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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 # Name Phase Issued By Issued Date Download
MJPRC-2018-08-25-1 Amended Regulation on Supervision and Management of Medical Devices (Draft) Draft Ministry of Justice June 25, 2018 Download
Decree No.7 CFDA, 2017 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-2019-01-03 Operation Specification for Record Filing of Medical Device Master Files Draft CMDE January 3, 2019 Download
Notice, CMDE-2019-01-03 Record Filing Requirement of Medical Device Master Files Draft CMDE January 3, 2019 Download
Notice, CMDE-2019-01-03 Guideline for Record Filing of Medical Device Master Files (Draft) Draft CMDE January 3, 2019 Download
Notice, CMDE-2019-01-03 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-2018-08-22 Unique Device Identification (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 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 Guidelines for Onsite Inspection of Implantable Medical Devices Implemented CFDA September 25, 2015 Download
Notice No. 218 Annex 2, CFDA Good Manufacturing Guidelines for Inspection of 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-2018-11-22-2 Tech Guide for Comparing the Same Variety of IVD Exempted from Trials (Draft) Draft CMDE November 22, 2018 Download
Notice CMDE-2018-11-22-1 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 Requirements for Clinical Evaluation of IVD Exempted from Trial (Draft) Implemented CFDA November 8, 2017 Download
Decree 25, CFDA, 2016 Good Clinical Practice for Medical Device Implemented CFDA / Natl Health Comm March 23, 2016 Download

Guideline & Standard

File # Name Phase Issued By Issued Date Download
Current China NMPA Clinical Pathways for Medical Device Registration November 18, 2020 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-2018-08-14 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 Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses Implemented NMPA July 5, 2018 Download
CMDE-2018-02-26 Tech Guide 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 Guide to Passive Implantable Medical Device Shelf Life Registration Implemented CFDA May 26, 2017 Download
Notice No.52, CFDA, 2017 Technical Review Guideline on Fetal Chromosome Aneuploidy Test Kit Implemented CFDA April 1, 2017 Download
YYT 1513-2017 Industry Standard on C-reactive Protein Testing Kit March 28, 2017 Download

Post Market Surveillance (AE, Recall, etc.)

File # Name Phase Issued By Issued Date Download
Decree 1 Annex 9, NMPA, 2018 Guide on Inspecting Medical Device Adverse Event Monitoring Activity Draft NMPA September 20, 2018 Download
Decree 1 Annex 7, NMPA, 2018 Guide on Focus Points when Monitoring Medical Device Adverse Events Draft NMPA September 20, 2018 Download
Decree 1 Annex 5, NMPA, 2018 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 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