title: A study of medical device regulation management model in Asia.
abstract: BACKGROUND
  With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes.
  
  
  METHODS
  The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.
authors.affiliation: a Center for Measurement Standards , Industrial Technology Research Institute , Hsinchu , Taiwan.
authors.forename: Yi-Hui
authors.initials: YH
authors.lastname: Wu
authors.affiliation: a Center for Measurement Standards , Industrial Technology Research Institute , Hsinchu , Taiwan.
authors.forename: Fong-An
authors.initials: FA
authors.lastname: Li
authors.affiliation: a Center for Measurement Standards , Industrial Technology Research Institute , Hsinchu , Taiwan.
authors.forename: Yin-Ting
authors.initials: YT
authors.lastname: Fan
authors.affiliation: b Division of Medical Devices and Cosmetics , Ministry of Health and Welfare , Taipei , Taiwan.
authors.forename: Pei-Weng
authors.initials: PW
authors.lastname: Tu
mesh_terms: D001208:Asia; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D062307:Medical Device Legislation / Q000458:organization & administration* / Q000592:standards* / Q000639:trends*
keywords: Asia; Good Manufacturing Practice (GMP); Medical device; regulation; third-party review