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Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
1
UPDATES ON MEDICAL DEVICE REGULATORY REQUIREMENT AND
HARMONISATION OF MEDICAL DEVICES REGULATORY REQUIREMENTS IN THE
ASEAN REGION -
IR.SASIKALA DEVI MEDICAL DEVICE AUTHORITY
MINISTRY OF HEALTH MALAYSIA
MEDICAL DEVICES AUTHORITY, Ministry of Health Malaysia Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya,MALAYSIA
http://www.mdb.gov.my ● [email protected]
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
CONTENT
• UPDATES ON MEDICAL DEVICES REGULATORY SYSTEM
• BACKGROUND AMDD
• HARMONISATION OF MD REGULATORY REQUIREMENTS
• INTRODUCTION TO AMDD
• AMDD ARTICLES
• UPDATES ON AMDD
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
MEDICAL DEVICES REGULATION: REGULATORY FRAMEWORK IN MALAYSIA:
Stages of Regulatory Control throughout the life cycle of medical device
WHO Regulatory Model
MEDICAL DEVICES AUTHORITY MALAYSIA . http://www.mdb.gov.my
TIMELINE
14 June 2012 : Establishment of Medical Device Authority
30 June 2013 : Effective date of Act 737
1 July 2013 : Effective date of MDR 2012
1 July 2013 : 1 July 2014 : Transitional period for Licensing of Establishment
I July 2013- 1 July 2015 : Transitional Period for Registration of Medical Devices
MANDATORY
REGISTRATION OF
MEDICAL DEVICES
1 JULY 2015
…extended to
1 JULY 2016
Market Access and Control
Medical Device Product Control Facilitate
trade and Industry
Ensure public
health and safety
Establish. Control
Export Permit List of
Products
Int. Standards
List of Licensed Est
Harmonised Regulations
Permit Of DMD
Usage
Maint. Disposal
Product Registration
C
D
B
A
CAB
Regist Manuf.
Dist. Importer
AR
Establish. License
Advertisement QMS
Product
POST-MARKET VIGILANCE AND SURVEILLANCE SYSTEMS & ENFORCEMENT
Medical Device Act 2012 (Act 737) Objective and control
List of Registered Conformity Assessment Body (16-CAB)
REGISTRATION Medical Device
GM& IVD
NUMBER OF APPLICATION RECEIVED 23,567
TOTAL NUMBER OF MEDICAL DEVICE UNDER
EVALUATION 427,043
TOTAL NUMBER OF MEDICAL DEVICES APPROVED FOR
REGISTRATION (Include Class A) 50,728
ESTABLISHMENT LICENSE NO
APPLICATION SUBMITTED 2470
APPROVED 1663
POLICY DETAILS
2014 1 / 2014 - Establishment As Authorised Representative And
Establishment Undertaking Multiple Activities
2 / 2014 - Conformity Assessment Procedures For Medical
Device Approved By Recognised Countries
3 / 2014 - Exemption Of Medical Device From Registration
Requirements
Note:The Circular Letter will no longer effective. Please Refer
to Medical Device Exemption 2016
4 / 2014 - Medical Device For The Purpose Of Export And Transit And
Medical Device For Import/Export From/To Countries Without
Diplomatic Ties With Malaysia
5 / 2014 - Certification Of Good Manufacturing Practice (GMP)
For The Purpose Of Obtaining Establishment License
YEAR DETAILS
POLICY STATUS
2015 Advertisement of Medical Device During Transition Period Beyond Jurisdiction of
Act 737
Gazettement Of Non-Corrective Contact Lens As A Medical
Device Draft ORDER
Post Market Responsibility For Local Manufacturer / AR Who
Has Closed Their Business
Beyond Jurisdiction of
Act 737
Requirement For Registration Of Orphaned Medical Device In
Hospital Or Institutional Healthcare Facilities
Beyond Jurisdiction of
Act 737
Issuance Of Certificate Of Free Sale (CFS)/
Manufacturing Certificate (MC) Completed
Fast Track Medical Device Registration During Transition Period Dropped
2016 1 / 2016 - Refurbishment of Medical Device
2 / 2016 - Medical Device Procurement For Healthcare Institution
3 / 2016 - Change Of Ownership For Medical Device Registration
4 / 2016 - Transition Period For Medical Device Labeling
5 / 2016 - Imposition Of Charges Or Fees For Product Classification
REGULATORY &
GUIDANCE
DOCUMENTS
DETAILS
2014 1. Product Grouping First Edition October 2013
2. IVD Medical Device Classification System First Edition July 2013
3. Essential Principles of Safety & Performance of IVD Medical Device, First Edition
July 2013
4.Principles Of Conformity Assessment For In- Vitro Diagnostic (IVD) Medical
Devices First Edition July 2013
5.Common Submission Dossier Template of IVD Medical Device First Edition July
2013
6.Definition of Medical Device, First Edition March 2014
7.Essential Principles of Safety & Performance of Medical Device, First Edition March
2014
8.Common Submission Dossier Template, First Edition March 2014
9. The rules of classification for general medical devices, First Edition March 2014
2015 Good Distribution Practice for Medical Devices (GDPMD), First Revision
November 2015
2016 1. Good Refurbishment Practice of Medical Devices (GRPMD) First edition 2016
2. Guidance Document Declaration of Conformity First Edition February 2016
3. Guidance Document On Licensing for Establishment
4. Guidance Document On Requirements For Labelling Of Medical Devices
CFS NO CERTIFICATES
2008-2015 10823
NUMBER OF CERTIFICATES (AS OF JULY 2016) 713
CONSULTATION SESSION` NO ESTABLISHMENT
2013-2015 534
2016 71
AWARENESS PROGRAM NO PROGRAMS
AWARENESS PROGRAMME ON 2013-2015 21
AWARENESS PROGRAMME ON 2016
16
AWARENESS PROGRAM 2015
USER:6 ZONE
JOHOR,PERLIS,
PERAK,PUTRAJAYA,
SHAH ALAM,SABAH&
SARAWAK
INDUSTRY: 10
JOHOR,PENANG,
PUTRAJAYA, KL,
MELAKA, AWARENESS PROGRAME
2016
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
14
BACKGROUND ON AMDD
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
ASSOCIATION OF SOUTHEAST ASIAN NATIONS(ASEAN)
15
ASEAN
ASEAN is a geo political and economic organization of ten countries located in Southeast Asia which was formed on 1967
10 MEMBER STATES: Malaysia,
Philippines,
Thailand,
Indonesia,
Singapore,
Vietnam,
Brunei
Darussalam,
Lao PDR,
Cambodia,
Singapore
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
ASEAN FREE TRADE AREA (AFTA)
• In 1992, ASEAN Heads of Government declared that ASEAN Free Trade Area (AFTA) shall
be established in the region and in 1995, agreed to accelerate its implementation to the
year 2003.
• ASEAN Economic Consultative Committee,
• ASEAN Social Consultative Committee &
• ASEAN Consultative Committee on Standards and Quality (ACCSQ)
• ASEAN Consultative Committee for Standards and Quality (ACCSQ) was formed by the ASEAN Economic Minister in 1992.
− Aim of ACCSQ is to remove technical barriers to trades in order to facilitate and realize the ASEAN Free Trade Area (AFTA).
− Focus:
harmonisation of standards- technical requirements
development of MRA on conformity assessment and
development of harmonised regulatory regime
• The establishment of the ASEAN Economic Community has been accelerated from 2020
to 2015 which will create ASEAN as a single market and production base.
ASEAN HARMONIZATION
The Activities of ACCSQ is Formalizing Harmonization between all ASEAN members countries with developing technical, standard and legal aspect to implementation the harmonization of regulation
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
PRODUCT WORKING GROUP ON MEDICAL DEVICE (ACCSQ-MDPWG)
• Product Working Group on Medical Device (ACCSQ-MDPWG) was established to fast- track
integration of the medical device within ASEAN Member Economies, 2005.
• Objectives: to implement measures to facilitate the integration of medical device within
ASEAN Member Economies.
• Role and responsibilities of MDPWG
Developing a CSDT template for product approval in ASEAN
Exploring the feasibility of an abridged approval process for medical devices of approved or
benchmarked countries
Exploring the feasibility of adopting a harmonized system of placement of medical devices into
the ASEAN markets, based on a common product approval process
Formalizing of a post-marketing alert system for defective or unsafe medical devices.
Exchange of information on standards, regulations, procedures and mandatory
requirements in Member Countries related to medical devices;
Review and analyze the comparative study of regulatory regimes among Member Countries;
Identify the technical infrastructure needs and build-up mutual confidence in testing and
conformity assessment
• ASEAN MEDICAL DEVICE DIRECTIVE (AMDD) was signed on 21 November 2014
• In 2015 establishment of ASEAN Medical Devices Committee (AMDC)
Goal of creating an ASEAN Economic Community by 2015, with fast-
track integration of the 12 priority sectors
1. Agro-base product 5. Electrical 9. Health care product
( drug, traditional drug,
cosmetic and Medical
Devices)
2. Air Travel 6. Rubber base
product
10. Textiles and
apparels
3. Automotive 7. Tourism 11. Wood-based product
4. e-ASEAN 8. Fisheries 12. Logistics Services
ASEAN Economic Consultative Committee
ASEAN Social Consultative Committee
ASEAN Consultative Committee on Standards and Quality (ACCSQ)
HARMONIZATION OF
MEDICAL DEVICES
REGULATION in ASEAN
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
HARMONIZATION OF MEDICAL DEVICES REGULATION
GROUP OF HARMONIZATION
IMDRF (GLOBAL)
AHWP (ASIA)
ACCSQ (ASEAN)
Voluntary Voluntary
Mandatory
MDPWG WORK PROGRAMME
22
ACSDT CAPACITY
BUILDING
GHTF Recommendations
NOMENCLATURE for
medical devices
AMDD …..signed 2014
POST
MARKETING
ALERT SYSTEM..
To facilitate the integration of the medical devices sector through
elimination of technical barriers to trade in ASEAN
HARMONIZATION IN AMDD
Definition of medical device
Risk based classification
Standards -a similar level of quality assurance
(major features)
CSDT
EPSP
PMAS
Registration of product
Licencing of establishment
QMS ISO13485/ISO14971
23
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
24
INTRODUCTION TO ASEAN MEDICAL DEVICE DIRECTIVE
(AMDD)
MEDICAL DEVICES AUTHORITY, Ministry of Health Malaysia Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya,MALAYSIA
http://www.mdb.gov.my ● [email protected]
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
WHAT IS AMDD?
The AMDD is a legal and institutional framework for
the ASEAN Community to harmonise medical devices
regulation in the region. It is a common medical
device directive in ASEAN among Member States
(MS)
A key objective of the AMDD is to ensure only safe,
effective and quality medical devices are placed in
the ASEAN region.
25
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
• The primary goal is to protect public health and safety
• The level of regulatory control should be proportional to the degree of risk
• Expedites timely availability and access to safe and beneficial medical
devices and to prevent unsafe and ineffective medical devices from
entering the market
• Elements of control from design, manufacture and placement in the
market shall be put in place to ensure continued safety and quality
• In-line with global harmonization effort to minimize regulatory barriers,
facilitate international trade, improve access to new technologies and to
reduce the cost of implementing regulation
AMDD Guiding Principles
AMDD STRUCTURE
27
National Laws of Member States for Medical
Device Control
Transpose AMDD into National Laws
ARTICLE1
ARTICLE2
ARTICLE3
ARTICLE5
ARTICLE4
ANNEX1 ANNEX2 ANNEX3 ANNEX4 ANNEX5 ANNEX6 ANNEX7 ANNEX8
ARTICLE6
ARTICLE7
ARTICLE8
ARTICLE9
ARTICLE10
ARTICLE11
ARTICLE12
ARTICLE13
ARTICLE14-24
AMDD
ARTICLE
PROVISION
ARTICLE1 GENERAL PROVISION
ARTICLE 2 DEFINITION AND SCOPE
ARTICLE 3 ESSENTIAL PRINCIPLES OF SAFETY AND
PERFORMANCE OF MEDICAL DEVICE
ARTICLE 4 CLASSIFICATION OF MEDICAL DEVICES
ARTICLE 5 CONFORMITY ASSESSMENT OF MEDICAL DEVICE
ARTICLE 6 REGISTRATION AND PLACEMENT ON THE MARKET
ARTICLE 7 LICENSING OF PERSON RESPONSIBLE FOR PLACING
MEDICAL DEVICES ON THE MARKETS OF MEMBER
STATES
ARTICLE 8 TECHNICAL DOCUMENTS FOR MEDICAL DEVICES
ARTICLE 9 REFERENCE TO TECHNICAL STANDARDS
ARTICLE 10 LABELLING
ARTICLE 11 MEDICAL DEVICES CLAIMS
ARTICLE 12 POST-MARKETING ALERT SYSTEM
ARTICLE 13 CLINICAL INVESTIGATION 28
AMDD
ARTICLES
AMDD PROVISION
ARTICLE 14 INSTITUTIONAL ARRANGMENTS
ARTICLE 15 SAFEGUARD CLAUSES
ARTICLE 16 CONFIDENTIALITY
ARTICLE 17 SPECIAL CASES
ARTICLE 18 IMPLEMENTATION
ARTICLE 19 REVISIONS, MODIFICATIONS AND
AMENDMENTS
ARTICLE 20 DISPUTE SETTLEMENT
ARTICLE 21 RESERVATIONS
ARTICLE 22 ENTRY INTO FORCE
ARTICLE 23 ANNEXES
ARTICLE 24 DEPOSITARY
AMDD ANNEXES
29
ANNEX CONTENTS
ANNEX1 ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL
DEVICES
ANNEX 2 Risk Classification Rules for Medical Devices other than IVD Medical
Devices
ANNEX 3 Risk Classification Rules for IVD Medical Devices
ANNEX 4 ASEAN Common Submission Dossier Template
ANNEX 5 Post Marketing Alert System (PMAS) Requirements
ANNEX 6 Components Elements of a Product Owner’s or Physical Manufacturer’s
Declaration of Conformity (DOC)
ANNEX 7 Labelling Requirements
ANNEX 8 Clinical Investigation
AMDD
30
ARTICLE PROVISION CONTENTS
ARTICLE1 GENERAL PROVISION
Only medical devices which conform to the provisions
of this ASEAN Agreement on Medical Device Directive
and its Annexes may be placed on the markets of
that Member State
Medical device shall be registered with the
Regulatory Authority of that Member State.
The person responsible for placing the medical
device in that Member State or the authorised
representative shall be licensed.
ARTICLE 2 DEFINITION AND SCOPE “authorised representative” means any person in
a Member State who, explicitly designated by the
product owner, acts and may be addressed by
authorities and bodies in a Member State instead
of the product owner with regard to the latter’s
obligations under this Agreement, and relevant
laws and regulations of the Member State.
“authorised distributor”, in relation to the placing
on the market of a medical device, means any
person who has been authorised by the product
owner or authorised representative to distribute
the medical device in that Member State.
“manufacture”, in relation to a medical device,
means to make, fabricate, produce or process the
medical device and includes:
any process carried out in the course of so
making, fabricating, producing or processing the
medical device; and/or the packaging and
labelling of the medical device before it is
supplied.
31
ARTICLE PROVISION CONTENTS
ARTICLE 3 ESSENTIAL PRINCIPLES OF
SAFETY AND PERFORMANCE
OF MEDICAL DEVICE
Medical devices shall meet the essential
principles set out in Annex 1
ANNEX 1: ESSENTIAL PRINCIPLES OF SAFETY AND
PERFORMANCE OF MEDICAL DEVICES
ARTICLE 4 CLASSIFICATION OF
MEDICAL DEVICES
Medical devices shall be classified into the
following four classes, in accordance with risk
classification rules set out in Annex 2 (Risk
Classification Rules for Medical Devices other
than IVD Devices) and Annex 3 (Risk Classification
Rules for IVD Devices):
Class Risk Level
A Low risk
B Low-moderate risk
C Moderate-high risk
D High risk
ANNEX 2 ;RISK CLASSIFICATION RULES
FORMEDICAL DEVICES OTHER THAN IVD MEDICAL
DEVICES
ANNEX 3; 3RISK CLASSIFICATION RULES FOR IVD
MEDICAL DEVICES
32
ARTICLE PROVISION CONTENTS
ARTICLE 5 CONFORMITY ASSESSMENT OF
MEDICAL DEVICE
Assessed by the Regulatory Authority of that Member
State, or any appointed bodies recognised by that
Member State, for conformity and compliance unless
the medical device has been exempted
ARTICLE 6 REGISTRATION AND
PLACEMENT ON THE MARKET
A medical device which has been assessed by the
Regulatory Authority of that Member State or any
appointed bodies recognised by that Member State to
be in conformity and in compliance with the
requirements laid down in this Agreement may be
placed on the market of that Member State.
A medical device to be placed on the market of a
Member State shall be registered with the Regulatory
Authority of that Member State. The Regulatory Authority
of the Member State may exempt certain medical
devices from the requirement for registration where
appropriate.
33
ARTICLE PROVISION CONTENTS
ARTICLE 7 LICENSING OF PERSON
RESPONSIBLE FOR PLACING
MEDICAL DEVICES ON THE
MARKETS OF MEMBER STATES
Each Member State shall require a person who is
responsible for placing medical devices on the market to
be licensed by the Regulatory Authority of that Member
State before the medical devices are placed on the
market of that Member State.
ARTICLE 8 TECHNICAL DOCUMENTS FOR
MEDICAL DEVICES
ANNEX 4 ASEAN COMMON SUBMISSION DOSSIER
TEMPLATE
ANNEX5;POST MARKETING ALERT SYSTEM (PMAS)
REQUIREMENTS
ANNEX 6:COMPONENTS ELEMENTS OF A PRODUCT
OWNER’S OR PHYSICAL MANUFACTURER’S
DECLARATION OF CONFORMITY (DOC)
ARTICLE 9 REFERENCE TO TECHNICAL
STANDARDS
Technical standards recognised by the AMDC or other
technical standards accepted by the Regulatory
Authority of a Member State
34
ARTICLE PROVISION ANNEX
ARTICLE 10 LABELLING ANNEX 7: LABELLING REQUIREMENTS
ARTICLE 11 MEDICAL DEVICES CLAIMS Claimed benefits of a medical device shall be justified by
substantial evidence in accordance with the
requirements as set out in Annex 1
ANNEX 1: ESSENTIAL PRINCIPLES OF SAFETY AND
PERFORMANCE OF MEDICAL
ARTICLE 12 POST-MARKETING ALERT
SYSTEM
Each Member State shall require
• keep all relevant records
• inform the Regulatory Authority, any adverse
• inform the Regulatory Authority, to perform
FSCA.
AMDD STRUCTURE
35
ARTICLE PROVISION ANNEX
ARTICLE 13 CLINICAL
INVESTIGATION
Member States shall put in place an appropriate system for the
conduct of clinical investigation of medical devices.
The product owner, or his authorised representative, or the sponsor of
the clinical investigation in a Member State, register with the
Regulatory Authority of that Member State in which the investigations
are to be conducted.
Where a clinical investigation is refused or halted , inform all Member
States and the AMDC.
Where a Member State has called for a significant modification or
temporary interruption of a clinical investigation, that Member State
may inform all Member States and the AMDC concerned about its
actions and the grounds for the actions taken.
Notify of the end of the clinical investigation
In the case of early termination of the clinical investigation on safety
grounds, this notification may be communicated to the Regulatory
Authority of all Member States where the clinical investigation is
carried out.
ANNEX 8:CLINICAL INVESTIGATION
AMDD CONT…
36
AMDD
ARTICLES
AMDD PROVISION ANNEX
ARTICLE 14 INSTITUTIONAL ARRANGMENTS (1) The AMDC shall be established with the
overall responsibility of coordinating,
reviewing and monitoring the
implementation of this Agreement and shall
comprise representatives from the
Regulatory Authority of each Member State.
(2) The AMDC may establish an ASEAN Medical
Device Technical Committee (AMDTC) to
assist the AMDC in reviewing the technical
and safety issues.
37
AMDD
ARTICLES
AMDD PROVISION ANNEX
ARTICLE 15 SAFEGUARD CLAUSES Acknowledgment by each Member State
that a medical device placed on its
market shall not compromise health or
safety of patients
Member State shall immediately inform
other Member State of measures taken, it
shall take all appropriate interim
measures to withdraw such medical
device from the market or prohibit or
restrict their being placed on the market
or put into service
- Failure to conform to EPSP
- Incorrect application of Technical
Standards
- Shortcomings in the Technical
Standards
38
AMDD
ARTICLES
AMDD PROVISION ANNEX
ARTICLE 16 CONFIDENTIALITY Without prejudice to the existing national laws
and regulations, Member States shall require
that all the parties involved in the application
of this Agreement are bound to observe
confidentiality with regard to all confidential
information obtained in carrying out their tasks
ARTICLE 17 SPECIAL CASES Flexibility given to Member States for reason of
religious and cultural difference
Acknowledged by ASEAN to strictly observe the
provisions
39
AMDD
ARTICLES
AMDD PROVISION ANNEX
ARTICLE 18 IMPLEMENTATION Member States shall undertake appropriate
measures to implement this Agreement
ARTICLE 19 REVISIONS, MODIFICATIONS
AND AMENDMENTS
(1) The provisions of all or any part of this
Agreement may be revised, modified or
amended, by written agreement of all Member
States.
ARTICLE 20 DISPUTE SETTLEMENT The ASEAN Protocol on Enhanced Dispute
Settlement Mechanism signed on 29 November
2004 in Vientiane, Lao PDR and amendments
thereto, shall apply to the settlement of disputes
concerning the interpretation or implementation
of this Agreement
ARTICLE 21 RESERVATIONS Member States shall make no reservation with
respect to any of the provisions of this
Agreement.
40
AMDD
ARTICLES
AMDD PROVISION ANNEX
ARTICLE 22 ENTRY INTO FORCE This Agreement shall be subject to
ratification and/or acceptance by
Member States in accordance with their
internal domestic requirements.
This Agreement shall enter into force on 1
January 2015 and shall be in force only
among the Member States that have
ratified and/or accepted it.
ARTICLE 23 ANNEXES The Annexes to this Agreement constitute an
integral part of this Agreement.
ARTICLE 24 DEPOSITARY This Agreement shall be deposited with the
Secretary- General of ASEAN, who shall
promptly furnish each Member State a
certified copy thereof.
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
41
UPDATES ON
AMDD CURRENT TRANSPOSITION STATUS
IN MEMBER COUNTRIES
MEDICAL DEVICES AUTHORITY, Ministry of Health Malaysia Level 5, Boulevard Plot 3C4, No 26, Persiaran Perdana, Precinct 3, 62675 Putrajaya,MALAYSIA
http://www.mdb.gov.my ● [email protected]
Member States
Status
Brunei Darussalam
Ratification process expected to be completed by 2017
Cambodia Still in the process of ratification, expected to be ready by 2017.
Indonesia Still in the domestic process for ratification; The ratification of AMDD is targeted by 1st quarter of 2017;
Lao PDR AMDD has been ratified on 25 May 2015;
Malaysia Ratification of AMDD is expected by mid-2017.
Philippines
Ratification of AMDD is expected to be submitted by 2016.
Singapore
Instrument of ratification has been submitted to the ASEAN Secretariat on 10 November 2015;Ready to fully implement AMDD.
Thailand
Ratification of AMDD is expected to be submitted 2017.
Viet Nam
Viet Nam has submitted the Instrument of Acceptance of AMDD to the ASEAN Secretariat on 21 March 2016.
42
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
PROGRESS OF MDPWG TO AMDC
• Establishment of the ASEAN Medical Device Committee (AMDC)
• To coordinate,review and monitor the implementation of AMDD
• Comprise of representatives from Regulatory Authority of each Member
State
• The ACCSQ and ASEAN Secretariat shall support in coordinating and
monitoring the implementation of AMDD
• AMDC may establish ASEAN Medical Device Technical Committee (AMDTC)
to assist the AMDC in reviewing the technical safety and safety issues.
• Milestone for completion of transposition process and submission of
instrument of ratification by 2020. The milestone will include, among
others, the following items
(i) Development of Guidelines for implementation of AMDD,
(ii) Implementation of AMDD in phases,
(iii) Monitoring of the implementation of AMDD
(iv) Development of a matrix on common interpretation of AMDD
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
AMDC
GOAL 1
Harmonization of
Medical Device
Regulations in
ASEAN
GOAL 2 :
Implementation of
Program to improve
technical
infrastructure and
capacity building
GOAL 3 :
Co-operation/
collaboration with
international/
regional organization
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
General Principles
Medical device should be designed & manufactured in such a way that:
1. no compromise to clinical condition or safety of patients, or safety and health of users or other persons
2. control the risk so that residual risk is brought down to an acceptable level
3. Shall achieve the performance intended and designed , manufactured and packaged in such a way that they are suitable for one or more of the functions within the scope of the definition of a medical device
4. characteristics and performances in clause1,2 and 3 shall not be adversely affected to such a degree that they compromise the health or safety of patient or user and other persons during the lifetime of the device
5. characteristics and performances during their intended use will not be adversely affected under transport and storage conditions
6. benefits must be determined to outweigh any undesirable side effects
7. shall require clinical evidence, demonstrate it complies with epsp
Design and Manufacturing Principles
1. Chemical, physical and biological properties of the material used to minimise risk
2. Infection and microbial contamination eliminate or reduce as far as reasonably practicable and appropriate the risk of infection to any person
3. Manufacturing and environmental properties to remove or reduce as far as reasonably practicable the risk
4. Devices with a diagnostic or measuring function sufficient accuracy , precision and stability
5. Protection against radiation , exposure reduced as far as reasonably practicable and appropriate compatible with the intended purpose
6. Requirements for medical devices connected to or equipped with an energy source, ensure repeatability . reliability and performance according to intended purpose
7. Protection against mechanical risks
8. Protection against the risks posed to the patient by supplied energy or substances
9. Active implantable medical devices shall incorporate identification code
10. Protection against the risks posed to the patient for devices for self-testing or self- administration
11. Information supplied by manufacturer; identify device, product owner, how to use device
12. Clinical investigation
Essential Principles of Safety & Performance of Medical Device