introduction to medical device act 2012 (act 737) and medical device authority act 2012 (act 738)
DESCRIPTION
Introduction to Medical Device Act 2012 (Act 737) and Medical Device Authority Act 2012 (Act 738) by Medical Device Authority (MDA)TRANSCRIPT
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Chief Executive
Medical Device Authority
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Global trend in Medical Devices
Global trend demand for Medical Devices
Estimated to about USD 290 billion 2009
Estimated increase:- USD 300 billion -2011
Estimated 10% increase annually
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Malaysian Market
Malaysia currently imports around 95% of the medical device for its consumption
The medical devices industry in Malaysia is a highly diversified industry that produces a broad range of products and equipment ranging from medical gloves, implantable devices, orthopaedic devices and dialysers to diagnostic imaging equipment and minimal invasive surgical equipment and other devices which can be used for medical, surgical, dental, optical and general health purpose.
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The Industry in Malaysia
190 small to large players in the country
(manufacturing, distribution, sales )
Export revenues of RM 11.7 Billion in 2011
Export CAGR of 10 % per annum from 2000 2011
Dominated by MNCs and local latex glove manufacturers
Source: AMMI
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9.4 2.3 2.3
28%
12%
13%
12%
12%
11% 5% 7%
Reusable instruments
Radiation devices
Opthalmic
Catheters, syringes, needles & sutures
Contraceptives
Electro mechanical MD Orthopedic implants
Others
Malaysia Exports of Medical Devices
RM
Billion
RM
Billion
Gloves Medical Devices (Excluding Gloves)
Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU
Total Exports in 2011: RM11.7 Billion
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Consumables Surgical Instruments,
Implants & Clinical Devices Healthcare Equipment
Technology Latex
Plastic Metal Machining Electronics Furniture
Products
Companies
Supporting Infrastructure
Sterilization Certification Packaging Biocompatibility And Clinical Trial
Materials: Rubber, Plastics, Steel, Electronics, etc.
Industry Group
Education Training
Regulatory
Glove, Contraceptives,
Catheters, woundcare,
Orthalmology, IVD, SUD
Pacemaker, Orthopedics,
Surgical instrument
Radiation equipment,
Life Science Instrument,
Electrodes, Hospital beds
UKM, UM, USM, UKM,
UniMap, PSDC,
Medsociate,
Neville Clarke
Medical
Device
Act 2012
Medical Device Industry Ecosystem in Malaysia
Info
Kinetics
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World Health Organization guidance Governments need to put in place policies that will address all elements related to medical devices, ranging from access to high quality, affordable products, through to their safe and appropriate use and disposal.
Policies will be unsuccessful unless they are translated into national regulations that are enforced by legislation and correlating sanctions, and that form an integral part of the overall national health system. Source: Medical device regulations: Global overview and guiding principles; World Health Organization, Geneva; 2003
(At: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf )
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Background
Policy direction: Cabinet decision 2005
Policy: Regulatory framework for the control of medical devices in Malaysia Based on & harmonized with global regulatory model Endorsed by WHO, in-line with WTO agreement Adopted by ASEAN member countries and major trading
partners eg USA, Japan, Canada, EU and Australia
Objectives of regulatory framework: To ensure availability, accessibility, safety and
performance of medical devices for patient care and public health
To facilitate trade and reduce technical barrier to trade To encourage innovations for economic growth
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United States
Peru
Canada
Chile
Argentina Uruguay
Brazil
Colombia
Venezuela
South Africa
China
Thailand
Malaysia
Australia
New Zealand
Taiwan
South Korea
Japan
Israel
Slovenia
Slovakia
EU
*29 Members
Turkey
Hong Kong
Philippines
Indonesia
Countries that currently regulate, or are in the process of developing
regulations for, medical devices
Cuba
GHTF Founding Member
India
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Laws/regulations Regulatory authority
New Zealand
Medicines Act 1981
Medicines (Database of Medical Devices) Regulations 2003
Medicines & Medical Devices Safety Authority
China The Regulation on Supervision & Administration of Medical Devices
State Drug Administration
State Admin for Technical & Quality Supervision
State Admin for Entry/Exit Inspection & Quaratine
Thailand Medical Device Act 1988
Ministerial Regulations 1 7
Medical Device Control Division, Thai FDA
Philippines Law governing medical devices is being drafted Bureau of Health Devices & Technology, Dept of Health
Singapore Health Products Act
Medical Devices Regulations
Center for Medical Device Regulation, HSA
Indonesia Health Law No 23 1992 Directorate of Medical Device Production & Distribution MoH
Regulations in Other Countries - Laws & authorities for medical devices
Regulatory status in various countries
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Regulations in Other Countries - Laws & authorities for medical devices
Laws/regulations Regulatory authority
US Safety Medical Devices Act
Medical Devices User Fee & Modernization Act
Code of Federal Register Part 800 900
Center for Devices & Radiological Health, FDA
UK Medical Devices Regulation 2002 under Consumer Protection Act 1987
Medicines & Healthcare Products Regulatory Agency
Australia Therapeutic Goods Act 1989
Therapeutic Goods (Med Devices) Regulations 2002
Office of Devices, Blood & Tissue, TGA
Canada Food & Drug Act
Medical Devices Regulations (No 1101)
Medical Devices Regulations (No 1162) Amendment
Medical Devices Regulations (No 1293) Quality System
Medical Devices Bureau, Therapeutic Product Directorate
Japan Pharmaceutical Affair Law
Pharmaceutical Control Law
Cabinet Orders & Ministerial Ordinances
Ministry of Health, Labour & Welfare
Korea General regulations, has not had in place documents providing details for approvals specific to products
Medical Devices & Radiation Health Dept, Korean FDA
Regulatory status in various countries
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Philippines
Mexico
Australia
CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS - TRENDS lo
w
hig
h
high low
Har
mo
niz
atio
n (
GH
TF /
MD
PW
G)
Comprehensiveness
Singapore EU, EFTA
Canada Arab Saudi
Chinese Taipei
Japan
USA Korea
Thailand
China Brazil
Columbia Argentina
Pakistan
New Zealand
Bangladesh
India South Africa NOTES: Position in clusters not necessarily
significant Subjective assessment of many variables Variables not weighted Not all countries that regulate medical
devices shown Some countries moving faster than others
and with different paths
Brunei
Cambodia
Laos Vietnam
Indonesia
Myanmar
Malaysia
Reference: M. Gropp; Institute of Medicine, Washington, D.C; 2-3 March 2011
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Aims of the Regulatory Framework
Conducive environment for medical devices manufacturing
Facilitate trade and export
Promote health tourism
Ensure public health and safety Facilitate trade and
industry Assurance for safety and
performance
Timely access for beneficial medical technologies
Prevent dumping ground for unsafe and defective medical devices
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Design & development Manufacture, import/
export Packaging, labeling,
storage
POST-MARKET PRE-MARKET PLACEMENT ON MARKET
Distribution Supply Advertising
Surveillance & vigilance Installation, T&C,
maintenance, calibration, repairs
Operation, usage Decontamination,
decommission, disposal
Scope of regulation-WHO Model
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Medical Device Lifecycle What are the Activities?
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MEDICAL DEVICES LIFE CYCLE IN
HEALTHCARE FACILITIES- ROLES
Procurement
Use
Disposal
Hosp. Devices register
Incident reporting
Device Assessment-HTA
Training
Replacement Planning, User
requirements
Field Safety Corrective
Actions
Installation/Testing & Commissioning/Acceptance
MDA
Devices register Establishment
License
Maintenance
MDA Devices registry
Compentency
Hosp. ensure Devices are regtrd
Est. licenced
Hosp. ensure T&C done
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Elements of Regulatory Program
USE Usage, personnel,
maintenance
DEVICE Safety, quality and performance, ERSP
ACTIVITIES Pre-market, placement on the
market, post-market
AUTHORITY TO GOVERN THE ELEMENTS
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Standards
Guidance Notes/
Code of good practices
Regulations
Act
Survey the usage and inventory
Establish
Policy
Directions
Input from all
stakeholders
Registration and
Vigilance system
Resources
Allocation
Implement control and enforcement
Action Plan The Medical Device Regulatory Framework
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Current Status
Medical Device Act (Act 737) 2012 Appointed date for the Medical Device Act is 1st July 2013
Medical Device Regulations 2012 Appointed date for the Medical Device Regulations is 31st December
2012
Medical Device Authority Act (Act 738) 2012 Appointed date for the Medical Device Authority Act is 15 March 2012
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Chief Executive, officers, servants
MEDICAL DEVICE AUTHORITY
MINISTER OF HEALTH
Institutional st MEDICAL DEVICE AUTHORITY http://www.mdb.gov.myucture of Medical Device Regulatory System
MEDICAL DEVICE REGULATORY SYSTEM
MEDICAL DEVICE
AUTHORITY ACT 2012
(ACT 738)
MEDICAL DEVICE ACT
2012 (ACT 737)
CABs
Establishments
Manufacturers LARs Distributors Exporters
Users
.. gives p
ow
ers to
.. gives p
ow
ers to
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
Medical Device Authority (Act 738) 2012
To provide for the establishment of the Medical Device Authority with powers to control and regulate medical device, its industries and activities, and to enforce the medical device laws, and for related matters
The Act may be cited as the Medical Device Authority Act (Act 738) 2012
Come into operation on the appointed date by the Minister by notification in the Gazette on the 15th March 2012
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MEDICAL DEVICE
AUTHORITY (MDA)
A Statutory Body with the
following members - DG of Health as the Chairman
- Chief Executive
- a representative of Min of Health
- a representative of Min of
Finance
- not more than five persons
appointed by the Minister, who
have expertise and experience in
medical device matters
Functions of MDA
To implement, enforce, consider and recommend reform to the medical device laws
To perform the following :- - to regulate all matters
- to encourage & promote the development
- 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 such manner as the Authority may think expedient
To impose fees or charges for services rendered
Committees appointed by MDA
- to assist it in the performance of
the functions of the Authority
MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
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The Authority challenges
MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
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Medical Device
Regulatory Control
Program
Training for Regulators Premarket Requirements
Placement on Market
Post Market Requirements
Act 738
Fees and Budgetary Act/Regulation/
Guidance Notes/QMS
Harmonisation
National/International Affairs and Policy
Computerization (ICT)
Resource Centre
Capacity Building
ACT 737
Awareness program for
Consumer/End User/Manufacturer/ Trader/Distributor/
Policy
Marker/researcher/ etc
Infrastructure
Legal Framework
Medical Device
Authority
MRA/Agreements
Enforcement
International Forums
Human Resource
Finance
Legal Support
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
MISSION : To provide regulatory control of medical device industry in Malaysia through compliance of the act by ensuring safety and performance of medical device product to protect public
VISION : To become excellent medical device
regulatory authority recognised globally
CUSTOMER VALUE PROPOSITION: 1. Attributes -(Reliability, Consistent, Efficient), 2. Relationship -(Consultative, Customer-centric, Impartial), 3. Image -(Rule of Law-Ensure all documents process
efficiently and effectively compliance to regulatory)
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
STRATEGIC THEME
Excellence in delivery through; 1. Technologically driven 2. Customer / Stakeholder strategic alliance
STRATEGIC RESULTS 1. Facilitate, timely & accurate execution of approvals 2. A systematic, reliable and secured data management 3. Collaborative, consultative relationship that exceed
customer, employees & stakeholders expectation
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
Keys to success Initial budget obtained
Completed first phase of recruiting staff based on the approved list obtained when the BKPP cease to operate since 31 June 2012 for 60 staffs
Endorsement from MDA for the additional posts required for the full running of the MDA as approved by KKM
On going registration of products, licensing of establishment and registration of Conformity Assessment Bodies through MedCast IT based systems
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
START UP SUMMARY
On going efforts to fill up promotional posts Completed recruitment processes and setting up
various human resource committees MDA has finalised and endorsed additional manpower
requirements Established a financial system ( Salary, Procurement &
Accounts) including committees to exercise its commitments
Established infrastructure (IT & Others) requirements to enable online to fulfill the regulatory system
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
START UP SUMMARY
Established new Location and place of doing business
Established statutory identity and logo
Completed start up procurement of assets
On going Awareness program to industry, users and organisations
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CARTA ORGANISASI PIHAK BERKUASA PERANTI PERUBATAN KKM (DILULUSKAN DALAM MESYUARAT JAWATANKUASA KHAS BAGI MENGKAJI JAWATANJAWATAN TINGKATAN TERTINGGI
BIL. 1/2012 PADA 16 APRIL 2012)
BAHAGIAN
DASAR, KOD & STANDARD
J 54
Petunjuk:-
KETUA EKSEKUTIF
Jusa Utama C
Jawatan Diisi
Jawatan Belum Diisi
CAWANGAN
PENILAIAN & PENDAFTARAN
PRODUK IVD
C48
C48
CAWANGAN
KAWALAN ESTABLISMEN &
BADAN PENILAIAN PEMATUHAN
(CAB)
CAWANGAN
DASAR & HUBUNGAN
ANTARABANGSA
J52
C48
CAWANGAN
SURVELAN & VIGILAN
CAWANGAN
AUDIT PEMATUHAN
C48
PEJABAT
PENASIHAT UNDANG-UNDANG
L 41
BAHAGIAN
PENDAFTARAN, PERLESENAN & PRA PASARAN
C54
-
CAWANGAN
PENGUATKUASAAN
J44
N36
SUMBER MANUSIA
/LATIHAN
CAWANGAN
ICT &
PENGURUSAN MAKLUMAT
F44
SETIAUSAHA PEJABAT
N 27/28/N32
ANGGOTA PIHAK BERKUASA PERANTI PERUBATAN\
CAWANGAN
PENILAIAN & PENDAFTARAN
PRODUK UMUM
C52
BAHAGIAN
PENILAIAN KLINIKAL
C 52
CAWANGAN
BANTUAN INDUSTRI
J44
CAWANGAN
PERHUBUNGAN AWAM
S44
-
CAWANGAN
KAWALAN PENGGUNAAN
J44
N17/22
PENTADBIRAN
W36
KEWANGAN/HASIL
N17/22
PENGURUSAN ASET
& PEROLEHAN
UNIT
KHIDMAT PENGURUSAN
N41
CAWANGAN
PENILAIAN KLINIKAL
UD 41/44/48/52/54
CAWANGAN
RUJUKAN SAINTIFIK
C48
CAWANGAN
PENYELIDIKAN
UD 41/44/48/52/54
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MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my
Information Technology Systems
Medical Device Computerised Application System (MeDCASt) will developed to support the scope of regulatory control in terms of product registration
It will also provide the basis for :
Licencing of establisments (manufacturer, Local Authorised Representative and importer) to enable them to register medical device
Register Conformity Assessment Body (CAB)
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Pu
blic
U
ser/
Custo
me
r In
tra
ne
t S
ecure
lin
k
Authority web
page
Lists of licensed
establishment
Lists of
registered
Medical
Devices
Lists of
Safety Notice,
Alert
Lists of
recall medical
device
Pre-market
Medical
Device
Registration
Establishment
Licensing
Medical
Devices
Classification
Conformity
Assessment
Body (CAB)
Registration
On-market
Inspectorate
Advertisement
Watch Auditing
Complaint
Enforcement
Industrial Support
Bilateral/
Multilateral
Agreement
ISC R/
Standards
development
Export
Permit
International
Forum
Stakeholders enggagement,
consultation and training
Post-market
Incident
Reporting
Surveillance
and vigilance
Service
Provider
Registration
Designated
Device Premit
Competency
Registration
Management
System
Finance
Knowledge
Centre
Talent
Management
Policy and
Authority
secretariet
Quality
Management
System
electronic banking Custom
Code
RADIA, radiation
equipment (Act 304)
EPF, Sosco,
Income tax
MaHTAS
Establishment
License
Application
CAB
Registration
Application
Service
Provider
Registration
Application
Medical
Device
Classification
Competency
Registration
Application
Incident
Reporting
File &
Document
Management
Standards
Malaysia CMIS Bahagian Amalan
Perubatan (Private
Healthcare Facilities
Act) - Licensed premis
Current Government
ICT Initiative
THIS, HIS, PHIS, Aset
management, e-
mesyaurat
MITI, MIDA,
SEMITEC,
Biotech
Corp
Mohd Amin 2011
Lists of
registered
CAB
Export
Permit
Application
Trending
Lists of
competent
personnel
Lists of
registered
service
provider
SSA,
Local
Authority
Medical Device
Registration
Application
Architecture of 1MiDAS & Development Phase
2
3
4
5
6
1
1
1
1
1
-
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2013 2014 2015
Medical Device: Implementation of the Act 737
Re
gist
rati
on
of
Pro
du
cts
and
CA
Bs
IVD
Phase 1: Registration of CAB
Phase 2: Registration of all Classes and IVD
Lice
nsi
ng
of
Esta
blis
hm
en
ts
Phase 3: Imposition of other obligations
Phase 2: Imposition of GDP for other establishments
Phase 1: Imposition of ISO13485 for
manufacturers
Voluntary Transition Mandatory
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Thank You