EPP Medical Device Regulatory

Country ReportJapan International Corporation of Welfare Services (JICWELS)EPP Medical Device Regulatory

MALAYSIAMEDICAL DEVICE AUTHORITY, Ministry of Health Malaysia ● Level 5, Menara Prisma, No 26,Persiaran Perdana, Precinct 3, 62675 Putrajaya● http://www.mdb.gov.my ●mdb@mdb.gov.my INTRODUCTION: OVERVIEW OF REGULATORY FRAMEWORK SCOPE OF REGULATION RISK-BASED CLASSIFICATION & REGULATORY CONTROL CONFORMITY ASSESSMENT REGISTRATION OF MEDICAL DEVICES
 LICENSING OF ESTABLISHMENTS
 POST MARKET ACTIVITIES1BACKGROUND• Cabinet approved the policy on thedevelopment and implementation of medicaldevice regulation in 2005

• Why regulate medical devices?

– To address public health & safety issues– To facilitate medical device trade & industry• global market• growth of the industry

Medical Device Control Division
MINISTRY OF HEALTH MALAYSIASTRUCTURE OF THE REGULATORYSYSTEM
MEDICAL DEVICE REGULATORY SYSTEMMEDICAL DEVICE ACT2012 (ACT 737).. gives powers to…

MINISTER OF HEALTHMEDICAL DEVICE AUTHORITY

Chief Executive, officers, servants
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

2.. gives powers to…

MEDICAL DEVICEAUTHORITY ACT 2012(ACT 738)

CABsUsers
Establishments•Manufacturers•ARs•Distributors•Importers

STRUCTURE OF THE REGULATORYSYSTEM• Medical Device Act 2012 (Act 737)

– To regulate medical devices, the industry and to providefor matters thereto.

• Medical Device Authority Act 2012 (Act 738)
– To provide for the establishment of the Medical Device
Authority with powers to control and regulate medicaldevice, its industries and activities, and to enforce themedical device laws, and for related matters.

Medical Device Control Division
MINISTRY OF HEALTH MALAYSIASTRUCTURE OF THE REGULATORYSYSTEM
MEDICAL DEVICEAUTHORITY (MDA)

Functions of MDA• To implement, enforce, consider andrecommend reform to the medical device laws
• To perform the following- to regulate all matters- to encourage & promote thedevelopment- to provide consultancy & advisory
service and any other services
in relation to medical device, its industries
and activities• To utilize property of the Authority in suchmanner as the Authority may think expedient• To impose fees or charges for services
rendered

A body corporate with thefollowing members- DG of Health as the Chairman- Chief Executive of the MDA- a representative of Min of Finance- a representative of Min of Health- not more than five persons
appointed by the Minister, who haveexpertise and experience in medical
device matters

Committees appointed by MDA- to assist it in the performance of thefunctions of the Authority
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA3OVERVIEW OF THE
REGULATORY FRAMEWORK
PRE-MARKETPRE-MARKET ASSESSMENT
Manufacturers of medical
devices shall • ensure their products
conform to EPSP
• establish appropriate quality
system for manufacturing
their products• collect evidence ofconformity

CAB verifies evidence ofconformity

PLACEMENT ONMARKETMEDICAL DEVICEREGISTRATION• Manufacturers (or authorizedrepresentatives) apply toregister medical devices &establishment license
ESTABLISHMENT LICENSING
Importers/distributors shall • ensure compliance to GDPMD &advertising requirements• apply for establishment license
to import/distribute medicaldevices

POST-MARKETSURVEILLANCE & VIGILANCE
Establishments shall • monitor safety & performanceof products• carry out post-market
obligations, eg complainthandling, FSCA, recall

USAGE & MAINTENANCE• Users shall use, maintain &dispose off medical devices
appropriately

MDA issues licenses, registers medical devices and monitors compliance torequirements & takes appropriate actions in accordance with the provisions of the law
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIASCOPE OF THE REGULATION
Section 2 of Act 737"establishment" means:(a) a person who is either a manufacturer, importer, ordistributor who is responsible for placing any medical
device in the market but does not include a retailer; and(b) an authorized representative appointed by amanufacturer having a principal place of business outside
Malaysia,
and such person and authorized representative being:(A) a person domiciled or resident in Malaysia; or(B) a firm or company constituted under the laws ofMalaysia, and carrying on business or practice principallyin Malaysia
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA4SCOPE OF THE REGULATION
Section 2 of Act 737"manufacturer" means:(a) a person who is responsible for:(i) the design, production, fabrication, assembly, processing, packaging and labelling of a
medical device whether or not it is the person, or a subcontractor acting on the person’sbehalf, who carries out these operations; and(ii) assigning to the finished medical device under his own name, its intended purpose andensuring the finished product meets the regulatory requirement; or(b) any other person who:(i) assembles, packages, processes, fully refurbishes, reprocesses or labels one or moreready-made medical devices; and(ii) assigning to the ready-made medical device under his own name, its intended purposeand ensuring the finished product meets the regulatory requirement,
but shall not include the following persons:(A) any person who assembles or adapts medical devices in the market that are intended
for individual patients; and(B) any person who assembles, packages or adapts medical devices in relation to which theassembling, packaging or adaptation does not change the purpose intended for the medicaldevices
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIASCOPE OF THE REGULATION
Responsible party

Regulated activities/responsibilities

Local manufacturer• To ensure products meet EPSP and are manufactured in accordancewith ISO 13485• To apply for product registration• To monitor safety & performance and to take corrective actions on
problems related to products in the market

Authorized
representative

To act on behalf of foreign manufacturers with regard to themanufacturer’s responsibilities under the Malaysian laws

ImporterDistributor

To ensure compliance with requirements of good distribution practice for
medical device (GDPMD), eg cleanliness & suitability of premises, storage& stock handling, traceability, product complaints, etc

CAB

To verify evidence of conformity to EPSP, ISO 13485, GDPMD

Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

5RISK-BASED CLASSIFICATION &REGULATORY CONTROL
Section 3 of Act 737
Classification of medical device(1) A medical device shall be classified by an establishment
based on the level of risk it poses, its intended use and thevulnerability of the human body in accordance with theprescribed manner.
(2) In the event of any dispute between an establishment and aconformity assessment body over a classification of a medicaldevice, the matter shall be referred to the Authority, in themanner and within such period as may be specified by theAuthority, for its decision.
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

RISK-BASED CLASSIFICATION &REGULATORY CONTROL• A classification of medical devices based on risk associated with the vulnerability of thehuman body, the technical design and the manufacture of the medical device
 It uses a set of classification rules
based on:intended use
duration of use (transient, short-termand long-term) part of human body (non-invasive orinvasive with respect to body orifices,
surgically invasive interventions,central circulatory system, central
nervous system)
ClassRisk Level

Device examples

ALow

Simple surgical instruments, tongue
depressor, liquid-in-glass thermometer,
examination light, simple wound dressing,oxygen mask, stethoscopes, walking aids

B

LowModerate

Hypodermic needles, suction equipment,
anesthetic breathing circuits, aspirator,
external bone growth simulators, hearing
aids, hydrogel dressings, patient controlledpain relief, phototherapy unit, x-ray films

CHighModerate

Lung ventilator, orthopedic implants, baby
incubator, blood oxygenator, blood bag,
contact lens disinfecting/cleaning products,
deep wound dressing, defibrillator,
radiological therapy equipment, ventilator

DHighPacemakers and their leads, implantabledefibrillators, implantable infusion pumps,
heart valves, inter-uterine contraceptive
devices, neurological catheters, vascular
prostheses, stents

DC

B

A

Regulatory control

RISK

Device risk/class
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

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CONFORMITY ASSESSMENT
Section 4 of Act 737
Manufacturer’s obligations
A manufacturer shall ensure that a medical device:(a) conforms to the prescribed essential principles of safety andperformance;(b) is manufactured in accordance with good manufacturing
practice and any written directive issued by the Authority; and(c) is labelled, packaged and marked in accordance with theprescribed manner
Manufacturers shall conduct conformity assessment to provide
objective evidence of safety and performance of a medical device
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIACONFORMITY ASSESSMENT
Section 10 of Act 737
Conformity assessment body(1) A conformity assessment body shall be a body registered under this Act tocarry out conformity assessment of a medical device to be registered under thisAct.
(2) The person who is in charge of and has overall control over a conformity
assessment body shall be a Malaysian citizen.
(3) A conformity assessment body shall be independent and shall not have, acquireor hold any interest, directly or indirectly, in relation to:(a) any medical device under its assessment;(b) any shares in the establishment whose medical device is assessed by it; or(c) any related company of the establishment whose medical device is assessed byit.
(4) A conformity assessment body shall not disclose any information received
during the conformity assessment procedures carried out on any medical device.
(5) A conformity assessment body shall be audited by the Authority from time totime as may be deemed necessary by the Authority.
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

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CONFORMITY ASSESSMENT
Elements of CA
QMS (ISO 13485 or equivalent,GDPMD)
Post-market surveillance system
Summary technicaldocumentation (CSDT)Registration of medical device &licensing of establishment

What is conformity
assessment (CA)?
Systematic examination ofevidence generated andprocedures undertaken by themanufacturer under therequirements established by theRegulatory Authority to determinethat a medical device is safe andperforms as intended by themanufacturer and, therefore,
conforms to the Essential
Principles of Safety andPerformance for Medical Devices

What To Look For In CA?
Objective evidence forconformance to Essential
Principles of Safety &Performance of Medical Device –6 general principles
11 design and manufacturing
principles

Medical Device Control Division
MINISTRY OF HEALTH MALAYSIACONFORMITY ASSESSMENTCA PROCESS & PARTIES INVOLVED
Conformity assessment
is primarily theresponsibility of the
medical device
manufacturer.
However, it is done in
the context of theestablished regulatory
requirements and boththe processes andconclusions are subject
by the Regulatory
Authority
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

Manufacturer
conducts CA on;(i) QMS & PMS(ii) Product safety& performance(summary tech doc& DoC

CAB reviews
evidence ofconformity
Authority reviews& registers product& licenses
establishment

What is a CAB?
 A body authorized by the Authority to perform
specified CA activities to determine whether therelevant requirements in technical regulations or
standards are fulfilled
 CAB is independent of the organization that provides
the product and is not a user of the product (3rd party)
 Authority will monitor the performance of the CAB
and, if necessary, withdraw authorization

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LICENSING OF ESTABLISHMENTS
 Establishment means aperson/organization who iseither a manufacturer,authorized representative (forforeign manufacturer), importer
or distributor of medical
devices, but does not include aretailer Different type of establishment
has different roles &responsibilities – different setof control
 Establishment must possess
valid license to carry out
activities related to medical
devices in Malaysia

Foreignmanufacturer

Importer
Authorized
representative

Local
manufacturer

Distributor

Distributor

Imported device

Locally-made device

Relationship between different
establishments

Medical Device Control Division
MINISTRY OF HEALTH MALAYSIAPOST-MARKET SURVEILLANCE & VIGILANCE
37. Distribution records(1) …….maintain a distribution record in respect of each medical device manufactured, …...
(2) …..contain information as prescribed by the Minister.
(3) …….provide the distribution records to the Authority upon request.
38. Post-market surveillance and vigilance(1) ……monitor the safety and performance of the medical device ….and put in place a post-market
surveillance system …….
(2) ……report of adverse incident …. is properly recorded and fully evaluated.
39. Complaint handling……establish and implement documented procedures and maintain records of reported problems orcomplaints
40. Mandatory problem reporting(1) ……report to the Authority any incident that …..:(a) ….the failure of the medical device or a deterioration in effectiveness, inadequacy in labelling or
instructions for use ….thirty days from the discovery;(b) has led to the death or serious deterioration in the state of health of a patient, user or other person, or
could do so were the incident to recur ….ten days from the discovery; or(c) is a serious threat to public health …..forty-eight hours from the discovery.
(2) Any person who contravenes subsection (1) commits an offence ….

Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

9POST-MARKET SURVEILLANCE & VIGILANCE
41. Field corrective action…..undertake corrective or preventive action in relation to a medical device
imported and placed in the market which may include:(a) the return of the medical device to the establishment;(b) modification of the medical device;(c) exchange of the medical device;(d) destruction of the medical device; or(e) specific advice on the use of the medical device.
42. Recall(1) ….may recall any defective medical device at any time.
(2) …..on or before undertaking a recall ….., provide information as may bespecified …...
(3) ….as soon as possible after the completion of a recall, report to …..action
taken to prevent a recurrence of the problem.
(4) ….Authority may order the establishment to recall any medical device at anytime due to patient safety and public health.
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA….Thank you for yourattention
Medical Device Control Division
MINISTRY OF HEALTH MALAYSIA

10Issues & Problems in
Implementing of Medical
Device Regulatory

EPP Medical Device Regulatory Program

13/3/2015

Comparison of Regulatory Framework
Between Japan and Malaysia
REQUIREMENTJAPAN

MALAYSIA

ACT/ LAW

PMD Act , Medical Care Act

Medical Device Act 2012 (Act737)

AUTHORITY

PMDA/ MHLW, Local
Government

MDA, Local Government

NOMENCLATURE

JMDN/ GHTF

Global Medical Device
Nomenclature (GMDN)/ GHTF

TECHNICAL DOCUMENTATION

STED

CSDT

CLASSIFICATION

III, IV : Approval by MHLW

A, B, C & D : Approval by MDA

CERTIFICATION

II : 3rd party certification bodyIII, IV approved by PMDA

Establishment & Conformity
Assessment : CAB

POST MARKET

Adverse Event (AE) submit to
PMDA/ MHLW

Adverse Event (AE) submit to
MDA

Good Vigilance Practice (GVP)

Post Market Surveillance (PMS)

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Issues/ Problems – Pre Market
 Licensing
Tendering Agent

Background : Activities of tendering agent in Malaysia is just to prepare
the invoice to user/ medical institution and did not keep any inventories(no warehouse). The issue is currently they are not being licensed since
they are not fall under any establishment’s definition. If any incident
happen to the device, the action can’t be taken on them since they are
not abide under our jurisdiction.

Propose solution : They must have an establishment license and GDPMD
certificate. However, only certain requirement of GDPMD need to becomplied related to the business activities.
EPP Medical Device Regulatory Program

3/3/2015

3Issues/ Problems – Pre Market (2) Medical Device Registration
Reviewing Process of Registration ProductBackground : By the month of February 2015, Malaysia will start the reviewing medical device product inthe data base system. The reviewing time need to be efficient and numbers of application need to beincreased within certain time of period.
Propose solution : Abridge process
We proposed to have abridge process to expedite reviewing process. Abridge process is to facilitate theregistration of medical device in the timely manner. This include to recognise the certification ofapproval in the five founding members. As for Japan, Malaysia shall accept the certification standard forclass II under the RCBs and for class III and IV with approval standard under the MHLW.
The checklist for EP’s enable the applicant to understand what are the requirements for medical device
approval/certification and how the conformity to each requirement can be shown.
The EP checklist is prepared in Technical Requirement.
- 422 EP’s checklist for 920 class II (GHTF class B) Medical Device- 29 EP’s checklist for 61 Class III (GHTF Class C ) Medical Device- 8 EP’s checklist for 21 Class IV (GHTF Class D ) Medical Device
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Issues/ Problems – Pre Market (3)Quality Review

Background : The quality of reviewer is differ from one to another. Inorder to have good understanding about the product, the quality ofreviewer need to be upgraded.
Propose solution : In keeping up with our vision of having a system ofquality review of medical devices, we devise strategies of the following :-Having a close relationships with academician institute such asuniversities and medical institutions (study in the universities andexchange information).

-Role of associations in Malaysia such as FMM, MMDA, CFDA should be
more active in investigate, study and policy proposal for the bettermedical care and medical devices.

EPP Medical Device Regulatory Program

3/3/2015

5Issues/ Problems – Pre Market (4)Change Notification

Background : After medical device has been approved, anychanges related to the device either minor or major need tobe notified to the Authority. Currently, we are in the midstof determine criteria on minor or major changes.
Propose solution :To develop a criteria to determine minor or major changes ofmedical device registration.

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Issues/ Problems – Post Market (1)Complaint Handling

Background : Complaint of medical device must be reported to theAuthority. The issue is to determine the status of repeatablecomplaint of device (trending) whether it can be registered orotherwise.
Propose solution :-To develop a criteria to determine the status of repeatablecomplaint of device (trending).

-At this moment, MDA is collecting the raw data to identify thetrending of complaints. From that data, we will conduct anaudit to the establishment for better understanding.

EPP Medical Device Regulatory Program

3/3/2015

7Issues/ Problems – Post Market (2)Enforcement activities

Background : We are in the midst of developing enforcement
activities. The issue is to take action with the unregistereddevice in the market.

Propose solution : To work together with the other agencies
such as police, local government, Ministry of Domestic Tradeand Consumer Affair (MDTCA), Malaysia Communications andMultimedia Commission (MCMC) related to raiding activities.

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