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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
[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