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A comparison study of Taiwan regulation and GHTF regulatory model on in vitro diagnostic medical devices.
Tsai, Wen-Wei; Tu, Pei-Weng; Lin, Hsin-Hui; Wang, Yin-Hsuan; Wu, Shiow-Ing; Fan, Yin-Ting.
Affiliation
  • Tsai WW; a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
  • Tu PW; a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
  • Lin HH; a Division of Medical Devices and Cosmetics , Food and Drug Administration, Ministry of Health and Welfare , Taipei , Taiwan.
  • Wang YH; b Office of Medical Device Evaluation , Center for Measurement Standards, Industrial Technology Research Institute , Hsinchu , Taiwan.
  • Wu SI; c Food and Drug Administration , Ministry of Health and Welfare , Taipei , Taiwan.
  • Fan YT; b Office of Medical Device Evaluation , Center for Measurement Standards, Industrial Technology Research Institute , Hsinchu , Taiwan.
Expert Rev Med Devices ; 14(4): 285-296, 2017 Apr.
Article in En | MEDLINE | ID: mdl-28298137
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Full text: 1 Database: MEDLINE Main subject: Reagent Kits, Diagnostic / Device Approval Type of study: Diagnostic_studies / Guideline Limits: Humans Country/Region as subject: Asia Language: En Year: 2017 Type: Article
Fulltext
Print
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PubMed Links
Search on Google

Full text: 1 Database: MEDLINE Main subject: Reagent Kits, Diagnostic / Device Approval Type of study: Diagnostic_studies / Guideline Limits: Humans Country/Region as subject: Asia Language: En Year: 2017 Type: Article