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Led by TFDA, medical devices and cosmetic products soar to perfection, taking public life and health under their wings

  • Data Source:Ministry of Health and Welfare
  • Created:2013-08-09
  • Last Updated:2017-02-03

Food and Drug Administration, Department of Health has been reorganized as “Food and Drug Administration, Ministry of Health and Welfare” (TFDA) in coordination with the establishment of Ministry of Health and Welfare on July 23, 2013. To keep up with the prosperous development of domestic medical device and cosmetic product industries, the ministry will not only stick to the all-dimensional systematic management approach, but also introduce a new policy direction and the focus of business execution, protecting public health without hindering the development of the industries. The ministry has launched such policies as “Unique Device Identification (UDI) for high-risk medical devices”, “Good Distribution Practice (GDP)” and “enhancing consumer education and promotion in hygiene” so as to nip illegal medical devices in the bud before they find their ways to the market. These policies also set up a care network for medical device safety. 
The ministry also implemented the following strategies: introducing risk management models to medical device and cosmetic product factory management systems, carrying out a prospective “Guideline of Good Review Practice (GrevP) & Good Submission Practice (GSP)”; creating a perfect, high-quality environment for clinical trials of medical devices and human subject research of cosmetic products; building up a “seamless bridging counseling network within the industries”, a “goal-oriented bilateral and multilateral cooperation and exchange between international organizations” and a “regulatory system of modernized medical devices and cosmetic products” , which all aim at raising product safety, effectiveness and quality as well as boosting the development of the industries. 
Since the establishment of Food and Drug Administration on January 1, 2010, the management and development of domestic medical devices and cosmetic products have been planned and implemented as an ad hoc task. Over the past three and a half years, the TFDA has been promoting numerous management and reform measures targeting medical devices and cosmetic products which include building up a rationalized and transparent regulation review and management system and improving the review time limit year by year until it reaches the international standard. In order to achieve the goal “Provide all necessary documents and a license can be issued right away”, applications for changing and extending cosmetic product licenses and advertisements can be completed at the TFDAs front desk. The TFDA also set up a counseling mechanism for the industries, with the aim to achieve three “firsts”- approving the first clinical trial of advanced cartilage defect treatment in the world, generating a clinical trial of the most innovative negative pressure medical device for sleep apnea and launching the first one-piece artificial tooth root made in Taiwan. 
The TFDA tactically eliminated barriers to international cooperation by becoming the 28th member of the global NCAR in 2010. Thus, it is able to guarantee consumer safety in every aspect. Taiwans representative was elected as the vice-president of Asian Harmonization Working Party (AHWP) in 2011 and successfully held the 17th AHWP Annual Conference, signing memorandums of understanding for cooperation and technical cooperation projects with multiple nations. Taiwan also attended this years (2013) IMDRF(International Medical Device Regulators Forum) Management Committee Conference as the representative of AHWP and fully demonstrated our countrys regulations of medical devices and sophisticated technology which paved the way for the industries to the international market. 
Medical devices are the pillar of public health while cosmetic products serve as a good helper for the modern people. Bearing the responsibility as a gatekeeper of the quality of medical devices and cosmetic products, the TFDA will unceasingly work hard on improving all kinds of measures to provide our citizens with a better quality of life.