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 |
