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]
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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
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
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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
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Pihak Berkuasa Peranti Perubatan KEMENTERIAN KESIHATAN MALAYSIA
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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
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.
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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