maintaining a QMS in relation to its manufacture of medical devices.
The Order does this by reference to a number of standards published by the International Organisation for Standardization (“the ISO”).
The Order has the effect that if a manufacturer’s QMS complies with the standard specified in the Order, it will be treated as having had applied to it those parts of the conformity assessment procedures specified in the Order.
JUNE 18, 2019_EUROPE
Another Notified Body Bows Out Ahead of EU MDR
​Swiss notified body (NB) QS Zürich AG has decided that it will not pursue designation under the new EU medical devices regulation (MDR), although EN ISO 13485 support will remain.
JUNE 18, 2019_HEALTHCANADA
​Health Canada on Friday launched a public consultation soliciting feedback on a set of proposed regulations intended to provide the agency with better safety information for marketed Class II, III and IV medical devices.
www.gazette.gc.ca/rp-pr/p1/2019/2019-06-15/html/reg7-eng.html
JUNE 18, 2019_BRAZIL (ANVISA)
Step One: Class III and IV custom-made devices must request BGMP quality system inspections; Class I and II devices do not have to submit such requests.
Step Two: Manufacturers of all classes of custom-made devices must submit Requests for Consent to manufacturer or import such a device per a manufacturing plan.
Step Three: Manufacturers of Class III and IV devices must submit Requests for Consent to notify ANVISA of the manufacturing or importing of each individual custom-made device they have produced. This requirement is not applicable to Class I and II device manufacturers.
Adaptable medical devices: mass-produced devices that undergo adaption, adjustment, fitting or molding based on a manufacturer’s instructions at the point of care to address a patient’s particular anatomic and physiological characteristics before use.
Adaptable medical devices must undergo ANVISA registration.
Patient-specific medical devices: devices made compatible to a patient’s anatomy via anatomical reference sizing techniques, or via anatomical features obtained from imaging examinations in batch productions able to be validated and reproduced.
Patient-specific devices will require registration with ANVISA under the new regulatory system for custom-made devices.
This new regulation will define specific criteria based on the device risk classification for the notification of custom-made manufacturing, importation and vigilance responsibilities, as well as detail a clearer Brazilian market pathway for patient-specific and adaptable medical devices.
june 17, 2019_EUROPE (EUROPEAN COMMISSION)
Medical devices: change of legislation What you need to know!
​This factsheet is aimed at healthcare professionals and health institutions.
JUNE 14, 2019_EUROPE
UK – UK NB Will Not Apply for EU MDR/IVDR
London-based Lloyd’s Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR).
​LRQA directed clients to choose an alternative NB and establish a team to help with transition activities, with the goal of minimizing the risk of disruption. Citing the need to ease the transition, LRQA said it is providing 90 days’ notice rather than the required 30 days…
JUNE 14, 2019_AUSTRALIA (TGA)
Important annual charge deadlines
Sponsors are reminded that if their product is no longer supplied, they can cancel their entry from the ARTG. Products on the ARTG on 1 July 2019 will incur a 2019-20 annual charge (unless exempt).
2019 important dates for annual charges
JUNE 6, 2019_SPAIN (AEMPS)
notificaps.aemps.es/enviotelematico/notificaps/notifica/inicio.do
JUNE 6, 2019_CHINA (NMPA)
China adjusts requirements for clinical trials of medical devices
Under the new guidelines, which apply to all renewing or applying for new device product registrations, firms may request a consultation with the NMDA’s Medical Device Technology Center (CMDE). If they do not receive feedback within 60 days of their request, they may proceed with the clinical trial.
The CMDE will publish the name, address and acceptance number of the applicant, along with the product name, product model specification, structure, and composition of the medical device, on its website. Applicants will be informed online only of the results of the inspection of the clinical trial sites.
JUNE 6, 2019_EUROPE (EUROPEAN COMMISSION)
Publication of a new document by the Medical Device Coordination Group (MDCG)
MDCG 2019-6 Questions and answers: Requirements relating to notified bodies
The document presents questions and answers on requirements relating to notified bodies under MDR and IVDR. The issues covered by this document have been identified in the context of joint assessments.
JUNE 4, 2019_CHINA (nmpa)
The NMPA has clarified various technical review and information guidelines related to medical device registration and approval.
Requests for predicate device performance parameters
NMPA has issued a notification clarifying how registrants should apply to the regulator to obtain performance parameters of appropriate predicate devices in order to produce clinical evaluation reports (CER).
ePRS system implementation
NMPA plans to fully implement the electronic medical device registration management system, the ePRS system on June 24, 2019. The manufacturers may use ePRS for initial registration, renewal and modification submissions for certain devices: domestic Class III devices and imported Class II and III devices. In addition, ePRS will be used for electronic applications related to clinical trial approvals, Indications for Use change notifications and other regulatory review processes.
New technical review guidelines
New technical review guidelines for device types including synthetic resin teeth, intra-uterine devices and implantable drug delivery devices. These guidelines explain technical data China registration applicants should provide in their submissions to NMPA reviewers.
MAY 30, 2019_HEALTH CANADA
This updated version is now in line with the Department's Good Guidance Practices and includes the following key changes: the removal of information specific to Investigational Testing Authorizations (this information is now available in Applications for Medical Device Investigational Testing Authorizations Guidance Document - Summary); additional information regarding Private Label Licence Applications (new and amendments); and, a streamlined appeal process with the removal of the requirement for a letter of intent to appeal.
MAY 29, 2019_AUSTRALIA (TGA)
GMP clearance fees
​As such, from 1 July 2019, the revised GMP clearance fees (per manufacturer, per site, per sponsor) will be implemented as per following:
Application processing fee will increase from $400 to $650
Compliance Verification (CV) fee will increase from $2070 to $2480
​These changes will apply when an application for a GMP clearance is submitted on or after 1 July 2019.
MAY 24, 2019_INTERNATIONAL (IMDRF)
Personalized Medical Devices - Regulatory Pathways​
A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Personalized Medical Devices Working Group is provided below for public comment.
This consultation closes on Wednesday 24 July 2019.
The purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each category of personalized medical device.
MAY 23, 2019_AUSTRALIA (TGA)
​The TGA is required to recover its costs for all activities that fall within the scope of the Therapeutic Goods Act 1989, including the TGA's public health responsibilities.
A fee is charged for a service, such as a product evaluation.
A charge is a form of tax imposed on the regulated industry and is applied annually based on a 1 July to 30 June financial year.
​This guidance is a summary of fees and charges, which are in the Australian therapeutic goods legislation. This is not an exhaustive list.
MAY 23, 2019_EUROPE (GMED)
Guide "Transitional provisions of Regulation (EU) 2017/745"_April 2019
​The purpose of this guide is to help manufacturers to determine whether the change to the purpose (destination) or design of the device is a significant change referred to in Article 120 (3) MDR.
MAY 17, 2019_USA (FDA)
This web page focuses on the use of patient-reported outcomes (PRO) as one type of patient input.
How CDRH Uses PROs in Regulatory Decision Making
CDRH Collaborations, Studies, Articles, and Workshops on Patient-Reported Outcomes
Planning to Incorporate Patient-Reported Outcome Measures (PROMs) in a Regulatory Submission?
MAY 16, 2019_USA (FDA)
​​The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.
When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device postmarket surveillance, and facilitate medical device innovation.
Global Unique Device Identification Database (GUDID)​
​The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog for every device with a unique device identifier (UDI).
GUDID contains ONLY the device identifier (DI) portion of the UDI, which serves as the key to obtain device information in the database. While GUDID does not include production identifiers (PIs), GUDID contains PI flags to indicate which PI attributes are in the UDI.
MAY 15, 2019_HEALTH CANADA
Final Report: Fees for Drugs and Medical Devices​
This document presents a summary of stakeholder comments and concerns, Health Canada’s responses and the Final Fees for Drugs and Medical Devices which come into force April 1, 2020. ​
The purpose of this document is to provide the performance standards to be used to determine whether a remission should be granted, under the Fees in Respect of Drugs and Medical Devices Order (Order), to a person who must pay a fee under that Order.
MAY 15, 2019_AUSTRALIA (TGA)
Medical device annual reporting - Sponsor obligations
​All sponsors of medical devices included on the Australian Register of Therapeutic Goods (ARTG) must comply with certain automatic conditions of inclusion.
For sponsors of Class IIb (implantable) and Class III devices, AIMD or Class 4 IVD, these obligations include submitting annual reports to the TGA for the first three years of inclusion in the ARTG. Annual reports are due on October 1 of each year.
In previous years as a matter of courtesy, the TGA has issued a formal correspondence requesting the information under s41JA of the Act. This practice will not be continued. This was disseminated to industry representatives as Item 2.2 of the RegTech Forum on 28 February 2019. No objections were raised at the meeting in regard to this change of practice.
Failure to provide the information by the due date will result in regulatory action.
MAY 14, 2019_EUROPE (EMA)
​The European Medicines Agency (EMA) plans on publishing a series of guidance documents to assist applicants in the medical device industry in preparation of the obligations delivered by the new Regulation (EU) 2017/745 on medical devices. This guidance document falls within the scope of EMA’s activities and should be read in alignment with the new Regulations (EU) 2017/745 on medical devices and (EU) 2017/746 on In Vitro Diagnostic medical devices.
The first questions and answers (Q&A) document, focuses on Article 117 of the Regulation (EU) 2017/745 on medical devices . The document states that marketing authorization applications for medicinal products with an integral medical device shall include opinion from a Notified Body. It is approximated that one in four centrally authorized medications often includes a medical device component.
Note: In early June 2019 EMA will publish a draft guideline on quality requirements for regulatory submissions for medicines that include a medical device (drug-device combinations). The guidance will cover devices which are integral, co-packaged or supplied separately.
​https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
MAY 14, 2019_INTERNATIONAL (AFNOR)
PR NF EN ISO 10993-23​ "Biological evaluation of medical devices - Part 23: Tests for irritation"
Voting terminates on: 2019-07-31
MAY 13, 2019_EUROPE (MDDI)
MAY 8, 2019_EUROPE (MEDTECH EUROPE)
Additionally, in Annex 2 of the present guidance MedTech Europe recommends symbols to be used with patient implant card
MAY 7, 2019_FRANCE (LCH)
The New French Anti-Kickback Legislation
This article reviews some of the more important changes to the existing French anti-kickback legislation that are expected to go into effect in 2019.
MAY 6, 2019_USA (FDA)
Guidance "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program"_Document issued on May 7, 2019
The purpose of this guidance is to provide an overview of the mechanisms available to submitters through which they can request feedback from or a meeting with the FDA regarding potential or planned medical device IDE applications, Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, Evaluation of Automatic Class III Designations (De Novo requests), Premarket Notification (510(k)) Submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications (CW), Dual 510(k) and CLIA Waiver by Application Submissions (Duals), Accessory Classification Requests, and certain Investigational New Drug Applications (INDs) and Biologics License Applications (BLAs) submitted to the Center for Biologics Evaluation and Research (CBER)) (specifically, INDs and BLAs for devices that are regulated as biological products under section 351 of the Public Health Service (PHS) Act).
https://www.fda.gov/media/114034/download
MAY 3, 2019_EUROPE (EUROPEAN COMMISSION)
EC Explains What UDI Information to Provide for Eudamed
MDR - UDI and device data sets to provide in EUDAMED
IVDR - UDI and device data sets to provide in EUDAMED
EUDAMED UDI Device Data Dictionary
MAY 2, 2019_USA (FDA)
​This page is designed to provide you with information on mandatory reporting requirements and procedures.
Voluntary Malfunction Summary Reporting Program
Patient Preference-Sensitive Areas: Using Patient Preference Information in Medical Device Evaluation
The FDA believes that patients can and should bring their own experiences to bear in helping inform the agency’s evaluation of medical devices over the total product lifecycle. This kind of input can be important to consider during the FDA’s decision-making for medical devices including in clinical studies, benefit-risk assessments, and postmarket surveillance.
List of Patient Preference-Sensitive Areas: https://www.fda.gov/about-fda/cdrh-patient-engagement/priority-list-patient-preference-sensitive-areas
MAY 2, 2019_germany
Establishment of an Implants Registry
At the beginning of April 2019, the Federal Cabinet has adopted the draft of a "Law on the Establishment of an Implant Registry in Germany and other amendments to the Fifth Book of the Social Code” (Implants Registry Establishment Law, Implantateregister-Errichtungsgesetz, EIRD).
The goal of the Registry is to improve the safety and quality of implantations for both privately and publicly health insured. By scientific assessment of the collected data, such as the lifetime of implants in the body, conclusions can be made, inter alias about the quality of the implants and the quality of the implanted devices.
MAY 1, 2019_USA (FDA)
​The FDA's Center for Devices and Radiological Health's (CDRH) is reorganizing to create an agile infrastructure that can adapt to future organizational, regulatory and scientific needs. This reorganization does not change the mission of CDRH or any MDUFA IV timelines.
Implementation of the reorganization will take a phased approach that began on March 18, 2019, and omcplete implementation is expected by the end of September 2019.
CDRH is taking that step by operationalizing its new office responsible for these functions, the Office of Product Evaluation and Quality (OPEQ).
https://www.fda.gov/about-fda/cdrh-offices/office-product-evaluation-and-quality
APRIL 30, 2019_HEALTH CANADA
Guidance Supporting Evidence for Implantable Medical Devices Manufactured by 3D Printing
The document provides guidance for manufacturers regarding specific evidence required to support pre‐market Class III and Class IV licence applications for implantable medical device manufactured by 3D printing processes. Considerations related to the design and manufacturing process, material controls, device testing, and labelling of 3D printed devices are included in this document. Requested information may vary in terms of content and level of detail depending on the 3D printing process (or processes) and the risk class of the finished device.
APRIL 30, 2019_BRAZIL (ANVISA)
Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements.
APRIL 30, 2019_UK (BREXIT)
Art. 50 is extended till October 31st 2019.
It appears the UK doesn’t want to jump and the EU doesn’t want to push, so for now the UK is balancing on the cliff-edge of Brexit.
The real problem is that UK negotiators do not have a clear mandate.
Any result is still possible, so Emergo’s advice remains: prepare for the worst, hope for the best.
UK companies are being cut out of EU networks due to this uncertainty.
april 25, 2019_USA (FDA)
Guidance "Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions"
​The FDA has developed this document to describe relevant information that should be included in test report summaries, test protocols and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).
​https://www.fda.gov/media/113230/download​​
Guidance "Unique Device Identification: Convenience Kits"
​This guidance describes FDA’s interpretation of the definition of “convenience kit” at 21 CFR 801.3 and as used in 21 CFR 801.30(a)(11). This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to the IVD labeling requirements under 21 CFR part 809, nor does it apply to combination products as defined in 21 CFR 3.2(e).
​The agency now considers the definition of convenience kit “to mean a device that contains two or more difference medical devices packaged together and intended to remain packaged together.”
​https://www.fda.gov/media/95120/download
APRIL 25, 2019_EUROPE (EUROPEAN COMMISSION)
State of play of joint assessments of Notified Bodies in the medical device sector_Update April 23, 2019
The Commission received a total of 38 applications for the MDR (10 more), and 9 requests for IVDR (2 more)
27 preliminary reports reached the Commission for the MDR (7 more), and 6 reports for IVDR (1 more)
Following joint evaluations and review of corrective action plans, 7 "opinions" were issued by the joint assessment team (3 more are in preparation), and 2 final reports were issued by authorities responsible for the designation of Notified Bodies. This means that the designation of new Notified Bodies according to the MDR and the IVDR should take place soon, but we still do not know when or which Notified Bodies are involved.
APRIL 24, 2019_FRANCE (CCAM)
Classification Commune des Actes Médicaux_Publication de la version 57
La CCAM v57 permet la mise en œuvre au 11/05/2019 : création de 3 actes, d’ajout de notes de facturation, d’associations ou de suppression d’acte, de gestes complémentaires, de codes regroupements. Elle corrige au 02/04/2019 des libellés, notes, code regroupement et incompatibilités d'associations.
Télécharger le document : CCAM V57 PDF ​
APRIL 23, 2019_USA (FDA)
CDRH Learn Module: An Introduction to FDA’s Regulation of Medical Devices
​An Introduction to FDA’s Regulation of Medical Devices (New module 4/23/19)
APRIL 22, 2019_india (CDSCO)
APRIL 22, 2019_JAPAN (PMDA)
​According to a notification (link in Japanese) from the Japanese Pharmaceutical and Medical Devices Agency, the decision to continue participation means MDSAP certificates will remain valid for Japanese quality management system requirements and audits through March 2020. The government has been determining whether to continue MDSAP participation on an annual basis since 2016.
APRIL 20, 2019_KOREA (MFDS)
​The Korean Ministry of Food and Drug Safety (MFDS) announced changes to the requirements for Korea Good Manufacturing Practice (KGMP) certification. Any company applying for new or renewal KGMP certificates after July 1, 2019 will be subject to the following new requirements:
1. KGMP reference standard will be changed from ISO 13485:2003 to ISO 13485:2016
2.On-site inspection of contract manufacturing sites will increase
3. Additional documents will be made mandatory for KGMP application
APRIL 18, 2019_USA (FDA)
Documents for ​Non-Clinical Assessment of Medical Devices containing Nitinol
As part of a broader effort to address potential safety issues from materials in medical devices, FDA proposed technical considerations for nitinol-containing devices.
Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol - Draft Guidance for Industry and Food and Drug Administration Staff
FDA In Brief: FDA outlines considerations on medical devices containing the metal alloy nitinol as part of ongoing efforts to evaluate materials in devices to address potential safety questions
Federal Register: Technical Considerations for Non-Clinical Assessment of Medical Devices Containing Nitinol
This document has a comment period that ends in 60 days. (06/18/2019)
​The FDA has finalized a list of accessories that can be classified as Class 1 devices. The listing was required under the FDA Reauthorization Act of 2017.
The agency said it was willing to classify accessories as low-risk as long as they don’t support or sustain life, don’t present an unreasonable risk of injuries or illnesses and if Class 1 general controls assure reasonably low-risk.
The list includes specific accessories for biopsy instruments, stents and catheters, as well as other accessories used in surgery.
APRIL 18, 2019_PHILIPPINES (FDA)
​The Philippines FDA intended to implement the first two phases of the new medical device regulatory system (known as Administrative Order 2018-0002) on April 11, 2019, however the implementation date has been delayed. Extra time is needed for the CDRRHR to finalized guidelines for classification and grouping, etc.
https://www.asiaactual.com/wp-content/uploads/2018/01/AO-2018-002-Medical-Device-Registration-Requirement.pdf
APRIL 17, 2019_HEALTH CANADA
Updated Medical Devices Licence Application Fee Form
Use this version of the Medical Devices Licence Application Fee Form if you will be filing on or after April 1st, 2019.
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/dhp-mps/alt_formats/pdf/md-im/applic-demande/form/md_licapp_demhom-2019-eng.pdf
APRIL 17, 2019_USA (FDA)
New white paper "How ISO 13485:2016 Will Impact Your Medical Device Development - Part 2: ISO 13485 and FDA' Design controls"
The white paper explores the differences between the old and new versions of ISO 13485, as well as the anticipated FDA updates later in 2019. Taking a high-level look at these changes, we then assess their impact for medical device organizations. In addition, we try to understand the opportunities and challenges presented in adopting the standard for your organization’s quality management system (QMS).
APRIL 16, 2019_europe
APRIL 15, 2019_EUROPE (EUROPEAN COMMISSION)
Publication of 2 new documents by the Medical Device Coordination Group (MDCG)
MDCG 2019-4 Timelines for registration of device data elements in EUDAMED
The document clarifies that device data should be registered to EUDAMED “18 months after the general application date or, if EUDAMED is not fully functional on time, from 24 months after the date of publication of the notice referred to in Article 34(3)”. It means that registrations should be done until November 2021 or May 2022 in case EUDAMED is not ready.
https://ec.europa.eu/docsroom/documents/34921?locale=en
According to this document, legacy devices could be registered to EUDAMED without a UDI (unique device identifier).
https://ec.europa.eu/docsroom/documents/34922?locale=en
Update of the document (April 2019)
​This Rolling Plan contains the list of identified essential implementing acts, actions and guidance to be put in place by the Commission and/or the MDCG during the transitional period together with relevant information on expected timelines and state-of-play. The information is organised into two main sections (implementing acts; other actions/initiatives). The document will be subject to quarterly review in order to provide the authorities and stakeholders with the most updated information.
APRIL 14, 2019_SNITEM (FRANCE)
Publication de nouveaux documents:
Comment un acte, et le dispositif médical associé, peuvent-ils être remboursés s'ils sont utilisés à l'hôpital ?
https://www.snitem.fr/le-snitem-en-action/les-publications/acces-au-remboursement-des-actes-a-lhopital
Comment un dispositif médical à usage individuel est-il remboursé en ville ?
​https://www.snitem.fr/le-snitem-en-action/les-publications/acces-au-remboursement-des-dm-en-ville
APRIL 11, 2019_EGYPT (CAPA)
​CAPA’s fast-track review process entails the following steps:
Compiling your device technical file;
Requesting an application submission date from CAPA;
Submitting your technical file to CAPA;
Receiving review decision from CAPA within 90 days of submission.
APRIL 4, 2019_USA (fda)
​Scaling risk seems somewhat subjective, so how can this be reliable?​
APRIL 4, 2019_AUSTRALIA (TGA)
​On 4 April 2019, the 'Action Plan for Medical Devices' was released.
Whilst the regulatory requirements in Australia are some of the most stringent in the world, more can be done to further strengthen the system, placing patient safety first.
The Action Plan is a three part strategy to:
provide more information to patients about the devices they use
The Action Plan provides an overview of the current regulatory system, what actions are proposed and the timeframes for these.
APRIL 3, 2O19_INTERNATIONAL (IMDRF)
Proposed update to Clinical Evaluation documents
Proposed Documents have been released by the International Medical Device Regulators Forum (IMDRF) Medical Devices Clinical Evidence Working Group.
This consultation closed on Wednesday 5 June 2019.
APRIL 2, 2019_ITALIA (MINISTRY OF HEALTH)
Publication of a new document on medical device governance
The document presents the guidelines for a new governance of medical devices, which aims at the efficient allocation of the NHS resources, the sustainability of innovation, the strengthening of supervision and the transparency of actions and reports concerning the procurement and use of medical devices.
www.salute.gov.it/imgs/C_17_notizie_3681_listaFile_itemName_0_file.pdf
APRIL 1, 2019_KOREA (mfds)
Korea tightens quality control for medical device tests
​Moving to align its quality control requirements for medical devices with international standards, South Korea’s primary regulatory body, the Ministry of Food and Drug Safety (MFDS) will begin implementing Good Laboratory Practices (GLP) regulations on medical devices beginning May 1, 2019.
The regulations require conducting medical device safety tests in government authorized laboratories, and mandate close reporting and monitoring of the tests to ensure the quality and validity of the data produced.
The new requirements will increase the cost to manufacturers – of gaining medical device approval in Korea. They will also mean a longer time to get new products to market. Before, tests conducted by local laboratories were acceptable as long as they were approved by MFDS, now only tests conducted in laboratories strictly aligned with GLP will be in compliance.
In tightening its testing regulations, South Korea is seeking to ensure compliance with universal quality standards for the design, manufacture, export, and sales of various medical devices. Adopting the new standard would also smooth Korea’s participation in the International Medical Device Single Audit Program, facilitating speedier approvals of devices in the future.
APRIL 1, 2019_PHILIPPINES (FDA)
Philippines medical device requirements go into effect​
The Philippines Food and Drug Administration on April 11 will begin implementing new rules that require registration of most medical devices imported, marketed or manufactured in the archipelago nation.
The rules, in the works for more than a year, are expected to increase costs for medical device manufacturers doing business in the country. The rules establish four classes of registration for medical devices and include notification requirements and fees in accordance with safety risk, as determined by the Philippines FDA. Previously, not all medical devices required registration.
Initially, just those devices categorized as Class A will be subject to the new rules. Implementation dates for Class B, C and D devices have not been set. The grace period for compliance with the new rules is expected to be set at one year.
APRIL 1, 2019_FRANCE (HAS)
Dépôt d'un dossier médicament ou dispositif médical
Plateforme Sésame en ligne. Liste des démarches:
APRIL 1, 2019_japan (PMDA)
Japanese regulators increase medical device registration fees for 2019​
​Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has increased registration, inspection and related regulatory fees for medical device market applicants.
The new fees have taken effect as of April 1, 2019 (link in Japanese). PMDA has issued three related documents to provide additional details regarding these increases:
Explanation of the Japanese Ministry of Health, Labour & Welfare’s order authorizing new PMDA registration fees, with related comparison tables;
Notice to Japanese regional authorities regarding implementation of revised PMDA fee structures;
Explanation of how PMDA will manage acceptance of registrations under previous versus new fee structures. (All links in Japanese.)
APRIL 1, 2019_GMDN
The GMDN, the de facto global standard for identifying the world’s millions of medical devices, has been made freely available to all users for the first time on 1st April 2019.
The new free Basic membership will allow users access to the GMDN data, while the existing membership charges will remain for manufacturers needing the time-saving and value-added services provided by the GMDN Agency. These include the Term Status Notification service (which automatically updates subscribers to change events), multi-user accounts, data export, access to the higher-level Explorer groups and a priority enquiry service.
MARCH 29, 2019_USA (FDA)
Drafts Guidance on Inspections of Medical Device Establishments
The US Food and Drug Administration (FDA) issued draft guidance to implement uniform processes and standards for FDA inspections of domestic and foreign medical device establishments.
FDA has updated processes and standards for uniformity within and across inspections other than for-cause and to establish a standard timeframe for such inspections of device establishments. The uniformity in FDA investigators’ approaches to these inspections “may inform firms’ preparation for the inspection and set baseline communication and timing expectations for each party.
MARCH 27, 2019_UK (MHRA)
​MHRA registration timelines
Within four months after Brexit for Class III devices, Class llb implantable devices, active implantable devices and IVD List A devices;
Within eight months after Brexit for Class llb non-implantable devices, Class lla devices, IVD List B devices and Self-test IVDs;
Within 12 months after Brexit for all other devices (Class I and self-certified IVDs).
MARCH 26, 2019_usa (FDA)
Latest News on Sterigenics and Other Sterilization Facility Closures
CDRH Learn Module: Exporting Medical Devices
​New module 3/26/19
MARCH 22, 2019_BREXIT
Brexit delay: Reduced risk of no-deal withdrawal for medical device manufacturers?
No Brexit on March 29th;
Vote set for next week on agreement in UK parliament;
Delay until May 22rd with conditions;
New Brexit day on April 12th if no agreement is accepted.
MARCH 22, 2019_USA (FDA)
CDRH Learn Module - How to Complete Form FDA 3602A: MDUFA Foreign Small Business Certification Request For a Business Headquartered Outside the United States
MARCH 22, 2019_EUROPE (EUROPEAN COMMISSION)
MDCG 2019-3 Interpretation of Article 54(2)b
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
www.raps.org/news-and-articles/news-articles/2019/3/eu-mdrivdr-coordination-group-urges-exemption-cla
MARCH 21, 2019_AUSTRALIA (TGA)
MARCH 20, 2019_INTERNATIONAL (IMDRF)
IMDRF/RPS WG/N27 FINAL:2019: Assembly and Technical Guide for IMDRF Table of Contents Submissions
www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-190124-assembly-technical-guide-toc-submissions-n27.pdf
MARCH 19, 2019_BREXIT
MHRA released 16 new and updated guidance documents, mostly related to marketing authorizations, variations and licensing.
For medical devices: Regulating medical devices in the event of a no deal scenario
MARCH 19, 2019_HEALTH CANADA
MARCH 19, 2019_EUROPE
Corrigenda Regulations Medical Devices_Brussel March 13, 2019_Council of the European Union
​As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda.
Corrigendum for the Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Official Journal of the European Union L 117 of 5 May 2017)
​data.consilium.europa.eu/doc/document/ST-15409-2018-REV-1/en/pdf
Corrigendum for the Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Official Journal of the European Union L 117 of 5 May 2017)
​data.consilium.europa.eu/doc/document/ST-15418-2018-REV-1/en/pdf
MARCH 18, 2019_USA (FDA)
Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren on Friday announced plans to improve the agency’s approach to evaluating material safety and biocompatibility.
While FDA already evaluates the materials used in implantable and insertable devices, Gottlieb and Shuren said the agency is looking for ways to enhance these evaluations beyond the recommendations made in a 2016 guidance on biocompatibility evaluations.
MARCH 14, 2019_HEALTH CANADA
Health Canada Begins Release of Clinical Data on Drugs and Devices​
Health Canada launched two public databases as the first step in making clinical information about the safety and effectiveness of drugs and medical devices publicly available.
MARCH 13, 2019_EUROPE
Draft document "Joint Industry Position on Significant Changes" According to MDR Article 120(3)
A common interpretation document of Article 120 (3) of the Medical Devices Regulation (MDR) was proposed on 19 February 2019 by European manufacturers, represented by 4 professional associations:
– AESGP (Association of the European Self-Medication Industry)
– COCIR (European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry)
– EUROMCONTACT (European Association of the Contact Lens and Lens Care
Products Manufacturers)
– MedTech Europe ( European trade association for the medical technology industry including diagnostics, medical devices and digital health)
Article 120 (3) of the Regulation explains that one of the conditions for a CE-marked medical device according to Directive 93/42/EEC to still be put on the market after 26 May 2020 is that have no significant change in design and purpose. The whole question is how to interpret this notion of "significant change": the industry therefore proposed this 14-page document. It contains in the appendix a main flow chart and five subsidiary logigrams, which help to decide whether a change should be considered significant or not, including for software.
march 12, 2019_FRANCE (JORF)
Tarifs GHS/GHM 2019_Publication JORF
Publication au JORF du 12 mars 2019 de l'arrêté du 6 mars 2019 fixant pour l’année 2019 les éléments tarifaires mentionnés aux I et IV de l’article L. 162-22-10 du code de la sécurité sociale
MARCH 12, 2019_HEALTH CANADA
​Poster to share "Help stop illegal marketing of drugs and devices"
https://www.canada.ca/content/dam/hc-sc/documents/services/publications/drugs-health-products/stop-illegal-marketing-infographic/stop-illegal-marketing-infographic.pdf
LEARNING about Illegal Marketing of Drugs and Devices in Canada at canada.ca/drug-device-marketing
REPORTING illegal marketing practices at drug-device-marketing@canada.ca
MARCH 7, 2019_FRANCE (CCAM)
Classification Commune des Actes Médicaux_Publication de la version 56
La CCAM v56 permet la mise en œuvre au 01/04/19 de créations, modifications et suppressions d'actes, de suppléments, de gestes complémentaires, de codes regroupements, de forfaits CMUC.
Télécharger le document : CCAM V56 PDF
MARCH 6, 2019_EUROPE (EUROPEAN COMMISSION)
EUDAMED : Draft Functional specifications
MARCH 6, 2019_AUSTRALIA (TGA)
In the event of a 'no deal' exit of the United Kingdom (UK) from the European Union (EU), the TGA will implement transitional arrangements to provide for minimal interruption in the supply of medical devices in Australia.
​If there is a 'no deal' Brexit, the TGA will continue accepting conformity assessment documents issued by UK notified bodies for existing products while these remain current for the purposes of UK market authorisation. This will apply to both existing Australian Register of Therapeutic Goods (ARTG) entries and applications for new inclusions of medical devices in ARTG:
The Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018will be amended to specify the conformity assessment documents issued by UK notified bodies that may accompany an application for inclusion in the ARTG.
Consultations (closed on 29 April 2019)
​These consultation papers consider the EU regulatory framework as an input into the review and reform of the Australian regulatory requirements for medical devices classification.
MARCH 5, 2019_EUROPE
The European Commission has just designated the Italian Nomenclature, CND, as the reference nomenclature for the EUDAMED database. This decision comes under Article 26 of the new Regulation 745/2017.
It should be noted that the interface between the CND and the GMDN, until then the international reference nomenclature, will be ensured.
In accordance with Articles 23 IVDR and 26 MDR, having due regard to the views provided by the MDCG, the CND nomenclature, to be mapped to the GMDN nomenclature, will be made available in the future Eudamed.
​http://www.salute.gov.it/portale/temi/p2_6.jsp?id=328&area=dispositivi-medici&menu=classificazione
MARCH 5, 2019_EUROPE (ANSM)
Corrigendum of the Medical Device Regulation
Analysis of information in the minutes of the ANSM session / professional organizations of January 11, 2019.
The Commission has prepared a corrigendum to the MDR. It is proposed to extend the transitional measures to Class I devices which require the use of a Notified Body (NO) or Class I devices which change class with regard to MD regulation, so as to avoid overloading the NBs. While a large majority of the competent authorities are in favor of this measure, there are divergences as to its legal form.
www.ansm.sante.fr/var/ansm_site/storage/original/application/4f2607408a39d61c2b00e4982bb97e80.pdf
MARCH 1, 2019_VIETNAM (DMEHW)
MARCH 1, 2019_FRANCE (HAS)
À partir du 2 avril 2019, le dépôt de dossiers pour les évaluations des dispositifs par la HAS se fera uniquement en ligne via une plateforme dédiée. Les envois papiers ne seront plus possibles.
Pour pouvoir soumettre une demande, vous devez au préalable demander la création d’un compte d’accès. Pour les entreprises ayant déjà déposé un dossier par le passé, un lien a dû être envoyé directement par mail avant fin février.
Si vous n'avez pas reçu de mail début mars et pour plus d’information, écrivez-nous.
Pour plus d'information, consultez notre FAQ dédiée.
MARCH 1, 2019_AUSTRALIA (TGA)
ISO 13485:2016 transition period ending_What does this mean for medical device manufacturers?
If you are relying on compliance with ISO 13485 to demonstrate conformity with the QMS requirements of the Australian conformity assessment procedures:
TGA audits
​From 1 January 2019, all TGA audits are conducted against the 2016 revision of the standard, as previously announced: Medical device quality management systems: transition to new standard
TGA issued ISO 13485 QMS Certificates
​All TGA issued ISO 13485:2003 QMS Certificates will expire by 1 March 2019 and cannot be extended beyond the end of the transition period. The TGA can only issue ISO 13485:2016 QMS Certificates to manufacturers who we have audited against the new revision of the standard. If you require a TGA audit to ISO13485:2016 for a new QMS Certificate, contact: QMS.Certificates@health.gov.au.
Applications for TGA Conformity Assessment
​From 1 March 2019, conformity assessment applications must be supported by evidence that a quality management system has been implemented in accordance with the 2016 revision of the standard.
For applications lodged prior to the end of the transition period, QMS evidence based on ISO 13485:2003 will be considered as part of the application process. The TGA will advise applicants if additional QMS evidence is required to support issuing of a Conformity Assessment Certificate.
Manufacturers holding a current TGA issued conformity assessment certificate
​​You are not required to submit any additional information to the TGA at this time if you hold:
a current TGA issued conformity assessment certificate for Therapeutic Goods (Medical Devices) Regulations - Part 1 excluding clause 1.6, Part 4 or Part 5, and
are not currently seeking TGA approval for substantial changes or re-certification, or
are not currently seeking a TGA issued ISO13485:2016 QMS Certificate.
february 28, 2019_HEALTH CANADA
The International Medical Device Regulators Forum (IMDRF) has identified the need to harmonize the format of medical device market authorization applications. In support of this objective, Health Canada has consolidated existing guidance and IMDRF Guidance into a new set of tools and guidance pages.
​The Health Canada IMDRF ToC Implementation Guidance includes content relating to:
Format/Structure requirements
Assembly and system requirements
With the exception of Special Access and Investigational Testing Authorizations, pre-market and post-market activities are within the scope of implementation of the ToC. For a complete, detailed, and up to date listing of regulatory activities within scope for the ToC implementation, refer to the main Draft Health Canada IMDRF ToC for Medical Device Applications Guidance.
FEBRUARY 28, 2019_EUROPE (EMA)
EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices. The new regulations introduce new roles and responsibilities for EMA and national competent authorities (NCAs) in relation to certain types of medical devices and in-vitro diagnostics.
FEBRUARY 27, 2019_BRAZIL (ANVISA)
Notification pathway for Class I devices nearing publication in BrazilBrazil’s medical device regulator ANVISA is nearing implementation of a new “notification” market pathway for low-risk devices.
Once ANVISA’s notification regulation is implemented, applicants’ documentation obligations will be similar to existing Class I cadastro requirements, which include technical dossiers and AVISA application forms. Applicants must also provide proof of relevant certifications such as INMETRO and ANATEL.
Once submitted, Class I device applications will not undergo technical reviews; instead, such devices will be notified to ANVISA once applications and fees have been received by the agency. The regulator intends to issue notification numbers to applicants within 30 days of receipt of submissions.
ANVISA plans to publish notifications only on its own website, not in the Official Diary. Manufacturers may begin marketing their devices in Brazil once they have received notification numbers and added them to their product labeling.
FEBRUARY 26, 2019_UK (MHRA)
Update of the guidance "Register as a manufacturer to sell medical devices
Added a link to new guidance on medical devices regulation in a no deal scenario
FEBRUARY 26, 2019_HEALTH canada
List of Recognized Standards for Medical
FEBRUARY 22, 2019_PHILIPPINES ( FDA)
Philippines new medical device regulations to launch April 11th
The Philippines FDA provided important guidance related to the new Medical Device Regulations at a public forum held in Manila on February 22nd. The target date for implementation of AO 2018-0002 was announced for April 11, 2019. At that time, Class A, B, C and D medical devices will require a Certificate of Medical Device Notification (CMDN) in order to be imported and placed on the market in the Philippines. The grace period for compliance will be announced in March and is expected to be 12 months.
February 2019_INTERNATIONAL STANDARD
ISO 11607-1 (2019)
News affecting IFU & usability => Expedited implementation is recommended in order to comply with the MDR
Additions in IFU for inspection of sterile barrier systems immediately prior to use, for evidence of a breach in integrity of the sterile barrier
New requirements appears for usability of aseptic presentation.
FEBRUARY 22, 2019_FRANCE (HAS)
Frequently Asked Questions_Electronic filing
On February 22, 2019, the High Authority for Health (HAS) published a "Frequently Asked Questions" concerning the filing of electronic files. A platform called "SESAME" has been set up, which allows in particular to file files with the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS).
FEBRUARY 21, 2019_EUROPE-US
U.S. and EU Agree to Work Together on UDI Standards​
The U.S. and the EU have pledged to cooperate to ensure that electronic database specifications for unique device identifiers (UDIs) are in alignment, according to a report by the European Commission.
The two jurisdictions will develop a plan for a bilateral test of compatibility of respective UDI databases to go with ongoing efforts within the International Medical Device Regulators Forum, according to the commission’s Executive Working Group.
FEBRUARY 21, 2019_USA (FDA)
The US Food and Drug Administration (FDA) final rule that requires foreign clinical investigations for medical devices to comply with good clinical practice (GCP) requirements came into effect on Thursday.
The 2018 final rule is intended to provide consistency in the agency’s requirements for the acceptance of data derived from medical device clinical investigations, regardless of the type of marketing submission or application and whether the investigation was conducted in or outside of the US.
2 new documents issued:
Refuse to Accept Policy for 510(k)s - Guidance for Industry and Food and Drug Administration Staff
​The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review.
​The purpose of the PMA acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete for the Agency to undertake a substantive review. ​
FEBRUARY 20, 2019_FRANCE (HAS)
Publication de 2 documents par la La commission nationale d’évaluation des dispositifs médicaux et des technologies de santé (CNEDiMTS)
un guide à visée didactique destiné à aider les entreprises qui fabriquent ou exploitent des DMC à anticiper les exigences cliniques requises par la CNEDiMTS pour déterminer l’intérêt d’un DMC en vue de sa prise en charge par la solidarité nationale.
Le rapport d’élaboration de ce guide intégrant l’analyse de la littérature, les données des autres agences d’évaluation (réseau INaHTA), les dossiers des DMC déjà évalués par la CNEDiMTS, les schémas d’études recensés sur les bases de données d’essais cliniques, la consultation des diverses parties prenantes ainsi la position d’un groupe de travail multidisciplinaire mobilisé sur cette thématique.
​Rapport méthodologique d'évaluation clinique d'un dispositif médical connecté
February 18, 2019_FRANCE
​Sans attendre la mise en œuvre de cette nouvelle réglementation, le ministère des Solidarités et de la Santé, en lien avec l’agence nationale de sécurité du médicament et des produits de santé (ANSM), la Haute Autorité de Santé (HAS) et la Caisse Nationale pour l’Assurance Maladie (CNAM), a mis en place plusieurs actions selon les trois axes principaux suivants :
- Renforcer l'évaluation et l'encadrement des pratiques de poses des DM notamment pour les plus à risque
- Garantir la traçabilité de DM implantables dans les établissements de santé afin de faciliter la transmission des signaux mêmes faibles de matériovigilance
- Faire évoluer la base Transparence Santé et étendre les exigences actuelles en matière de transparence et de lien d'intérêt
FEBRUARY 15, 2019_USA (fda)
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments - Draft Guidance for Industry and Food and Drug Administration Staff
The guidance presents under which conditions an establishment that has been the subject of an inspection by the FDA that gave rise to the issue of "observations" (Form 483, corresponding to non-conformities) may apply to the FDA to seek advice on what steps it intends to take to address these concerns.
The establishment must make its request within 15 days after the observations are issued, and this application must meet one of the following criteria:
- involve a priority for public health;
- involve systemic or major actions;
- be related to emerging security issues (as defined by the FDA).
The FDA, for its part, undertakes to provide a response within 45 days:
- the application is rejected because it does not meet the eligibility criteria,
- or it is accepted, and the FDA decides (without commitment on its part) on the adequacy of the proposed measures.
FEBRUARY 13, 2019_AUSTRALIA (TGA)
The TGA is seeking feedback on how software, including Software as a Medical Device, is regulated in Australia.
This consultation closes on 31 March 2019.
february 11, 2019_Hong KONG (mdco)
The regulatory systems for IVD and medical devices is currently voluntary in Hong Kong and now open all but and Class A IVD devices Class I medical devices. Previously only Class D (high risk) IVD devices were include under the Medical Device Administrative Control System (MDACS).
A copy of the Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices (GN-06E (2019) can be found on the Hong Kong page of the Asia Actual web site here.
Manufacturers typically participate in the voluntary system to:
gain a sales advantage as the Hospital Authority requires or gives preference to registered devices in public hospital purchasing decisions and
avoid confusion and delays that will come when the system becomes mandatory. To date more than 5,000 devices have been registered by the MDCO under the voluntary system.
FEBRUARY 11, 2019_EUROPE (gmed)
Bilan de l’interprétation et de l’application du RDM par le GMED (Corinne Delorme)
FEBRUARY 11, 2019_AUSTRALIA (TGA)
februarY 8, 2019_INDIA (CDSCO)
India requires more new devices to be registered under new medical devices rules, 2017
fEBRUARY 8, 2019_USA (FDA)
Intent to Exempt Certain Unclassified Medical Devices from Premarket Notification Requirements - Guidance for Industry and FDA Staff
The goal of this document is to outline FDA’s intent to propose exempting the unclassified medical devices listed in the guidance from premarket notification requirements. FDA does not intend to exempt these devices from other statutory and regulatory requirements, including, but not limited to: registration and listing (21 CFR part 807); labeling (21 CFR part 801); good manufacturing practice requirements as set forth in the Quality System regulation (21 CFR part 820); and Medical Device Reporting requirements (21 CFR part 803). It is not FDA’s intent to exempt any combination products that may fall within the product codes subject to this guidance. Also, single-entity products containing an antimicrobial agent are not within the scope of this guidance.
FEBRUARY 8, 2019_EUROPE (EUROPEAN COMMISSION)
The recently launched Medical Devices section on the European Commission's website was revamped to help smooth the transition to 2 new Regulations on medical devices and in vitro medical devices. The portal presents the new regulatory requirements in various sections targeted at impacted actors (manufacturers, importers, health institutions, authorities in non-EU countries and others).
​ec.europa.eu/growth/sectors/medical-devices_en​
FEBRUARY 7, 2019_INTERNATIONAL
The World Health Organization (WHO) reported recent progress toward the development of its international nomenclature for medical devices, known as the International Classification of Medical Devices (ICMD).
An example site to showcase ICMD is now available for browsing.
fEBRUARY 6, 2019_INDIA (CSDCO)
february 4, 2019_USA (FDA)
The Least Burdensome Provisions: Concept and Principles - Guidance for Industry and FDA Staff
​The least burdensome concept and this guidance apply to all products that meet the statutory definition of a device, including device constituent parts of combination products. The policy in this guidance applies to all activities (including premarket and postmarket actions) pertaining to the regulation of medical devices.
FEBRUARY 1, 2019_EUROPE (EUROPEAN COMMISSION)
Solution for adhesive bandage removal
Pill organiser boxes
FEBRUARY 1, 2019_CHINA (nmpa)
China rolls out secure mechanism for medical device review
In an effort to bolster the confidentiality of submissions to its medical device review process, the Chinese government in January 2019 put in place a document registration system applicants may use while seeking approval for their products.
The system is entirely voluntary, but authorities say it promises to make it easier for medical device manufacturers to file the technical materials needed to gain market approval from the Chinese government without concern that sensitive information could be seen by competitors.
Under the system, applicants would file their submissions in Device Master Files, or DMFs. Using both hard copies of submissions and the online filing system, applicants will be able to share technical information with NMPA reviewers in a more confidential manner. All DMF materials must be signed and translated into Chinese.
China institutes new medical device label requirements
Starting January 1, China began requiring detailed labelling and descriptions in Chinese on most medical device products sold in the country.
The new regulations from China’s National Medical Products Administration apply to all Class I, Class II, and Class III device manufactured after January 1.
The regulations mandate using simplified Chinese characters for the device name and descriptions and ensuring that label descriptions correspond precisely to the description on the product registration.
The new guidelines announced in late December by China’s National Medical Products Administration (NMPA) are intended to standardize its approach to the inspection of foreign manufacturing facilities.
The inspections will be performed in accordance with NMPA risk assessments and are designed to ensure the reliability and safety of devices approved or intended for marketing in China.
FEBRUARY 1, 2019_EUROPE
Europe – Another Reason to Update Your Biocompatibility Approach: EU MDRs
​Documentation expectations are changing. “Documentation needs to provide rationale for chemistry testing and why biological endpoints are not a risk; in the past, it used to be acceptable to submit a binder of tests”. “Now, when it comes to defending a device or family, the whole story needs to be documented including family descriptions, biocompatibility history, testing, evaluations, and conclusions by experts.
JANUARY 29, 2019_UK (BSI)
Urgent BREXIT Implications for Market Access - 60 Days Out from 29 March 2019
The Competent Authorities advise:
a) As of 30 March 2019, the UK will become a third country and the CE certificates will lose their validity.
b) However, very importantly, once CE certificates lose their validity post 29 March, they will not be able to be transferred or migrated to an EU NB. Products will lose market access, and a new conformity assessment will be required.
c) Cut off for the product will be based on whether the product is considered as having been ‘placed on the market’. This is not the regulatory definition but the more traditional definition used for product recall or vigilance. The product will be considered ‘placed on the market’ if before 30 March it is physically manufactured and shipped within the supply chain, for example, in a distribution warehouse (within an EU 27 member state) or the end user Hospital/Clinic etc. Product stored at the manufacturer's facility will not be deemed as having been placed on the market.
BSI strongly recommends manufacturers migrate their existing BSI UK NB (0086) CE certificates to BSI NL NB (2797) as a matter of urgency.
Request the “Migration Pack” details from the following email address > CEcert2NLNB@bsigroup.com
JANUARY 25, 2019_USA (FDA)
JANUARY 24, 2019_HONG KONG (MDCO)
The Medical Device Control Office (MDCO) will continue the trial to study the feasibility for Local Responsible Persons (LRP) to demonstrate that their medical devices conform to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) by presenting valid marketing approvals obtained from the National Medical Products Administration (formerly known as China Food and Drug Administration), as satisfying the conformity assessment requirements of the MDACS. The trial will last until 31 December 2019 for a limited number of listing applications of Class II/III/IV general medical devices.
JANUARY 23, 2019_HONG KONG (MDCO)
january 22, 2019_FRANCE (ministere de la sante)
The Ministry of Health announces its willingness to anticipate measures to strengthen the marketing and post-market surveillance of medical devices linked to the new EU regulation.
3 main axes:
Strengthen the assessment and supervision of poses practices for medical devices, especially for those most at risk
Ensure the traceability of implantable medical devices in healthcare facilities to facilitate the transmission of even weak signals of medical device vigilance
To evolve the database (Transparence Santé) and extend the current requirements for transparency and the link of interest
JANUARY 22, 2019_USA (FDA)
Publication of the guidance "Safety and Performance Based Pathway"
​There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional; Special; and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process. The Safety and Performance Based Pathway is an expansion of the concept of the Abbreviated 510(k) pathway for certain, well understood device types.
JANUARY 21, 2019_EUROPE (BSI)
BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR).
The new NB designation—the first-of-its-kind to be listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database—comes months before the timeline the Notified Bodies Operations Group had estimated in 2017 guidance for NB designation and notification.
The scope of BSI UK’s new MDR designation ranges from medical devices incorporating medicinal substances or nanomaterial to class III custom-made implantable devices, according to NANDO. BSI’s designation under the EU’s in vitro diagnostic regulations (IVDR) is reportedly set for upcoming months.
JANUARY 17, 2019_BREXIT
Ten key changes are summarised below if the draft statutory instrument (SI) is approved by the UK Parliament:
"Importers": The definition of "importer" in the Consumer Protection Act (the "CPA") will refer to importers of products into the UK, rather than into the EU. This means that importers of products into other EU countries will no longer fall within the scope of the CPA.
"Producers": The definition of "producer" in the General Product Safety Regulations ("GPSR") will similarly be limited to individuals established in the UK, rather than in an EU member state.
"Placing on the market": The definitions of "placing on the market" and "making available on the market" in the Market Surveillance Regulation ("MSR") will refer only to the UK market.
"Authorised representatives": Under the MSR, "authorised representatives" will be required to be based in the UK if they are appointed post-Brexit, although they will be permitted to be based in any EEA state if they were mandated pre-Brexit and have a continuing mandate.
Meaning of "defect": The defence to a claim under the CPA that a product "defect" is a direct result of compliance with any UK enactment or EU obligation will be restricted to UK enactments and retained EU obligations only.
Standards: For the purpose of establishing a presumption of conformity under the GPSR, the Secretary of State will now be responsible for publishing UK standards, as standards published in the Official Journal of the EU will no longer be relevant. There is currently no indication of where and when these standards will be published.
Guidelines: The Secretary of State will also take over responsibility from the European Commission in publishing guidelines on product safety assessments in the UK.
New database: The GPSR will impose an obligation on the Secretary of State to establish and operate a database containing information relating to market surveillance and product safety so that, when required, enforcement authorities can notify the Secretary of State of any measures taken in relation to unsafe products.
No RAPEX: The provisions on notifying the European Commission through the RAPEX system will no longer apply.
New UK Marking: CE marking will be replaced by a new type of marking in the UK, which has been named "UK marking". The prescribed form of the new UK marking will be published on the gov.uk website by the Secretary of State prior to the day of Brexit.
JANUARY 17, 2019_EUROPE
The analyse shows that within the Team-NB ones which submitted their applications
4 of the members have already had the Joint audit, and are now in the process of addressing the observations,
4 of the members have already submitted their application and
1 will submit it later;
And within the non-members which submitted their applications
1 has the completeness of his application checked by the Competent Authority (CA)
2 have submitted their application and
1 will submit it later.
JANUARY 16, 2019_EUROPE
New Manufacturer Incident Report form - as from January 2019
JANUARY9, 2019_CHINA (NMPA)
NMPA has published draft guidance (link in Chinese) on the voluntary filing process for Device Master Files, or DMFs. Through the process, DMF owners will be able to share technical information with NMPA reviewers without disclosing this information to applicants during device registrations, according to Emergo by UL consultants in Hong Kong.
JANUARY 8, 2019_EUROPE
January 7, 2019_Australia (TGA)
3 documents on consultation (End on 18 February 2019):
Changes to a number of definitions and the scope of the medical device regulatory framework in Australia
https://www.tga.gov.au/sites/default/files/consultation-changes-number-definitions-and-scope-medical-device-regulatory-framework-australia.pdf
​Potential reclassification of active medical devices for diagnosis and patient therapy ​
​The EU Regulation on medical devices (2017/745) (EU MD Regulation) introduced several amendments to the classification rules effectively reclassifying some categories of medical devices to higher risk classes.Having regard to the amendments implemented by the EU MD Regulation, TGA is proposing to introduce a new classification rule, which is appropriately tailored for the Australian regulatory context, for active medical devices with an integrated or incorporated diagnostic function that significantly determines patient management.
While the new classification rule in the EU more appropriately reflects the intended use and the risk of medical devices, this consultation considers the extent to which a similar approach will be appropriate in the Australian regulatory context, while also achieving high standards of quality, safety and performance.
https://www.tga.gov.au/sites/default/files/consultation-potential-reclassification-active-medical-devices-diagnosis-and-patient-therapy.pdf
​Demand is growing for improved traceability of medical devices in the supply chain. There is now worldwide recognition that, in the interests of patient safety and improved industry outcomes, the ability to unambiguously identify medical devices is essential. The development and implementation of the Unique Device Identification System (the UDI System) is widely acknowledged by the industry and regulators as an effective mean of ensuring timely access to complete, accurate and consistent information about medical devices.The TGA is exploring the feasibility of introducing the UDI System in Australia, including options for development of the UDI database (AusUDID), and seek your views on the proposed regulatory changes that would facilitate the adoption of the internationally harmonised principles for introduction of the UDI system in Australia.
​https://www.tga.gov.au/sites/default/files/consultation-proposal-introduce-unique-device-identification-udi-system-medical-devices-australia.pdf
JANUARY 1, 2019_SWITZERLAND (SWISSMEDIC)
Notification for placing a medical device on the market
According to the Ordinance of the Swiss Agency for Therapeutic Products on its fees (GebV-Swissmedic, SR 812.214.5), as of 1 Jan. 2019, notifications for placing medical devices on the market according to Art. 6 of the Medical Devices Ordinance (MedDO, SR 812.213) will attract a fee of CHF 300.- per notification.
BW530_00_001e_FO Notification in accordance with Art. 6 of the MedDO for classical medical devices, custom-made medical devices and systems or procedure packs (PDF, 1 MB, 01.01.2019)
January 1, 2019_MALAYSIA (MDA)
Malaysia refines requirements for labeling medical devices
In November 2018, Malaysia’s Medical Device Authority released the Third Edition of its Guidance Documents on Requirements for Medical Device Labeling. Major changes include:
Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices shall be labeled in English.
Internationally recognized symbols and codes may be employed on labels. But if the meaning of a symbol is not obvious, is not understandable to the general user or has been newly introduced, an explanation must be provided.
Labels must contain the following identifying characteristics of the device:
Batch code, lot number or serial number
Shelf life of the device in both unopened and opened states
Optimal conditions for storage