Register for Upcoming Webinar on DEC. 8 @ 11AM

2023年中国药监局NMPA蓝皮书已发布:

Resources

Resources

Get Updated

Receive Updates in Your Inbox

CMD Blog

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 25 6 月, 2018 下载
Decree No.7 CFDA, 2017 Supervision and Administration of Medical Device Production Implemented CFDA 21 11 月, 2017 下载
Decree 4 CFDA, 2014 Provisions for Medical Device Registration Implemented CFDA 30 7 月, 2014 下载

Registration/Filling

File # Name Phase Issued By Issued Date Download
NMPA Medical Device Registration & Clinical Trial Process 8 7 月, 2020 下载
Notice, CMDE-2019-01-03 Operation Specification for Record Filing of Medical Device Master Files Draft CMDE 3 1 月, 2019 下载
Notice, CMDE-2019-01-03 Record Filing Requirement of Medical Device Master Files Draft CMDE 3 1 月, 2019 下载
Notice, CMDE-2019-01-03 Guideline for Record Filing of Medical Device Master Files (Draft) Draft CMDE 3 1 月, 2019 下载
Notice, CMDE-2019-01-03 Announcement on Record Filling of Medical Device Master Files Draft CMDE 3 1 月, 2019 下载
Notice, No. 83, NMPA, 2018 Innovation Device Approval Procedure Implemented NMPA 5 11 月, 2018 下载
Notice, NMPA-2018-08-22 Unique Device Identification (UDI) Implementation Plan (Draft) Draft NMPA 22 8 月, 2018 下载
Notice, No.131, CFDA, 2017 Using Chinese Name for Registrant or File Submitter of Imported Medical Devices Implemented CFDA 2 11 月, 2017 下载
Decree 6, CFDA, 2014 Regulation on Instructions for Use and Labels of Medical Devices Implemented CFDA 30 7 月, 2014 下载

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 26 12 月, 2018 Download
Notice No.19 CFDA, 2016 Good Manufacturing Practice in Class III Medical Device Manufacturers Implemented NMPA 5 2 月, 2016 下载
Notice No.218 Annex 3, CFDA Guidelines for Onsite Inspection of Implantable Medical Devices Implemented CFDA 25 9 月, 2015 下载
Notice No. 218 Annex 2, CFDA Good Manufacturing Guidelines for Inspection of Medical Devices Implemented CFDA 25 9 月, 2015 下载
Notice No.218 Annex 1, CFDA Good Manufacturing Practice Guidelines for Onsite Inspection Implemented CFDA 25 9 月, 2015 下载
Notice, No.103, CFDA, 2015 Good Manufacturing Practices on In Vitro Diagnostic Reagents Implemented CFDA 10 7 月, 2015 下载
Notice, No.102, CFDA, 2015 Good Manufacturing Practice for Implantable Medical Devices Implemented CFDA 10 7 月, 2015 下载
Notice, No.64, CFDA, 2014 Good Manufacturing Practice for Medical Devices Implemented CFDA 29 12 月, 2014 下载

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 22 11 月, 2018 下载
Notice CMDE-2018-11-22-1 Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (Draft) Draft CMDE 22 11 月, 2018 下载
Notice No.6, CFDA, 2018 Medical Device Clinical Trial Design Guideline Implemented CFDA 8 1 月, 2018 下载
Notice No. 179, CFDA, 2017 Requirements for Clinical Evaluation of IVD Exempted from Trial (Draft) Implemented CFDA 8 11 月, 2017 下载
Decree 25, CFDA, 2016 Good Clinical Practice for Medical Device Implemented CFDA / Natl Health Comm 23 3 月, 2016 下载

Guideline & Standard

File # Name Phase Issued By Issued Date Download
Current China NMPA Clinical Pathways for Medical Device Registration 18 11 月, 2020 下载
Drug-Medical Device Combination Products in China 21 9 月, 2020 下载
Notice No.7, CMDE, 2019 Guideline on AI-Aided Software Implemented CMDE 3 7 月, 2019 下载
CMDE-2018-08-14 Guideline on High-throughput Sequencing Method Performance Evaluation Draft CFDA 14 8 月, 2018 下载
Notice No.51, Annex 2, NMPA, 2018 Guideline for Clinical Trial of Soft Contact Lenses Implemented NMPA 5 7 月, 2018 下载
Notice No.51, Annex 1, NMPA, 2018 Guideline for Orthokeratology Rigid Gas Permeable (RGP) Contact Lenses Implemented NMPA 5 7 月, 2018 下载
CMDE-2018-02-26 Tech Guide on Customized Additive Manufactured (3D Printing) Medical Device (Draft) Draft CMDE 26 2 月, 2018 下载
Notice No.4 CFDA, 2018 Guidance for Clinical Evaluation of Proton/Carbon Ion Therapy System Implemented CFDA 8 1 月, 2018 下载
Notice No.222, CFDA, 2017 Guideline for Technical Review of Mobile Medical Device Registration Implemented CFDA 29 12 月, 2017 下载
Notice No.75, CFDA, 2017 Guide to Passive Implantable Medical Device Shelf Life Registration Implemented CFDA 26 5 月, 2017 下载
Notice No.52, CFDA, 2017 Technical Review Guideline on Fetal Chromosome Aneuploidy Test Kit Implemented CFDA 1 4 月, 2017 下载
YYT 1513-2017 Industry Standard on C-reactive Protein Testing Kit 28 3 月, 2017 下载

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 20 9 月, 2018 下载
Decree 1 Annex 7, NMPA, 2018 Guide on Focus Points when Monitoring Medical Device Adverse Events Draft NMPA 20 9 月, 2018 下载
Decree 1 Annex 5, NMPA, 2018 Reporting Individual Cases of Medical Device Adverse Event Draft NMPA 20 9 月, 2018 下载
Decree 1 Annex 3, NMPA, 2018 Guidance on Medical Device Adverse Event Monitoring Scope Draft NMPA 20 9 月, 2018 下载
Decree 1 Annex 1, NMPA, 2018 Guidance on Medical Device Adverse Event Monitoring Draft NMPA 20 9 月, 2018 下载
Decree 1, NMPA, 2018 Medical Device Adverse Event Monitoring and Re-evaluation Implemented NMPA 31 8 月, 2018 下载
Decree 29, NMPA, 2018 Measures for the Administration of Medical Device Recall Implemented CFDA 25 1 月, 2017 下载