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 |
|---|
| [acf_CMD_FileNumber] | Amended Regulation on Supervision and Management of Medical Devices (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | June 25, 2018 | Download |
| [acf_CMD_FileNumber] | Supervision and Administration of Medical Device Production | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 21, 2017 | Download |
| [acf_CMD_FileNumber] | Provisions for Medical Device Registration | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 30, 2014 | Download |
Registration/Filling
| File # | Name | Phase | Issued By | Issued Date | Download |
|---|
| [acf_CMD_FileNumber] | NMPA Medical Device Registration & Clinical Trial Process | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 8, 2020 | Download |
| [acf_CMD_FileNumber] | Operation Specification for Record Filing of Medical Device Master Files | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 3, 2019 | Download |
| [acf_CMD_FileNumber] | Record Filing Requirement of Medical Device Master Files | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 3, 2019 | Download |
| [acf_CMD_FileNumber] | Guideline for Record Filing of Medical Device Master Files (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 3, 2019 | Download |
| [acf_CMD_FileNumber] | Announcement on Record Filling of Medical Device Master Files | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 3, 2019 | Download |
| [acf_CMD_FileNumber] | Innovation Device Approval Procedure | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 5, 2018 | Download |
| [acf_CMD_FileNumber] | Unique Device Identification (UDI) Implementation Plan (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | August 22, 2018 | Download |
| [acf_CMD_FileNumber] | Using Chinese Name for Registrant or File Submitter of Imported Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 2, 2017 | Download |
| [acf_CMD_FileNumber] | Regulation on Instructions for Use and Labels of Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 30, 2014 | Download |
GMP/QMS
| File # | Name | Phase | Issued By | Issued Date | Download |
|---|
| [acf_CMD_FileNumber] | Regulations for Overseas Inspection of Pharmaceutical & Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | December 26, 2018 | Download |
| [acf_CMD_FileNumber] | Good Manufacturing Practice in Class III Medical Device Manufacturers | [acf_CMD_PHASE] | [acf_CMD_Issued By] | February 5, 2016 | Download |
| [acf_CMD_FileNumber] | Guidelines for Onsite Inspection of Implantable Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 25, 2015 | Download |
| [acf_CMD_FileNumber] | Good Manufacturing Guidelines for Inspection of Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 25, 2015 | Download |
| [acf_CMD_FileNumber] | Good Manufacturing Practice Guidelines for Onsite Inspection | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 25, 2015 | Download |
| [acf_CMD_FileNumber] | Good Manufacturing Practices on In Vitro Diagnostic Reagents | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 10, 2015 | Download |
| [acf_CMD_FileNumber] | Good Manufacturing Practice for Implantable Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 10, 2015 | Download |
| [acf_CMD_FileNumber] | Good Manufacturing Practice for Medical Devices | [acf_CMD_PHASE] | [acf_CMD_Issued By] | December 29, 2014 | Download |
Clinical Evaluation (Clinical Trial, CER, Overseas Clinical Data, etc.)
| File # | Name | Phase | Issued By | Issued Date | Download |
|---|
| [acf_CMD_FileNumber] | Tech Guide for Comparing the Same Variety of IVD Exempted from Trials (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 22, 2018 | Download |
| [acf_CMD_FileNumber] | Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 22, 2018 | Download |
| [acf_CMD_FileNumber] | Medical Device Clinical Trial Design Guideline | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 8, 2018 | Download |
| [acf_CMD_FileNumber] | Requirements for Clinical Evaluation of IVD Exempted from Trial (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 8, 2017 | Download |
| [acf_CMD_FileNumber] | Good Clinical Practice for Medical Device | [acf_CMD_PHASE] | [acf_CMD_Issued By] | March 23, 2016 | Download |
Guideline & Standard
| File # | Name | Phase | Issued By | Issued Date | Download |
|---|
| [acf_CMD_FileNumber] | Current China NMPA Clinical Pathways for Medical Device Registration | [acf_CMD_PHASE] | [acf_CMD_Issued By] | November 18, 2020 | Download |
| [acf_CMD_FileNumber] | Drug-Medical Device Combination Products in China | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 21, 2020 | Download |
| [acf_CMD_FileNumber] | Guideline on AI-Aided Software | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 3, 2019 | Download |
| [acf_CMD_FileNumber] | Guideline on High-throughput Sequencing Method Performance Evaluation | [acf_CMD_PHASE] | [acf_CMD_Issued By] | August 14, 2018 | Download |
| [acf_CMD_FileNumber] | Guideline for Clinical Trial of Soft Contact Lenses | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 5, 2018 | Download |
| [acf_CMD_FileNumber] | Guideline for Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses | [acf_CMD_PHASE] | [acf_CMD_Issued By] | July 5, 2018 | Download |
| [acf_CMD_FileNumber] | Tech Guide on Customized Additive Manufactured (3D Printing) Medical Device (Draft) | [acf_CMD_PHASE] | [acf_CMD_Issued By] | February 26, 2018 | Download |
| [acf_CMD_FileNumber] | Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy System | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 8, 2018 | Download |
| [acf_CMD_FileNumber] | Guideline for Technical Review of Mobile Medical Device Registration | [acf_CMD_PHASE] | [acf_CMD_Issued By] | December 29, 2017 | Download |
| [acf_CMD_FileNumber] | Guide to Passive Implantable Medical Device Shelf Life Registration | [acf_CMD_PHASE] | [acf_CMD_Issued By] | May 26, 2017 | Download |
| [acf_CMD_FileNumber] | Technical Review Guideline on Fetal Chromosome Aneuploidy Test Kit | [acf_CMD_PHASE] | [acf_CMD_Issued By] | April 1, 2017 | Download |
| [acf_CMD_FileNumber] | Industry Standard on C-reactive Protein Testing Kit | [acf_CMD_PHASE] | [acf_CMD_Issued By] | March 28, 2017 | Download |
Post Market Surveillance (AE, Recall, etc.)
| File # | Name | Phase | Issued By | Issued Date | Download |
|---|
| [acf_CMD_FileNumber] | Guide on Inspecting Medical Device Adverse Event Monitoring Activity | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 20, 2018 | Download |
| [acf_CMD_FileNumber] | Guide on Focus Points when Monitoring Medical Device Adverse Events | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 20, 2018 | Download |
| [acf_CMD_FileNumber] | Reporting Individual Cases of Medical Device Adverse Event | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 20, 2018 | Download |
| [acf_CMD_FileNumber] | Guidance on Medical Device Adverse Event Monitoring Scope | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 20, 2018 | Download |
| [acf_CMD_FileNumber] | Guidance on Medical Device Adverse Event Monitoring | [acf_CMD_PHASE] | [acf_CMD_Issued By] | September 20, 2018 | Download |
| [acf_CMD_FileNumber] | Medical Device Adverse Event Monitoring and Re-evaluation | [acf_CMD_PHASE] | [acf_CMD_Issued By] | August 31, 2018 | Download |
| [acf_CMD_FileNumber] | Measures for the Administration of Medical Device Recall | [acf_CMD_PHASE] | [acf_CMD_Issued By] | January 25, 2017 | Download |