Chief Executive Medical Device Authority

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

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.

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

Malaysia Exports of Medical Devices

Gloves
RM 9.4 Billion RM 2.3 Billion

Medical Devices (Excluding Gloves)

7% Others 5% Orthopedic implants 11% Electro mechanical MD 12% Contraceptives 12% Catheters, syringes, needles & sutures 2.3 13%
Opthalmic

12%
28%

Radiation devices

Reusable instruments

Total Exports in 2011: RM11.7 Billion

Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU

Medical Device Industry Ecosystem in Malaysia

Materials: Rubber, Plastics, Steel, Electronics, etc. Consumables
Technology
Products Latex Plastic Glove, Contraceptives, Catheters, woundcare, Orthalmology, IVD, SUD

Surgical Instruments, Implants & Clinical Devices

Metal Machining Electronics

Healthcare Equipment
Furniture

Pacemaker, Orthopedics, Surgical instrument

Radiation equipment, Life Science Instrument, Electrodes, Hospital beds

Companies

Supporting Infrastructure
Sterilization Packaging Certification Biocompatibility And Clinical Trial UKM, Industry Group Education Training UM, USM, UKM, UniMap, PSDC, Medsociate, Neville Clarke Regulatory Medical Device Act 2012

Info Kinetics

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

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

Countries that currently regulate, or are in the process of developing regulations for, medical devices
EU

Canada

United States Cuba

Slovenia Turkey Slovakia

Japan China Israel India Thailand Malaysia Indonesia South Korea Hong Kong Taiwan Philippines

Colombia Peru Chile Brazil Argentina Venezuela

Uruguay

South Africa

Australia New Zealand

*29 Members

GHTF Founding Member

Regulations in Other Countries - Laws &

authorities for medical devices
Laws/regulations New Zealand China Medicines Act 1981 Medicines (Database of Medical Devices) Regulations 2003 The Regulation on Supervision & Administration of Medical Devices Regulatory authority Medicines & Medical Devices Safety Authority State Drug Administration State Admin for Technical & Quality Supervision State Admin for Entry/Exit Inspection & Quaratine Medical Device Control Division, Thai FDA Bureau of Health Devices & Technology, Dept of Health Center for Medical Device Regulation, HSA Directorate of Medical Device Production & Distribution MoH

Thailand Philippines Singapore Indonesia

Medical Device Act 1988 Ministerial Regulations 1 7 Law governing medical devices is being drafted Health Products Act Medical Devices Regulations Health Law No 23 1992

Regulatory status in various countries

Regulations in Other Countries - Laws &

authorities for medical devices
US Laws/regulations Regulatory authority Safety Medical Devices Act Center for Devices & Radiological Health, FDA Medical Devices User Fee & Modernization Act Code of Federal Register Part 800 900 Medical Devices Regulation 2002 under Consumer Medicines & Healthcare Protection Act 1987 Products Regulatory Agency Therapeutic Goods Act 1989 Office of Devices, Blood & Tissue, TGA Therapeutic Goods (Med Devices) Regulations 2002 Food & Drug Act Medical Devices Bureau, Therapeutic Product Medical Devices Regulations (No 1101) Directorate Medical Devices Regulations (No 1162) Amendment Medical Devices Regulations (No 1293) Quality System Pharmaceutical Affair Law Ministry of Health, Labour & Welfare Pharmaceutical Control Law Cabinet Orders & Ministerial Ordinances General regulations, has not had in place documents Medical Devices & Radiation providing details for approvals specific to products Health Dept, Korean FDA Regulatory status in various countries

UK Australia Canada

Japan

Korea

CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS - TRENDS
Australia

Harmonization (GHTF / MDPWG)

EU, EFTA

Singapore
Canada

high

Arab Saudi Chinese Taipei

Thailand Malaysia Indonesia

New Zealand Pakistan India South Africa Bangladesh

Japan Korea USA

Philippines
Mexico Argentina Brazil China
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

Columbia

Brunei Laos Cambodia Myanmar

Vietnam

low

low

Comprehensiveness

high

Reference: M. Gropp; Institute of Medicine, Washington, D.C; 2-3 March 2011

Aims of the Regulatory Framework

Ensure public health and safety
Assurance for safety and performance Timely access for beneficial medical technologies Prevent dumping ground for unsafe and defective medical devices

Facilitate trade and industry

Conducive environment for medical devices manufacturing Facilitate trade and export Promote health tourism

Scope of regulation-WHO Model

PRE-MARKET PLACEMENT ON MARKET
Distribution Supply Advertising

POST-MARKET

Design & development Manufacture, import/ export Packaging, labeling, storage

Surveillance & vigilance Installation, T&C, maintenance, calibration, repairs Operation, usage Decontamination, decommission, disposal

Medical Device Lifecycle What are the Activities?

MEDICAL DEVICES LIFE CYCLE IN HEALTHCARE FACILITIES- ROLES

MDA Devices register Establishment License MDA Devices registry
Replacement Planning, User requirements

Hosp. ensure Devices are regtrd Est. licenced Procurement Device Assessment-HTA

Disposal

Compentency

Maintenance

Installation/Testing & Commissioning/Acceptance

Use

Hosp. ensure T&C done

Field Safety Corrective Actions Incident reporting

Training

Hosp. Devices register

Elements of Regulatory Program

DEVICE
Safety, quality and performance, ERSP

ACTIVITIES
Pre-market, placement on the market, post-market

USE
Usage, personnel, maintenance

AUTHORITY TO GOVERN THE ELEMENTS

Survey the usage and inventory Establish Policy Directions

Act Regulations

Input from all stakeholders

Guidance Notes/ Code of good practices

Standards Registration and Vigilance system

Resources Allocation

Implement control and enforcement Action Plan The Medical Device Regulatory Framework

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

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.myucture of Medical Device Regulatory System MEDICAL DEVICE REGULATORY SYSTEM
MEDICAL DEVICE AUTHORITY ACT 2012 (ACT 738)
.. gives powers to

MEDICAL DEVICE ACT 2012 (ACT 737)

.. gives powers to

MINISTER OF HEALTH

CABs Users
Establishments Manufacturers LARs Distributors Exporters

MEDICAL DEVICE AUTHORITY

Chief Executive, officers, servants

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

MEDICAL DEVICE AUTHORITY

http://www.mdb.gov.my

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 Committees appointed by MDA - to assist it in the performance of the functions of the Authority

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

MEDICAL DEVICE AUTHORITY

http://www.mdb.gov.my

The Authority challenges

Training for Regulators Awareness program for Consumer/End User/Manufacturer/ Trader/Distributor/ Policy Marker/researcher/ etc

Premarket Requirements Placement on Market Capacity Building ACT 737 Post Market Requirements

Medical Device Authority

Legal Support Act/Regulation/ Guidance Notes/QMS Enforcement

Medical Device Regulatory Control Program

Legal Framework

Act 738 Fees and Budgetary Human Resource Finance

Harmonisation MRA/Agreements International Forums National/International Affairs and Policy

Infrastructure

Computerization (ICT) Resource Centre

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)

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

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

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

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

CARTA ORGANISASI PIHAK BERKUASA PERANTI PERUBATAN KKM (DILULUSKAN DALAM MESYUARAT JAWATANKUASA KHAS BAGI MENGKAJI JAWATANJAWATAN TINGKATAN TERTINGGI BIL. 1/2012 PADA 16 APRIL 2012)
ANGGOTA PIHAK BERKUASA PERANTI PERUBATAN\
PEJABAT PENASIHAT UNDANG-UNDANG
L 41 SETIAUSAHA PEJABAT N 27/28/N32

KETUA EKSEKUTIF
Jusa Utama C

BAHAGIAN PENDAFTARAN, PERLESENAN

& PRA PASARAN C54
CAWANGAN PENILAIAN & PENDAFTARAN PRODUK UMUM C52

BAHAGIAN DASAR, KOD & STANDARD

J 54

BAHAGIAN PENILAIAN KLINIKAL

C 52

UNIT KHIDMAT PENGURUSAN

N41

CAWANGAN DASAR & HUBUNGAN ANTARABANGSA J52

CAWANGAN PENILAIAN KLINIKAL UD 41/44/48/52/54

SUMBER MANUSIA /LATIHAN N36

CAWANGAN PENILAIAN & PENDAFTARAN PRODUK IVD C48

CAWANGAN AUDIT PEMATUHAN C48

CAWANGAN PENYELIDIKAN UD 41/44/48/52/54

PENTADBIRAN N17/22

CAWANGAN KAWALAN ESTABLISMEN & BADAN PENILAIAN PEMATUHAN (CAB) C48

CAWANGAN BANTUAN INDUSTRI J44

CAWANGAN RUJUKAN SAINTIFIK KEWANGAN/HASIL C48 W36 CAWANGAN ICT & PENGURUSAN MAKLUMAT F44 PENGURUSAN ASET & PEROLEHAN N17/22

CAWANGAN SURVELAN & VIGILAN C48

CAWANGAN PERHUBUNGAN AWAM S44

CAWANGAN KAWALAN PENGGUNAAN J44

Petunjuk:Jawatan Diisi Jawatan Belum Diisi

CAWANGAN PENGUATKUASAAN J44

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)

Architecture of 1MiDAS & Development Phase

Lists of

Public

Lists of licensed establishment

registered Medical Devices

Medical Device Classification

Lists of registered CAB

Lists of Safety Notice, Alert

Lists of recall medical device

Lists of competent personnel

Lists of registered service

User/ Customer

1
Service Establishment License Application CAB Registration Application Medical Device Registration Application

1
Incident Reporting

provider

Authority web page

Provider Registration Application

Competency

Export Permit Application

Registration Application

Pre-market
Establishment Medical Devices Classification Conformity Medical Device Registration Assessment Body (CAB) Registration

On-market
Advertisement Watch

Industrial Support
ISC R/ Standards development Export Permit Bilateral/ International Forum Multilateral Agreement

Post-market
Surveillance and vigilance Service Provider Registration

Management System
Knowledge Centre File & Talent Management

Intranet

Licensing

Auditing

Inspectorate

Complaint

1
Competency Registration Incident Reporting

Designated Device Premit

Document Management Quality Management System

Policy and Authority secretariet

Enforcement

Stakeholders enggagement, consultation and training

Trending

Finance

Secure link

Custom electronic banking Code

Standards Malaysia

CMIS

Bahagian Amalan Perubatan (Private Healthcare Facilities Act) - Licensed premis

RADIA, radiation equipment (Act 304)

Current Government ICT Initiative THIS, HIS, PHIS, Aset management, emesyaurat

MITI, MIDA, SEMITEC, Biotech Corp

EPF, Sosco, Income tax

SSA, Local Authority

MaHTAS Mohd Amin 2011

Medical Device: Implementation of the Act 737

Licensing of Establishments Phase 3: Imposition of other obligations

Phase 2: Imposition of GDP for other establishments

Phase 1: Imposition of ISO13485 for manufacturers

Registration of Products and CABs IVD

Phase 2: Registration of all Classes and IVD Phase 1: Registration of CAB

Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

Q1

2013

2014

2015

Voluntary

Transition

Mandatory

Thank You