UPDATES ON THE ASEAN MEMBER STATES. Washington, September 2014

Transcription

1 UPDATES ON THE ASEAN MEMBER STATES Washington, September 2014

2 WHERE WILL BE THE ASEAN COMMUNITY MEDICAL DEVICE SECTOR BY 2020? HOW IS IT GOING TO GIVE A BUSINESS IMPACT IN THE MEDICAL DEVICE SECTOR?

3 Facts and Figures Indicators Unit p/ Total land area km2 4,435,617 4,435,617 Total population thousand 617, ,096 Gross domestic product at current prices US$ million 2,320,840 2,398,154 GDP growth percent International merchandise trade US$ million 2,476,427 2,510,127 Export US$ million 1,254,581 1,270,467 Import US$ million 1,221,847 1,239,660 Foreign direct investments inflow US$ million 114, ,756 Visitor arrivals thousand 89,225 - Sources ASEANstats, ASEAN Secretariat

4 Cross culture... Language: Tagalog, Bahasa Indonesia, Bahasa Malaysia, Thai, Vietnamese, Lao, Mynmar, Cambodia, English (commonly used language) Diverse culture; Timing: 2020 convergence of regulations Interests: Local, British, French, American, Dutch, Portugese Local Government

5 Principles of ASEAN ECONOMIC COMMUNITY

6 FIGURE 1: POTENTIAL IMPACT OF AEC MEASURES ON THE GDP OF ASEAN MEMBER COUNTRIES (Cumulative percentage increase over baseline in 2015) Notes: Brunei is proxied by Rest of South-East Asia in the simulation. There are no estimates for Myanmar because of serious data problems Source: Mid-Term Review of the Implementation of AEC Blueprint: Executive Summary, October 2012, Eria; Itakura (2012). According to the Economic Research Institute for Asean and East Asia (Eria) (2012) [3], the AEC, when it happens, can bring in substantial benefits to member countries. Some of the more substantial benefits will come from services trade liberations and improved trade facilitation, and not from the complete elimination of tariffs. As Figure 1 shows, a marked percentage jump in GDP growth has certainly occurred for Laos, Cambodia and Vietnam.

7 TABLE 1: AEC SCORECARD, (% OF TARGETS ACHIEVED) Source: AEC Scorecard, Asean Secretariat, 2012.

8 ACCSQ- MDPWG AGENDA H A R M O N I S E D P R E M A R K E T S U B M I S S I O N F O R M AT : A D O P T I O N O F T H E C O M M O N S U B M I S S I O N D O S S I E R T E M P L AT E HARMONISATION H A R M O N I S E D S E T O F V O L U N TA R Y S TA N D A R D S I N A S E A N : B A S E D O N I E C A N D I S O S TA N D A R D S S H A R I N G O F : P O S T M A R K E T S A F E T Y I N F O R M AT I O N A M O N G A S E A N M E M B E R S TAT E S

9 ASEAN Medical Device Directive Agreed measures: Definition of medical devices Essential principles of safety and performance Risk classification rules Post-market vigilance and surveillance

10 ACCSQ-MDPWG Our accomplishment i. Developing a common submission dossier template for product approval in ASEAN Completed ii. iii. iv. Exploring the feasibility of an abridged approval process for medical devices which regulators of benchmarked countries or recognized regulators have approved Exploring the feasibility of adopting a harmonized system of placement of medical devices into the ASEAN markets, based on a common product approval process i.e., AMDD Formalizing of a post-marketing alert system for defective or unsafe medical devices. Ongoing Ongoing Completed v. All ASEAN countries to consider joining the Asian Harmonization Working Party (AHWP) and work in parallel with the Global Harmonization Task Force (GHTF) on technical harmonization efforts Ongoing 10

11 What are requirements of AMDD? Definition Device Classification Conformity Assessment Product registration and placement in the market Licensing of persons responsible Technical Standards Post market Vigilance and surveillance Common Technical documents o CSDT o Post Market Requirements o Declaration of Conformity

12 Countries with Legal Framework Countries with Legal Framework With Legal Framework Without Legal Framework NA No of Countries 8 1 1

13 What are being controlled? Member States Premarket Control Post market Comments Establishment Product Brunei N N Voluntary Cambodia Y Y N Indonesia Y Y Y Laos Y N N Product Registration in Process Myanmar N Y Y Regulate high risk products Malaysia Y Y Y Philippines Y Y Y Mandatory Product Recall Reporting Thailand Y Y Y Singapore Y Y Y Vietnam NA NA NA

14 Are we ready? Transposition of AMDD No of MS which has started the process of transposition No of MS which will start after 1 st Jan 2015 Y N Comments country will carry out partial transposition

15 Expected date for Mandatory Enforcement of AMDD Expected date of mandatory implementation No of Member States Immediate 2 By Once the National Laws are rectified 6

16 Progress of AMDD NO. STEPS TOWARDS ENDORSEMENT AND FINALISATION OF AMDD 1. Public Consultation by ASEAN Member States ACTIONS TO BE TAKEN Member states to conduct Public Consultation October 2013 TIMEFRAME 2. Amendments to AMDD Version 14 to incorporate comments Special HOD Meeting in Singapore to finalise AMDD Version 14 November AMDD Version 15 to be endorsed by ACCSQ. ASEAN Secretariat to send AMDD Version 15 to ACCSQ. Endorsement through e- communication by 1st December AMDD Version 15 to be endorsed by SEOM. ASEAN Secretariat to send the AMDD Version 15 to SEOM. Endorsement at SEOM 1/45 Meeting in January 2014 in Myanmar 5. AMDD to be signed ASEAN Secretariat to facilitate the signing of the AMDD by the AEM AEM Meeting at 25 th ASEAN Summit in August 2014

17 Progress of AMDD NO. STEPS TOWARDS ENDORSEMENT AND FINALISATION OF AMDD 1. Transposition of AMDD to National Regulatory Framework by Member States ACTIONS TO BE TAKEN Member states to carry out rectification of current laws Jan 2015 TIMEFRAME 2. Formation of ASEAN Medical Device Committee (AMDC) to monitor and review progress of transposition 3. Full transposition of AMDD in all ASEAN Member States Member states to formalise the setting up of AMDC and subsequently MDPWG ceased to function Full implementation of AMDD by ASEAN Member States Jan 2015 Jan 2020

18 What about Malaysia?

19 Scope of Regulatory Framework 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, decommissioning

20 Overview of The AMDD Regulatory Process PRE-MARKET PLACEMENT ON-MARKET POST-MARKET PRE-MARKET REVIEW Manufacturers of medical devices shall - ensure their products conform to EPSP (Art. 3) ensure their products are manufactured in accordance with GMP collect evidence of conformity Authority / Notified Bodies verifies evidence of conformity MEDICAL DEVICES REGISTRATION & LICENSING Establishment apply for register medical devices (Art. 6) Establishment apply for establishment license (Art. 7) Authority allows - registered medical devices to be placed into the market licensed establishments to do their business MEDICAL DEVICES WILL BE MADE AVAILABLE ON THE MARKET SURVEILLANCE & VIGILANCE Establishments shall- monitor safety & performance of their products carry out post-market obligations, e.g user training, complaint handling, FSCA, recall Authority monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the law

21 CONFORMITY ASSESSMENT SYSTEM OF AMDD FOR PRODUCT REGISTRATION Elements of CA QMS (ISO or equivalent) Post-market surveillance system (GHTF recommendations) Summary technical documentation (ASEAN CSDT) Declaration of conformity (DoC) (GHTF recommendations) Quality Mgmt System (QMS) For manufacturer, ISO or equivalent Declaration of Conformity (DoC) (Annex 6) A DoC is a declaration made by the manufacturer of a device that the device is in conformity with the regulatory requirements DoC declares that the manufacturer guarantees that each piece of the device sold is in conformity with the regulatory requirements Summary Technical Documentation (Annex 4) format ASEAN CSDT Compliance to EPSP (GHTF recommendations - Essential Principles of Safety & Performance of Medical Devices) (Art. 3) Acceptable standards or equivalence will be widely used (Art. 9)(GHTF recommendations-role of Standards in the Assessment of Medical Devices) Authority / Notified Bodies determines the adequacy of the documented evidence to support attestation of conformity Post-Market Surveillance System (PMS) (Annex 5) Distribution records Complaint records Adverse incident reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices) FSCA reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Content of Field Safety Notices)

22 Challenges Language of AMDD How many Member States have implemented the AMDD? What if member states are not ready with rectification after 2015? Capacity Building PMS alert system

23 CAPACITY BUILDING of the AMDD Committed to implement AMDD - Ongoing activities to realize technical harmonization of MD regulations among ASEAN Member States i. Training workshops in AMS targeted to assist local industry, understanding basics of MD regulations ii. Regulator training capacity building for AMS in collaboration with USAID iii. Studying implementation details - ASEAN Single Window iv. Studying implementation details - Registration using CSDT 23

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

25 Future? A Common Submission Dossier format to be used Same Definition Common Classification rules Agreed Standards Acceptable Conformity Assessment Participation in post market vigilance and surveillance among member states

26 Thank You