Improving ASEAN Healthcare Through Medical Device Regulation Harmonization
As ASEAN moves towards the ASEAN Economic Community (AEC) in 2015, healthcare remains a high priority sector to be integrated across the region and vital to successful integration of the sector is the harmonization and efficiency of its regulations. To boost the capability of ASEAN medical device regulators and the medical device industry, over 40 ASEAN medical device regulators met in Malaysia last week at the Medical Devices Regulatory Harmonization Training Program.
The workshop is the first of a multi-year medical devices training program for ASEAN that will ensure ongoing improvement in the understanding and interpretation of the ASEAN Medical Device Directive (AMDD). The AMDD requires ASEAN countries to implement standardized medical device classification criteria and device placement systems, and to establish post-marketing surveillance alert systems. The Medical Device Product Working Group (MDPWG), which is one of 11 bodies of the ASEAN Consultative Committee for Standards and Quality (ACCSQ), developed the draft AMDD.
“The AMDD will help reduce red tape and boost the efficiency of trade in medical devices in the region,” said Matthew Hein of the US Department of Commerce. “It will clarify and delineate the many roles and responsibilities held by regulators in bringing and keeping medical devices in the marketplace and it will not only make the role of regulators more straightforward, it will bring the people of ASEAN improved access to medical technologies.”
Topics covered in the workshop included a big-picture overview, product life cycles, roles and responsibilities of regulatory authorities, the definition of a medical device, risk management, conformity assessment, listing and registration of devices, and post-market surveillance to provide regulators rapid identification of defective or unsafe devices.
“The training program is aimed at high-level ASEAN medical device regulators,” said Michael Flood, a former senior official in Australia’s Therapeutic Goods Administration with over 30 years of experience working with medical devices. Mr Flood, responsible in the development of the ASEAN medical device training curriculum, added that “we expect feedback from this meeting will help guide us in selecting areas of the syllabus to give greater focus to in future ASEAN-wide training programs.”
Following the implementation of the AMDD, uniform systems and regulations that come with the directive are expected to help improve patient safety standards across the region as well as providing a more straightforward path to market in the region for manufacturers of medical devices.
“Successful introduction and implementation of the AMDD will require regulatory agencies of each of the ASEAN Member States to have a thorough understanding of both the underlying philosophies of the Global Harmonization Task Force and the basic building blocks which, when integrated, provide a robust and adaptable framework aimed at ensuring citizens of each of the ASEAN Member States have timely access to safe and effective medical devices. This series of training will help ASEAN medical device regulators forge a common understanding and interpretation of the provisions of the AMDD,” said Mr. Zamane Abdul Rahman, Chairman of the MDPWG.
The U.S. Government-funded ASEAN-U.S. Technical Assistance and Training Facility in collaboration with the Ministry of Health of Malaysia and the ASEAN Secretariat organised the Medical Devices Regulatory Harmonization Training Program on 22-23 April 2013 in Petaling Jaya, Selangor, Malaysia.