(02-05-2013)
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.
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