Implementation Progress

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Medical Device Administrative Control System

Implementation Progress

Implementation Progress

  • Phase I: Listing of Class IV general medical devices (commence on 26 November 2004)
  • Phase II: Listing of Class II and Class III general medical devices (commence on 14 November 2005)
  • Phase III: Implementation of Conformity Assessment Body (CAB) Recognition Scheme (commence on 13 October 2006)
  • Phase IV: Listing of local manufacturers of medical devices (commence on 23 March 2007)
  • Phase V: Listing of importers of medical devices (commence on 17 July 2007)
  • Phase VI: Listing of Class D in vitro diagnostic (IVD) medical devices (commence on 1 December 2009)
  • Phase VII: Listing of distributors of medical devices (commence on 30 April 2015)
  • Phase VIII: Listing of Class B and Class C in vitro diagnostic (IVD) medical devices (commence on 11 February 2019)
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