Medical Device Authority Malaysia 22th November 2013

Transcription

1 Medical Device Authority Malaysia 22th November 2013

2 Malaysian Market Malaysia currently imports around 95% of the medical device for its consumption especially on active devices The medical devices industry :- 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.

3 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 Dominated by MNCs and local latex glove manufacturers Source: AMMI

4 Malaysia Exports of Medical Devices 7% Others 5% Orthopedic implants 11% Electro mechanical MD Medical 12% Contraceptives RM RM Devices 12% sutures (Excluding 13% 2.3 Opthalmic Billion Billion Gloves) 12% Radiation devices Gloves Catheters, syringes, needles & 28% Reusable instruments Total Exports in 2011: RM11.7 Billion Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU

5 Medical Device Industry Ecosystem in Malaysia Materials: Rubber, Plastics, Steel, Electronics, etc. Consumables Surgical Instruments, Implants & Clinical Devices Healthcare Equipment Technology Latex Plastic Metal Machining Implants IVDs, others Products Glove, Contraceptives, Catheters, woundcare, Orthalmology, Pacemaker, Orthopedics, Surgical instrument Radiation equipment, IVDs, Life Science Instrument, Electrodes, Hospital beds Companies Supporting Infrastructure Sterilization Packaging Certification Biocompatibility And Clinical Trial Industry Group Education Training Regulatory UKM, Info Kinetics UM, USM, UKM, UniMap, PSDC, Medsociate, Neville Clarke Medical Device Act 2012

6 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: )

7 Harmonization (GHTF / MDPWG) high low CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS - TRENDS New Zealand Pakistan India South Africa Bangladesh Brunei Laos Cambodia Myanmar low Thailand Malaysia Philippines Argentina Vietnam Indonesia Mexico Comprehensiveness Reference: M. Gropp; Institute of Medicine, Washington, D.C; 2-3 March 2011 EU, EFTA Arab Saudi Chinese Taipei Columbia Brazil China Korea Australia Singapore Canada Japan USA 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 high

8 Background Policy direction: Cabinet decision 2005 Policy: Regulatory framework for the control of medical devices in Malaysia Based on & harmonized with global regulatory model Using the WHO model, in-line with WTO agreement Adoption of ASEAN AMDD and Adoption of major trading partners egusa, Japan, Canada, EU and Australia regulatory requirements

9 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 Third party service for maintenance Facilitate trade and industry Conducive environment for medical devices manufacturing Facilitate trade and export Promote health tourism

10 Harmonised Regulatory Framework Definition of Medical Device Classification of Medical Device Pre-Market Requirements such as Essential Principles of Safety and Performance (6 Principles and 11 Performance) Requirements for placement on market such as labelling& advertisement Post Market requirements such Vigilance and Surveillance

11 Medical Devices Active Others (Non-Active) Medical Device Diagnostic Therapeutic Implantable Medical Device Non-Invasive Invasive Class A Class B Class C Class D Engineering Services Division Ministry of Health

12 MEDICAL DEVICE AUTHORITY 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) MINISTER OF HEALTH MEDICAL DEVICE AUTHORITY Chief Executive, officers, servants.. gives powers to CABs Users Establishments Manufacturers LARs Distributors Exporters

13 Overview of The Regulatory System PRE-MARKET PLACEMENT ON-MARKET POST-MARKET PRE-MARKET REVIEW All Manufacturers of medical devices shall - ensure their products conform to EPSP ensure their products are manufactured in accordance with GMP collect evidence of conformity CAB verifies evidence of conformity MEDICAL DEVICES ARE REGISTERED All Manufacturers (or LARs) apply for register medical devices MANUFACTURERS AND DISTRIBUTORS APPLY FOR LICENCE ensure compliance to GDP & advertising requirements- Distributor apply for establishment license to distribute medical devices MDA will allow:- registered medical devices to be placed into the market licensed establishments to do their business ONLY THEN MEDICAL DEVICES WILL BE MADE AVAILABLE ON THE MARKET MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law SURVEILLANCE & VIGILANCE Establishments shall- monitor safety & performance of their products carry out post-market obligations, eg user training, complaint handling, FSCA, recall USAGE & MAINTENANCE Users shall use, maintain & dispose off medical devices appropriately Users shall apply for permit to use/operate designated medical devices

14 Device Establishment Manufacturer Definition Labelling Brief Info Instruction for Use Intended Use Indication Contra-Indication Establishment Details Regulation Info. Details Indigenous International 6 General Principles 11 Design and Manufacturing Standards Essential Principles 4 risk classes Risk Criteria Premarket Classification Conformity Assessment Regulator Declaration of Conformity QMS / GDPMD CSDT Technical Documentation Post market Surveillance Procedure Documentation Review Register Medical Device

15 Intended Use Indication Device Establishment Manufacturer Definition Labelling Brief Info Instruction for Use Contra-Indication Establishment Details Regulation Info Details Clinical Evidence Indigenous International Standards Premarket Conformity Assessment Declaration of Conformity QMS / GDPMD Systematic Review Compliance of Evidence Literature search Ethical Committee Clinical Investigation Clinical Experience Considering the need for a clinical investigation Clinical Investigation Design 6 General 11 Design and Manufacturing Essential Principles CSDT Technical Documentation Post market Surveillance Procedure Data/Result Clinical Safety of Medical Device Testimonial from users 4 risk classes Risk Criteria Classification Regulator Documentation review Register Medical Device Suitability Quality Records Contribution of Results to Safety Performance Criteria for Appraisal Evaluation: Data Appraisal Report Qualitative Data Quantitative Data Pivotal Data Risk Benefit

16 Device Manufacturer Definition Labelling Intended Use Instruction for Use Clinical Evidence Indigenous International 6 General 11 Design and Manufacturing 4 risk classes Risk Criteria Planning Selection of potential supplier Supplier Evaluation and Acceptance Finalization of controls and responsibilities Feedback Delivery, and Communication Measurement and Monitoring Standards Essential Principles Classification Documentation Approve Registration Supplier/ Product Controls Premarket Regulator Conformity Assessment Quality Management System (QMS) Processes that should be validated Auditing Declaration of Conformity QMS / GDPMD CSDT Technical Documentation Post market Surveillance Procedure Safety via QMS Auditing in SG4 Risk Management Systematic Review Compliance of Evidence Safety via clinical evidence Management Responsibilities Suitability Quality Records Contribution of Results to Safety Performance Criteria for Appraisal Documentation and Communication Outsourcing Planning Design and Development Traceability Literature search Ethical Committee Purchasing Controls and Acceptance Activities Clinical Investigation Data/Result Clinical Safety of Medical Device Evaluation: Data Appraisal Report Clinical Experience Considering the need for a clinical investigation Clinical Investigation Design Testimonial from users Qualitative Data Quantitative Data Pivotal Data Risk Benefit Installation Qualification (IQ) Operational Qualification (OQ) Statistical Method and Tools Conduct of a validation Process Validation Production and Process Controls Servicing Analysis of Data Performance Qualification (PQ) Use of Historical Data Maintaining a state of validation Corrective and Preventive Action (CAPA)

17 MEDICAL DEVICE REGULATION APPLICATION MANUFACTURER Product Lifecycle Start QMS and Risk Management are applicable throughout the complete product lifecycle Definitions The Essential Principles/Standards QMS Design Control/ Risk Analysis QMS Design Control/ Risk Assessment QMS GMP QMS Design Control/ Risk Assessment Process Validation Clinical Evidence QMS GMP Labelling/Advertisement Device Requirements/Intended Use Design Input/Specifications Design Design Verification Pilot Production Device Validation Manufacturing Placing On The Market Market Performance Obsolescence/disposal Product Lifecycle End Technical Information CSDT Device Classification Conformity Assessment Registration of Medical Device Approval Registration Post Market Surveillance and Vigilance Usage, Maintenance and Servicing Audits Internal and External Certification Coverage of the complete quality management system

18 Why thewho Model? PRE-MARKET Design & development Manufacture, import/ export Packaging, labeling, storage PLACEMENT ON MARKET Distribution Supply Advertising POST-MARKET Surveillance & vigilance Installation, T&C, maintenance, calibration, repairs Operation, usage Decontamination, decommission, disposal

19 Medical Device Lifecycle What are the Activities?

20 Elements of Regulatory Program DEVICE Safety, quality and Performance according to EPSP ACTIVITIES Pre-market, placement on the market, post-market USE Usage, personnel, maintenance AUTHORITY TO GOVERN THE ELEMENTS

21 MEDICAL DEVICES LIFE CYCLE IN HEALTHCARE FACILITIES. Implications and roles of regulation MDA Devices register Establishment License MDA Devices registry Disposal Replacement Planning, User requirements Procurement Hosp. ensure Devices are regtrd Est. licenced Device Assessment-HTA Compentency of Biomedical Engrs Maintenance Installation/Testing & Commissioning/Acceptance Usage Hosp. ensure T&C done Field Safety Corrective Actions Incident reporting Training Hosp. Devices register

22 Challenges to the Authority Enforcement Legal capability Customer s expectation Fast, quality,cost Technology pressure Fast changing (online) Harmonisation Standards/regulations Awareness Dialog, Campaign The Medical Device Authority Regulatory 70,000 device, impact Training and capacity building Competency, knowledge Standards Mandatory, voluntary, industry Inter Agency Cooperation MDPWG, AHWP GHTF Globalisation WTO, Bilateral

23 Training for Regulators Awareness program for Consumer/End User/Manufacturer/ Trader/Distributor/ Policy Marker/researcher/ etc Legal Support Act/Regulation/ Guidance Notes/QMS Enforcement Capacity Building Medical Device Regulatory Control Program Legal Framework ACT 737 Medical Device Authority Premarket Requirements Placement on Market Post Market Requirements Act 738 Fees and Budgetary Human Resource Finance Harmonisation MRA/Agreements International Forums National/International Affairs and Policy Infrastructure Computerization (ICT) Resource Centre

24 Thank You