Third WHO Global Forum on Medical Devices. South East Asia Regional Perspective

Transcription

1 Third WHO Global Forum on Medical Devices South East Asia Regional Perspective

2 Medical device regulatory systems in SEAR National medicines policies exists in most countries and some of these also cover other health technologies like medical devices Most countries have well established regulatory framework for medicines/vaccines regulation BUT Only India, Indonesia and Thailand has well developed regulations and regulatory system in place for medical devices Other countries either have no regulations or in the process of developing national regulatory system for medical devices

3 Regulatory system challenges in SEAR countries need for systemic reforms and capacity development Often large number of products on sale in the market difficult to monitor quality and safety Inadequate technical capacity to evaluate dossiers for marketing authorization Limited capacity to for GRX inspections of licensed manufacturers, distributors and retailers Limited capacity to for post marketing monitoring and materiovigilance Little collaboration Insufficient infrastructure HR, Limited organizational capacity: leadership capacity Lack of sustainable financing for operational budget Legislative framework with gaps or outdated standards lack of effective regulatory policies and tools Insufficient political will to support to NRA, political interference, poor governance, regulatory capture

4 Regional Regulatory Initiatives on medical devices ASEAN Medical Device Directive AMDD 2014 Applicable to: Indonesia, Myanmar and Thailand within SEAR + other 7 members states of ASEAN AMDD created uniform requirements for device registration, quality system compliance and related issues Ratification of AMDD is on progress in Indonesia and Thailand, with target in 2017

5 INDIA Make in India campaign: launched with focus on 25 sectors including medical devices 100 per cent FDI allowed: The medical device sector was carved out from the pharmaceutical sector thereby allowing 100 per cent FDI under the automatic route, for brownfield as well as greenfield set-ups. Draft National Medical Device Policy, 2015 released: The Ministry The of DoP Health and Family recently Welfare issued the has draft notified Medical National Medical Devices Device Rules, 2017 on Policy, , which The sets new Rules have out been the framed regulatory in conformity with structure Global for Harmonisation medical Task Force devices. (GHTF) framework and WHO Guidelines to comply with best international practices Sept 2014 Oct 2014 Dec 2014 Jan 2015 Apr 2015 Jun 2016 Jan 2017 Formation of Task Force: The DoP constituted a task force to identify issues relating to the promotion of domestic production of high end medical devices. Draft Drugs & Cosmetics (Amendment) Bill, 2015 released: The bill proposes to expand the scope of the Act to cover new areas and will regulate the import, manufacture, distribution and sale of drugs, cosmetics, medical devices. The amendment is likely to be approved soon. Funding approval to AMTZ: AMTZ receives approval for funding by the state cabinet on 1st June, 2016 for setting up Asia s first dedicated medical device park at Visakhapatnam.

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7 Regulatory Landscape: Government Support & Initiatives for Medical Devices Sector

8 Medical Device Clusters in India

9 Indonesian Medical Devices Regulation Indonesia has been regulating Medical Device since Medical Device is regulated by the Ministry of Health (MOH) in Indonesia whose objective is to increase the availability, distribution, and affordability of medical devices as well as to ensure its safety, efficacy, benefits, and quality. The primary government agency in charge of regulations for medical devices and pharmaceuticals is the National Agency of Drug and Food Control (NA-DFC). While Indonesia has no overarching medical device regulation, it has implemented global quality norms such as ISO in an attempt to harmonize its regulations with existing international law. Medical device is regulated under INDONESIA MOH Decree 1190/2010. In August 2014, the Association of Southeast Asian Nations (ASEAN) signed a formal agreement that harmonized medical device regulations. This agreement, formally called the ASEAN Medical Device Directive (AMDD), provides a more straightforward path to the market for medical device manufacturers across 10 ASEAN countries.

10 Thailand: AMDD: ASEAN Agreement on Medical Device Directive Signed on 21 November 2014 (10 ASEAN Countries) Approved by the Thai National Legislative Assembly on 13 May 2016 Plan to make ratification to the Secretary-General of ASEAN by the end of the year 2017

11 Thai FDA Notification on 1 April 2015: Classification of Medical Devices ( conforming to AMDD: ASEAN Agreement on Medical Device Directive) Non IVD medical devices IVD medical devices (16 Rules) Class 1 Low risk Class 2 Low-moderate risk Class 3 Moderate-high risk Class 4 High risk (7 Rules) Class 1 Low Individual Risk and Low Public Health Risk Class 2 Moderate Individual Risk and/or Low Public Health Risk Class 3 High Individual Risk and/or Moderate Public Health Risk Class 4 High Individual Risk and High Public Health Risk

12 Thank you! Good Health Adds Life to Years Disclosure- No Conflict of Interest