Taiwan Food and Drug Administration, Department of Health, Executive Yuan hosted a series of international events on medical devices from 2nd of November to the 8th of November including “The 17th Asian Harmonization Working Party Annual Conference”, “2012 APEC-AHC-AHWP Joint Workshop on Medical Device Combination Products” and “2012 APEC Advanced Workshop of Good Review Practice on Medical Products”. This series of conferences set three records in Taiwan’s medical device industry — the largest number of participating countries, the largest number of participating officers from regulatory authorities around the world and the largest number of registration from foreign attendees. These records brought immense honor to the Division of Medical Devices and Cosmetics of TFDA for organizing the events.
Over 400 attendees coming from 27 countries attended these conferences and workshops. Key participants of the events includedMr. Mike Ward, chairman of the APEC Regulatory Harmonization Steering Committee (RHSC) and Manager of International Programs Division at Health Canada, Dr. Saleh S. Al-Tayyar, chairman of the Asian Harmonization Working Party (AHWP), Mr. Jeffrey Gren, director of the Office of Health and Consumer Goods, International Trade Administration, U.S. Department of Commerce, Mr. Laurent Selles, head of the Cosmetics and Medical Devices Unit, Directorate-General Health and Consumers, European Commission, Mrs. Elizabeth Baker from Medicine and Healthcare Products Regulatory Agency, UK, Mr. Kentaro Azuma from Japan’s Ministry of Health, Labour and Welfare, Mrs. Joanna Koh from Health Sciences Authority, Singapore, Mr. Guobiao Gao from the State Food and Drug Administration (SFDA) of the People’s Republic of China and other representatives of regulatory authorities on medical devices from various countries and regions. Industry representatives include Dr. Brian Snyder and Dr. Kulwant Saini, vice presidents of Johnson & Johnson Asia Pacific, Mr. Michael Gropp and Dr. Geraldine Finn, vice presidents of Medtronic from the US, Mr. Arthur Brandwood, CEO of Brandwood Biomedical from Australia and Ms. Siriphan Emrungroj, senior consultant at Thai Medical Device Technology Industry Association. Besides, Dr. San-ChengChang, Minister without Portfolio from Taiwan’s Executive Yuan, Dr. Huihua Chiang, executive secretary of the Office of Science and Technology of Taiwan’s Executive Yuan and Wen-Ta Chiu, Minister of Department of Health also graced the events.
TFDA has been working closely with international organizations such as APEC and AHWP toward global harmonization of medical device regulation and also making consumer centered regulatory reforms, domestically, to better ensure medical device safety and efficacy. TFDA has always served as the “gate-keeper” for medical device users, emphasizing on premarket evaluation. However, TFDA is taking a new direction to speed up pre-market evaluation and accelerate product to market timeframe, while enhancing post-market regulations. The implementation of Summary Technical Documentation (STED) and Good Review Practice (GRP) will help shorten the time for pre-market review, while plans to construct Total Product Life Cycle (TPLC) of the medical devices, strengthen and enhance illegal medical device inspection and reinforce post-market surveillance. To further ensure medical device safety and efficacy, TFDA has adopted ISO 13485: 2003 and started to establish risk-based inspection system to determine the priority and frequency of the quality system inspection of manufacturers. Lastly, regulation on the distributor will also be implemented through the establishment of Good Distributor Practice (GDP) to ensure the consistency of medical device quality. These reforms will not only allow better regulatory efficiency, but most importantly, better protect the health of medical device users.