TAIPEI, Taiwan, Nov. 5, 2012 /PRNewswire/ -- Taiwan Food and Drug Administration, Department of Health, Executive Yuan is hosting a series of international events on medical devices from the 2nd of November to the 8th of November. Events include 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". Taiwan's medical device industry has been booming in recent years and the Executive Yuan has included medical devices as one of the key areas of development for the domestic biotechnology industry. The Executive Yuan seeks to enhance the global competitiveness of domestic manufacturers and help the domestic industry actively gain a foothold in the global market with its "Taiwan Biotech Take-off Diamond Action Plan" for the biotechnology industry. In response to the global harmonization of medical device regulation, Taiwan Food and Drug Administration (TFDA) has been building a regulatory environment for medical devices that is in line with international standards. It participates actively in the international harmonization organizations for medical device regulation and seeks to host large-scale international conferences to promote transnational integration of resources and the exchange of experiences. Up to now, there have been over 400 attendees coming from 27 countries. The series of events to be held will 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. This brings immense honor to the Division of Medical Devices and Cosmetics at the TFDA. The division is in charge of the administration of industry regulations on medical devices in Taiwan as well as organization of the events.
Key participants of the events include Mr. 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. Dr. San-Cheng Chang, 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 will also be gracing the events.
Industry representatives who will be attending the events 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.
In addition to discussions on the progress of work of AHWP's policy and technical committee, the events will also see invited representatives of health authorities from various countries, representatives of international medical device organizations and industry experts assuming the role of trainers/lecturers on industry regulations. They will discuss clinical assessment, quality management systems, regulatory control of listed companies, medical device software control and other topics. They will also conduct a workshop in conjunction with APEC on medical device combination products. Advanced courses will also be conducted on the standards for review operations. This series of event will be one of the most important international events on medical device regulations in Asia in 2012. By participating in the activities, industry participants from Taiwan can interact with representatives of regulatory authorities and medical device entrepreneurs from around the world and establish channels of communication with respect to industry regulations, as well as promote global R&D manufacturing and marketing cooperation.
AHWP, a voluntary nonprofit organization, comprises of representatives of regulatory authorities and industry experts from 23 member countries across Asia, Arab states of the Persian Gulf and South America. It seeks to study and put forward ways to harmonize laws and regulations on medical devices in Asia and work with international organizations such as the Global Harmonization Task Force (GHTF) and Asia-Pacific Economic Cooperation (APEC) to develop regulatory requirements, procedures and standards on medical devices, to promote harmonization of global laws and regulations on medical devices.
Established in 2002, the APEC Life Sciences Innovation Forum (LSIF) comprises of representatives of regulatory authorities and industry experts from 21 member countries in the Asia Pacific region. It seeks to bring together government and industry representatives and academia in member countries to jointly promote life sciences innovation so as to support human health in the Asia-Pacific region.
An organization under the APEC LSIF, the APEC Harmonization Center (AHC) mainly promotes the harmonization of pharmaceutical regulations and it has successfully conducted activities, discussions and training courses on 11 related laws and regulations for products.
While TFDA works closely with international organizations such as APEC and AHWP toward global harmonization of medical device regulation, it is also making consumer centered regulatory reforms, domestically, to better ensure medical device safety and efficacy. Since its establishment, 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.
The international conference and workshops will also promote the harmonization of their medical device management systems with the rest of the world and help participants of the biomedical industry gain an understanding of the laws, regulations and supervisory requirements of various countries, so that they are in a better position to overcome obstacles in other countries in terms of technical documents. They will help industry players in Taiwan explore the global market and market their brands throughout the world.
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|SOURCE Department of Health, Executive Yuan, Taiwan|
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