Resources

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 #NamePhaseIssued ByIssued DateDownload
MJPRC-20180825-1Amended Regulation on Supervision and Management of Medical Devices of Medical Devices (Draft)DraftMinistry of JusticeJune 25, 2018Download
Decree No.7 CFDA, 2017Measures for Supervision and Administration of Medical Device ProductionImplementedCFDANovember 21, 2017Download
Decree 4 CFDA, 2014Provisions for Medical Device RegistrationImplementedCFDAJuly 30, 2014Download

Registration/Filling

File #NamePhaseIssued ByIssued DateDownload
NMPA Medical Device Registration & Clinical Trial ProcessJuly 8, 2020Download
Notice, CMDE-20190103Operation Specification for Record Filing of Medical Device Master FilesDraftCMDEJanuary 3, 2019Download
Notice, CMDE-20190103Record Filing Requirement of Medical Device Master FilesDraftCMDEJanuary 3, 2019Download
Notice, CMDE-20190103Guideline for Record Filing of Medical Device Master Files (Draft)DraftCMDEJanuary 3, 2019Download
Notice, CMDE-20190103Announcement on Record Filling of Medical Device Master FilesDraftCMDEJanuary 3, 2019Download
Notice,No. 83, NMPA, 2018Innovation Device Approval ProcedureImplementedNMPANovember 5, 2018Download
Notice, NMPA-20180822Unique Device Itentification (UDI) Implementation Plan (draft)DraftNMPAAugust 22, 2018Download
Notice, No.131, CFDA, 2017Using Chinese Name for Registrant or File Submitter of Imported Medical DevicesImplementedCFDANovember 2, 2017Download
Decree 6, CFDA, 2014Regulation on Instructions for Use and Labels of Medical DevicesImplementedCFDAJuly 30, 2014Download

GMP/QMS

File #NamePhaseIssued ByIssued DateDownload
Notice No.101 NMPA, 2018Regulations for the Administration of Overseas Inspection of Pharmaceutical & Medical DevicesImplementedNMPADecember 26, 2018Download
Notice No.19 CFDA, 2016Good Manufacturing Practice in Class III Medical Device ManufacturersImplementedNMPAFebruary 5, 2016Download
Notice No.218 Annex 3, CFDAGood Manufacturing Practice Guidelines for Onsite Inspection of Implantable Medical DevicesImplementedCFDASeptember 25, 2015Download
Notice No. 218 Annex 2, CFDAGood Manufacturing Practice Guidelines for Onsite Inspection of Sterile Medical DevicesImplementedCFDASeptember 25, 2015Download
Notice No.218 Annex 1, CFDAGood Manufacturing Practice Guidelines for Onsite InspectionImplementedCFDASeptember 25, 2015Download
Notice, No.103, CFDA, 2015Good Manufacturing Practices on In Vitro Diagnostic ReagentsImplementedCFDAJuly 10, 2015Download
Notice, No.102, CFDA, 2015Good Manufacturing Practice for Implantable Medical DevicesImplementedCFDAJuly 10, 2015Download
Notice, No.64, CFDA, 2014Good Manufacturing Practice for Medical DevicesImplementedCFDADecember 29, 2014Download

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

File #NamePhaseIssued ByIssued DateDownload
Notice CMDE-20181122-2Technical Guideline for Comparing the Same Variety of In-vitro Diagnostic Reagents Exempted from Clinical Trials (Draft)DraftCMDENovember 22, 2018Download
Notice CMDE-20181122-1Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (Draft)DraftCMDENovember 22, 2018Download
Notice No.6, CFDA, 2018Medical Device Clinical Trial Design GuidelineImplementedCFDAJanuary 8, 2018Download
Notice No. 179, CFDA, 2017Basic Requirements for Clinical Evaluation Materials of IVD Exempted from Clinical Trial (Draft)ImplementedCFDANovember 8, 2017Download
Decree 25, CFDA, 2016Good Clinical Practice for Medical DeviceImplementedCFDA/National Health ComissionMarch 23, 2016Download

Guideline & Standard

File #NamePhaseIssued ByIssued DateDownload
Current China NMPA Clinical Pathways for Medical Device RegistrationNovember 18, 2020Download
Drug-Medical Device Combination Products in ChinaSeptember 21, 2020Download
Notice No.7, CMDE, 2019Guideline on AI-Aided SoftwareImplementedCMDEJuly 3, 2019Download
CMDE-20180814Guideline on High-throughput Sequencing Method Performance EvaluationDraftCFDAAugust 14, 2018Download
Notice No.51, Annex 2, NMPA, 2018Guideline for Clinical Trial of Soft Contact LensesImplementedNMPAJuly 5, 2018Download
Notice No.51, Annex 1, NMPA, 2018Guideline for Clinical Trial of Orthokeratology Rigid Gas Permeable (RGP) Contact LensesImplementedNMPAJuly 5, 2018Download
CMDE-20180226Technical Review Guideline on Customized Additive Manufactured (3D Printing) Medical Device (draft)DraftCMDEFebruary 26, 2018Download
Notice No.4 CFDA, 2018Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy SystemImplementedCFDAJanuary 8, 2018Download
Notice No.222, CFDA, 2017Guideline for Technical Review of Mobile Medical Device RegistrationImplementedCFDADecember 29, 2017Download
Notice No.75,CFDA, 2017Guideline of Passive Implantable Medical Device Shelf Life Registration Submitted DocumentsImplementedCFDAMay 26, 2017Download
Notice No.52,CFDA, 2017Technical Review Guideline on Fetal Chromosome Aneuploidy (T21, T18, T13) Test Kit (High-throughput Sequencing Method)ImplementedCFDAApril 1, 2017Download
YYT 1513-2017Industry Standard on C-reactive protein testing kitMarch 28, 2017Download

Post Market Surveillance (AE, Recall, etc.)

File #NamePhaseIssued ByIssued DateDownload
Decree 1 Annex 9, NMPA, 2018Guidance on Inspecting Medical Device Adverse Event Monitoring ActivityDraftNMPASeptember 20, 2018Download
Decree 1 Annex 7, NMPA, 2018Guidance on Focus Points when Monitoring Medical Device Adverse EventsDraftNMPASeptember 20, 2018Download
Decree 1 Annex 5, NMPA, 2018Guidance for License Holder on Collecting and Reporting Individual Cases of Medical Device Adverse EventDraftNMPASeptember 20, 2018Download
Decree 1 Annex 3, NMPA, 2018Guidance on Medical Device Adverse Event Monitoring ScopeDraftNMPASeptember 20, 2018Download
Decree 1 Annex 1, NMPA, 2018Guidance on Medical Device Adverse Event MonitoringDraftNMPASeptember 20, 2018Download
Decree 1, NMPA, 2018Measures for the Administration of Medical Device Adverse Event Monitoring and Re-evaluationImplementedNMPAAugust 31, 2018Download
Decree 29, NMPA, 2018Measures for the Administration of Medical Device RecallImplementedCFDAJanuary 25, 2017Download