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Implementation Rules for Compulsory Certification of Medical Device Products

  • 2018-09-19
  • 138KB
  • Points it Requires : 2

Implementation Rules for Compulsory Certification of Medical Devices 3. Basic Requirements for Certification Implementation 33.1 Application for Certification 33.2 Type Testing 43.3 Initial Factory Inspection 63.4 Evaluation and Approval of Certification Result 73.5 Post-Certification Supervision 84. Maintenance and Change of Certification Certificate 104.1 Maintenance of Certification Certificate 104.2 Change of Products Covered by Certification Certificate 105. Provisions on the Use of Certification Marks 115.1 Use of Deformed Certification Marks 115.2 Permitted Mark Styles 115.3 Application Methods 115.4 Application Locations 116. Suspension, Cancellation and Revocation of Certification 117. Fees 11 Annex 1: List of Safety Critical Components, Standards for Testing and Number of Samples 12 Annex 2: Requirements for Quality Assurance Capabilities of Compulsory Product Certification Factories 13

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