NMPA (CFDA) English Regulations

NMPA (CFDA) English Regulations

China Med Device provide complementary English copy of China NMPA (CFDA) regulations, including: General Decrees, Registration/Filing, GMP/QMS, Clinical Evaluation, Guideline & Standard, PMS, etc

General Decree

File # Name Phase Issued By Issued Date Download
MJPRC-20180825-1 Amended Regulation on Supervision and Management of Medical Devices of Medical Devices (Draft) Draft Ministry of Justice June 25, 2018 Download
Decree No.7 CFDA, 2017 Measures for Supervision and Administration of Medical Device Production Implemented CFDA November 21, 2017 Download
Decree 4 CFDA, 2014 Provisions for Medical Device Registration Implemented CFDA July 30, 2014 Download

    Registration/Filling

    File # Name Phase Issued By Issued Date Download
    NMPA Medical Device Registration & Clinical Trial Process July 8, 2020 Download
    Notice, CMDE-20190103 Operation Specification for Record Filing of Medical Device Master Files Draft CMDE January 3, 2019 Download
    Notice, CMDE-20190103 Record Filing Requirement of Medical Device Master Files Draft CMDE January 3, 2019 Download
    Notice, CMDE-20190103 Guideline for Record Filing of Medical Device Master Files (Draft) Draft CMDE January 3, 2019 Download
    Notice, CMDE-20190103 Announcement on Record Filling of Medical Device Master Files Draft CMDE January 3, 2019 Download
    Notice,No. 83, NMPA, 2018 Innovation Device Approval Procedure Implemented NMPA November 5, 2018 Download
    Notice, NMPA-20180822 Unique Device Itentification (UDI) Implementation Plan (draft) Draft NMPA August 22, 2018 Download
    Notice, No.131, CFDA, 2017 Using Chinese Name for Registrant or File Submitter of Imported Medical Devices Implemented CFDA November 2, 2017 Download
    Decree 6, CFDA, 2014 Regulation on Instructions for Use and Labels of Medical Devices Implemented CFDA July 30, 2014 Download

      GMP/QMS

      File # Name Phase Issued By Issued Date Download
      Notice No.101 NMPA, 2018 Regulations for the Administration of Overseas Inspection of Pharmaceutical & Medical Devices Implemented NMPA December 26, 2018 Download
      Notice No.19 CFDA, 2016 Good Manufacturing Practice in Class III Medical Device Manufacturers Implemented NMPA February 5, 2016 Download
      Notice No.218 Annex 3, CFDA Good Manufacturing Practice Guidelines for Onsite Inspection of Implantable Medical Devices Implemented CFDA September 25, 2015 Download
      Notice No. 218 Annex 2, CFDA Good Manufacturing Practice Guidelines for Onsite Inspection of Sterile Medical Devices Implemented CFDA September 25, 2015 Download
      Notice No.218 Annex 1, CFDA Good Manufacturing Practice Guidelines for Onsite Inspection Implemented CFDA September 25, 2015 Download
      Notice, No.103, CFDA, 2015 Good Manufacturing Practices on In Vitro Diagnostic Reagents Implemented CFDA July 10, 2015 Download
      Notice, No.102, CFDA, 2015 Good Manufacturing Practice for Implantable Medical Devices Implemented CFDA July 10, 2015 Download
      Notice, No.64, CFDA, 2014 Good Manufacturing Practice for Medical Devices Implemented CFDA December 29, 2014 Download

        Clinical Evaluation (Clinical Trial, CER, Overseas Clinical Data, etc.)

        File # Name Phase Issued By Issued Date Download
        Notice CMDE-20181122-2 Technical Guideline for Comparing the Same Variety of In-vitro Diagnostic Reagents Exempted from Clinical Trials (Draft) Draft CMDE November 22, 2018 Download
        Notice CMDE-20181122-1 Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (Draft) Draft CMDE November 22, 2018 Download
        Notice No.6, CFDA, 2018 Medical Device Clinical Trial Design Guideline Implemented CFDA January 8, 2018 Download
        Notice No. 179, CFDA, 2017 Basic Requirements for Clinical Evaluation Materials of IVD Exempted from Clinical Trial (Draft) Implemented CFDA November 8, 2017 Download
        Decree 25, CFDA, 2016 Good Clinical Practice for Medical Device Implemented CFDA/National Health Comission March 23, 2016 Download

          Guideline & Standard

          File # Name Phase Issued By Issued Date Download
          Drug-Medical Device Combination Products in China September 21, 2020 Download
          Notice No.7, CMDE, 2019 Guideline on AI-Aided Software Implemented CMDE July 3, 2019 Download
          CMDE-20180814 Guideline on High-throughput Sequencing Method Performance Evaluation Draft CFDA August 14, 2018 Download
          Notice No.51, Annex 2, NMPA, 2018 Guideline for Clinical Trial of Soft Contact Lenses Implemented NMPA July 5, 2018 Download
          Notice No.51, Annex 1, NMPA, 2018 Guideline for Clinical Trial of Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses Implemented NMPA July 5, 2018 Download
          CMDE-20180226 Technical Review Guideline on Customized Additive Manufactured (3D Printing) Medical Device (draft) Draft CMDE February 26, 2018 Download
          Notice No.4 CFDA, 2018 Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy System Implemented CFDA January 8, 2018 Download
          Notice No.222, CFDA, 2017 Guideline for Technical Review of Mobile Medical Device Registration Implemented CFDA December 29, 2017 Download
          Notice No.75,CFDA, 2017 Guideline of Passive Implantable Medical Device Shelf Life Registration Submitted Documents Implemented CFDA May 26, 2017 Download
          Notice No.52,CFDA, 2017 Technical Review Guideline on Fetal Chromosome Aneuploidy (T21, T18, T13) Test Kit (High-throughput Sequencing Method) Implemented CFDA April 1, 2017 Download
          YYT 1513-2017 Industry Standard on C-reactive protein testing kit March 28, 2017 Download
          Notice No.14,CFDA, 2017 Technical Review Guideline for Registration of Calcium Phosphate/Silicone Bone Filling Materials Implemented CFDA February 10, 2017 Download
          Notice No. 28, CFDA, 2016 C-reactive Protein Assay Kit Registration Technical review guideline Implemented CFDA March 3, 2016 Download
          Notice No.50, CFDA, 2015 Guideline for Technical Review of Medical Device Software Registration Implemented CFDA August 18, 2015 Download
          GB/T 4340.1—2009 Metal Materials- Vickers Hardness Test Part 1 Test Method June 25, 2009 Download
          Notice No.345, CFDA , 2007 Review Guideline on Biological Evaluation for Medical Devices Implemented CFDA June 15, 2007 Download

            Post Market Surveillance (AE, Recall, etc.)

            File # Name Phase Issued By Issued Date Download
            Decree 1 Annex 9, NMPA, 2018 Guidance on Inspecting Medical Device Adverse Event Monitoring Activity Draft NMPA September 20, 2018 Download
            Decree 1 Annex 7, NMPA, 2018 Guidance on Focus Points when Monitoring Medical Device Adverse Events Draft NMPA September 20, 2018 Download
            Decree 1 Annex 5, NMPA, 2018 Guidance for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse Event Draft NMPA September 20, 2018 Download
            Decree 1 Annex 3, NMPA, 2018 Guidance on Medical Device Adverse Event Monitoring Scope Draft NMPA September 20, 2018 Download
            Decree 1 Annex 1, NMPA, 2018 Guidance on Medical Device Adverse Event Monitoring Draft NMPA September 20, 2018 Download
            Decree 1, NMPA, 2018 Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluation Implemented NMPA August 31, 2018 Download
            Decree 29, NMPA, 2018 Measures for the Administration of Medical Device Recall Implemented CFDA January 25, 2017 Download