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Issuance date

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  • before2008

RegDoc.

  • Main Enabling Legislation
  • Registration
  • Classification
  • Manufacture
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  • Use
  • Import/Export
  • QMS
  • Clinical Verification
  • Labeling/Packaging
  • Adverse Event Monitoring
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  • Administrative Supervision
  • Medical Device Inventory
  • Regulations
  • 2014 Manufacture
  • Administrative Measures for the Supervision of Medical Device Manufacturing (CFDA Order No. 7 2014)
  • 2014 Manufacture
  • The Management Provisions for Medical Device Manufacturing Enterprise Classification(CFDA notice No. 234 2014)
  • 2015 Manufacture
  • The guide on supplier audit for Medical Device Manufacturing Enterprise(CFDA Announcement No.1 2015)
  • 2012 Manufacture
  • Working procedure on unannounced inspection for medical Device Manufacturing Enterprise( SFDA notice No.153 2012)
  • 2014 Manufacture
  • Announcement of Relevant Issues on Implementing Provisions for Medical Device Manufacture and Provisions for Medical Device (CFDA Announcement No.143 2014)
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