120th
Periodic meetings to exchange opinions
on approval reviews and safetymeasures for medical devices and invitro diagnostics
September 1st 2022
American Medical Device and IVD Industries Association (AMDD)
Advanced treatments Technology Industries Association (AdvAMeD)
European Business Council (EBC) Medical Devices and IVD Committee

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Details of today◼ Introduction◼ Issues and requests concerning program medical devices◼ Development of an environment to accelerate the creation ofevidence◼ Efforts for International Harmonization and ReferenceCountryization
1. Mutual utilization of various regulations and investigation results
2. Toward further rationalization and international harmonization of the QMS inspection
system
3. In order to utilize the examination results in Japan overseas (explanation of cases)

3Introduction
I would like to express my appreciation for the flexible and prompt response by the government that there has been nodelay in pharmaceutical administration such as approval reviews during the novel coronavirus outbreak since the year
before last.
In the " Formulation of a Collaborative Plan for Optimizing Medical Device Regulations and Reviews, " AMDD / AdvAMeD /EBC has taken measures to promote the development and market introduction of innovative medical devices. Thesemeasures include continuing discussions on a wide range of improvements and reform items ; DASH for sAMD within theMinistry of Health, Labour and Welfare PMDA strengthening of the Screening Department system, unification ofconsultation services, establishment of the IDATEN system, etc. strengthening of the system of the Ministry of Health,Labour and Welfare by the DASH for SaMD DASH for the Ministry of Health, Labour and Welfare for the Ministry of Health,Labour and Welfare for the Ministry◼ Expectations for the Increased Value of Pharmaceutical Approval in Japan on a Global Basis➢ There have been cases in which approval in Japan precedes FDA and CE marks due to theacceleration of PMDA review and the introduction of MDR. As a result, the number of cases in which
Japanese approval is referred to in the examination of other countries is increasing. However, practicalproblems have arisen to allow Japanese approval to be used in other countries. (One of the specificrequests is explained in Slide 8 below)➢ The expansion and deepening of Asian leadership, especially the strengthening of bilateral relations
with the People's Republic of China, will greatly benefit not only Japanese companies but also AMDD /AdvAMeD / EBC member companies.

34Issues and requests related to program medical devices◼

Establishment of a review system according to the characteristics of programmed medical devices➢

Through the DASH for sAMD, the Ministry of Health, Labour and Welfare (MHLW) and the PMDA (ScreeningDepartment) have been strengthened, consultation services have been unified, and the IDATEN system has been
improved.
➢ However, the Company recognizes that there are still issues to be addressed in " establishing a review system
based on the characteristics of programmed medical devices. "- Application of examination requirements for hardware as they are (affecting the handling of partial changes)- Necessity of premarketing clinical evaluation (inconsistent with development speed)➢ The Government of Japan requests the Government of the United States to establish and ensure the operation of asystem that reflects its characteristics.
- New review of the change system and operation that should be applied to program medical devices- Establishment of a system that assumes, for example, the use of RWD (not clinical trial)- Establishment of a new system to provisionally approve, for example, safety assurance + validity estimation◼

Cybersecurity➢In addition to the WORKING Group of the Federation of Medical Devices and Manufacturers (PMSB), discussions
have been held in various places toward legislation in Japan based on the IMDRF guidance. A notification isscheduled to be issued within this fiscal year and to take effect next summer.
The Government of Japan requests the Government of the United States to continue discussions with the industryand ensure the establishment and operation of an internationally harmonized system (without any uniquerequirements of Japan).

➢5Development of an environment to accelerate the creation of evidence◼

◼

Use of real-world data for pharmaceutical applications➢There have been cases of using registry data in foreign countries for approval applications. When using overseas
registry data for approval applications in Japan, there are concerns about differences in the way of thinking
between Japan and the United States regarding the reliability of databases and handling of personal information.

➢DBs led by academic societies have problems such as patient consent, access restrictions for companies, andrestrictions on acquired information, and companies have not made progress in the development of newproducts, improvement of algorithms, and utilization in pharmaceutical applications.

Promotion of utilization of secondary data acquired by medical data including AI➢◼

It is necessary to discuss the interpretation of the operation of the Personal Information Protection Law(anonymization / kana processing of data), Next Generation Medical Infrastructure Act, Information Security
Guidance and Ethics Guidelines.

Standardization (integration) of regulations related to clinical research (GCP, clinical researchmethod, ethical guidelines)➢I look forward to the commencement of discussions on the current status (complexity) of the three regulations
concerning clinical research in order to improve the environment for promoting development.

56Efforts for International Harmonization and Reference Countryization
1 Mutual use of various regulations and investigation results◼

MDSRP(Medical Device Single Review Program) Promotion of Discussions➢ It is expected to be applied to high-class products in the future.

◼

Continuous international harmonization of regulations (such as ISO, QMS, GCP ) is essential for
rapid adoption of medical devices.
➢ ISO10993-1 revision and the revision of the Basic Concept of Biological Safety Assessment (Notification No.
030 1 20 of the Pharmaceutical and Food Safety Bureau) are aligned.
➢ The Government of Japan requests the Government of the United States to continue careful consideration
including the operational aspects so that the biological safety evaluation data conducted in the United Statesand Europe can be used for the application in Japan.

◼

Mutual acceptance among Japan, the United States, and Europe of the results of GCP
compliance inspections based on global clinical trials, etc.
➢◼

GOJ requests USG to consider the possibility of an MRA (Mutual Recognition Agreement) between Japanand the US and between Japan and the EU.

Scope and reporting methods of foreign case reports and research reports➢

Based on international consistency with overseas reporting systems, I expect discussions on a system thatcan provide information more quickly and contributes to medical practice in Japan.

International Coordination of Regulatory Operation to Eliminate Development Lag
Requests for mutual utilization of regulations for further acceleration of examination inthe future6

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Efforts for International Harmonization and Reference Countryization
2. Toward further rationalization and international coordination of the QMS inspection system◼

Full-scale introduction of MDSAP in fiscal 2022 and expectations for the future➢

Depending on the business model of manufacturing medical devices in Japan, exporting medical devices
overseas, and importing medical devices from overseas, there are differences in each marketing authorization
holder's views on MDSAP. MDSAP is one of the options, but in order to encourage more companies toparticipate in it in the future, it is essential to publicize its advantages.

◼

QMS Opinion Exchange Meeting➢➢

This is a meaningful and valuable opportunity for frank exchange of opinions with the government.
Health, Labour and Welfare Scientific Research QMS Group " QMS Systems in Light of InternationalHarmonization " took up topics such as " Issues of the current QMS inspection system " and " Issues comparedwith other countries ' QMS inspection systems " as topics related to the " QMS Inspection System in Light ofInternational Harmonization " which were discussed in the QMS Group. Positive discussions took place. (June2022)◼

Review of a QMS compliance inspection system based on international harmonization➢Expectations for the results of activities by the Health, Labour and Welfare Science Research QMS Group (20212022) and with industry Please continue discussions after the meeting.
In the future, I expect that the concept itself from QMS investigation for each product group to QMS investigationfor each company, for example will be reviewed and considered.

➢From QMS inspections for individual products to QMS inspections for individualcompanies

Efforts for International Harmonization and Reference Countryization
3. In order to utilize the examination results in Japan overseas (explanation of cases)◼ It is requested that the brand name (in English) at the import destination be entered in the remarks
column of the marketing approval / certification.
➢The procedures for obtaining a certificate to a foreign government for medical devices that have obtained
manufacturing / marketing approval / certification for imported products are complex and rapid.
✓Since the English product name cannot be confirmed on the manufacturing / marketing approval /certification document, the manufacturing / marketing approval / certification details certificate (Form 5-2))

issued by OMETA (Overseas Medical Device Technical Cooperation Association) When it is manufactured in acountry other than Japan imported products are required to submit a notification of medical devices to beexported. However, it is necessary to submit a notification of medical devices to be exported.
✓Since it is not possible to obtain a certificate to a foreign government only with a Japanese approval /certification document, it is necessary to include the English brand name on the approval document. In thecase of cosmetics it is possible to specify brand name at the importer in the " remarks " column. )◼ Reference information : Handling of Marketing Approval Certificates in Japan in Foreign Countries➢A foreign government certificate in English that is issued by the Ministry of Health, Labour and Welfare as theissuing authority in a country to which the simplified examination is applied is treated in the same manner as Free
Sales Certificate (FSC) or FDA Certificate to Foreign Government ( CFG ) of CE.

➢In Singapore and Thailand, certificates addressed to foreign governments of two of the five major countries arerequired .

2023/1/18

Overseas request for new operation due to simplified examination forapproval in Japan89(Reference data)

Examples of various certifications described on page 8

Certificate of contents of marketing
approval / certification (MHLW Form 5-2)

Certificate to Foreign Government (MHLW)

Certificate to ForeignGovernment(FDA)