1

Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 739)

1

Administrative Measures for the Registration and Filing of Medical Devices ( State Administration for Market Regulation Order No. 47)

2

Administrative Measures for the Registration and Filing of In Vitro Diagnostic Reagents (State Administration for Market Regulation Order No. 48)

3

Provisions on the Administration of Instructions and Labels of Medical Devices (China Food and Drug Administration Order No. 6)

4

Administrative Measures for the Supervision and Management of Medical Device Production (State Administration for Market Regulation Order No. 53)

5

Measures for the Supervision and Administration of Medical Device Businesses (State Administration for Market Regulation Order No. 54)

6

Measures for Flight Inspection of Drugs and Medical Devices (China Food and Drug Administration Order No. 14)

7

Measures for the Supervision and Administration of the Quality of Medical Device Use (China Food and Drug Administration Order No. 18)

8

Rules for Naming Medical Device Common Names (China Food and Drug Administration Order No. 19)

9

Announcement of the National Medical Products Administration and National Health Commission on the Publication of the Quality Management Standards for Clinical Trials of Medical Devices (No. 28 of 2022)

10

Measures for Administration of the Recall of Medical Devices (China Food and Drug Administration Order No. 29)

11

Decision of the China Food and Drug Administration on Adjusting the Approval Procedures for Some Medical Device Administrative Approval Matters (China Food and Drug Administration Order No. 32)

12

Measures for the Administration of Medical Device Standards (China Food and Drug Administration Order No. 33)

13

Measures for the Supervision and Administration of Online Sales of Medical Devices (China Food and Drug Administration Order No. 38)

14

Measures for the Administration of Monitoring and Re-evaluation of Adverse Events of Medical Devices (State Administration for Market Regulation Order No. 1 + A14: B28)

1

Notice of the National Medical Products Administration on Implementing the "Regulations for Clinical Trial Quality Management of Medical Devices" (No. 21 of 2022)

2

Notice on the Issuing of the guidelines for the design of clinical trials of medical devices (No. 6 of 2018)

3

Notice on Issuing Technical Guidelines for Accepting Overseas Clinical Trial Data of Medical Devices (No. 13 of 2018)

4

Notice of the National Medical Products Administration on Issuing the Catalogue of Class III Medical Devices Requiring Clinical Trial Approval (2020 Revision) (No. 61 of 2020)

5

Notice of the National Medical Products Administration on Issuing the Catalogue of In-Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 70 of 2021)

6

Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 71 of 2021)

7

Notice of the National Medical Products Administration on Issuing Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (No. 72 of 2021)

8

Notice of the National Medical Products Administration on Issuing 5 Technical Guidelines for Clinical Evaluation of Medical Devices (No. 73 of 2021)

9

Notice of the National Medical Products Administration on Issuing Technical Guidelines for Clinical Evaluation of In-Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 74 of 2021)

10

Notice of the National Medical Products Administration on Issuing Two Registration Review Guidelines for the Requirements for Submitting Clinical Trial Data of Medical Devices (No. 91 of 2021)

11

Announcement of the National Medical Products Administration and National Health Commission on the Issuance of the Regulations on the Management of Expanded Clinical Trials of Medical Devices (Trial Implementation) (No. 41 of 2020)

1

Notice on the issuance of the Guidelines for the Naming of General Names of Medical Devices (No. 99 of 2019)

2

Announcement on the Requirements for the Release of Medical Device Registration Application Materials and the Format of Approval Documents (No. 121 of 2021)

3

Announcement on the Requirements for the Release of Registration Application Materials for In Vitro Diagnostic Reagents and the Format of Approval Documents (No. 122 of 2021)

4

Announcement of the National Medical Products Administration on the Comprehensive Implementation of Electronic Registration Certificates for Medical Devices (No. 91 of 2022)

5

Notice of the National Medical Products Administration on Issuing the Guidelines for Verification of Quality Management System for Medical Device Registration (No. 50 of 2022)

6

Notice of the National Medical Products Administration on Issuing the Requirements for Filing and Examination of Medical Device Registration Projects and Other Documents (No. 40 of 2022)

7

Announcement of the National Medical Products Administration on the Registration of Class I Medical Devices (No. 62 of 2022)

8

Notice of the General Department of the National Medical Products Administration on Issuing the Verification Procedures for the Quality Management System of Registration of Class III Medical Devices in China (Y.J.Z.X.Z [2022] No. 13)

9

Announcement of the National Medical Products Administration on the Release of the First Class Medical Device Product Catalog (No. 158 of 2021)

10

Announcement of the National Medical Products Administration on Issuing the Emergency Approval Procedures for Medical Devices (No. 157 of 2021)

11

Notice of the National Medical Products Administration on Issuing the Operation Regulations for Registration and Approval of Domestic Class III and Imported Medical Devices (G.Y.J.X.Z. [2021] No. 53)

12

Notice of the National Medical Products Administration on Issuing the Operation Specifications for Registration and Approval of Class II Medical Devices in China (G.Y.J.X.Z. [2021] No. 54)

13

Announcement of the National Medical Products Administration on the Release of the Classification Rules for In Vitro Diagnostic Reagents (No. 129 of 2021)

14

Announcement of the National Medical Products Administration on Issuing the "Regulations on Self-Inspection Management of Medical Device Registration" (No. 126 of 2021)

15

Notice of the National Medical Products Administration on Matters Relating to the Registration of Combined Products of Pharmaceuticals and Medical Devices (No. 52 of 2021)

16

Announcement of the National Medical Products Administration on the Dynamic Adjustment Procedures for the Classification Catalogue of Medical Devices (No. 60 of 2021)

17

Announcement of the National Medical Products Administration on Registration Matters of Medical Device Master Documents (No. 36 of 2021)

18

Notice of the National Medical Products Administration on Issuing the Basic Principles of Medical Device Safety and Performance (No. 18 of 2020)

1

Announcement on Issuing the Regulations for Production Quality Management of Medical Devices (No. 64 of 2014)

2

Notice on Issuing the Guidelines for Reviewing Suppliers of Medical Device Manufacturers (No. 1 of 2015)

3

Announcement on the Publication of the Appendix to the Good Manufacturing Practice for Medical Devices for Sterile Medical Devices (No. 101 of 2015)

4

Announcement on the Publication of the Appendix to the Good Manufacturing Practice for Medical Devices for Sterile Medical Devices (No. 101 of 2015)

5

Announcement on the Publication of In Vitro Diagnostic Reagents Appendix to the Good Manufacturing Practice for Medical Devices (No. 103 of 2015)

6

Announcement of the General Administration of Quality Supervision, Inspection and Quarantine on Issuing the Appendix of Customized Dentures to the Medical Device Production Quality Management Regulations (No. 195 of 2016)

7

Notice on Issuing 4 Guiding Principles for On-site Inspection of the Production Quality Management Standards for Medical Devices (SYJXJ [2015] No. 218)

8

Notice on Issuing the Guidelines for Preparing the Annual Self-inspection Report on the Quality Management System of Medical Devices (No. 13 of 2022)

9

Notice on Issuing the Management Guide for the Management Representative of Medical Device Manufacturing Enterprises (No. 96 of 2018)

10

Notice on Printing and Distributing the Guidelines for On-site Inspection of Independent Software for the Production Quality Management Regulations for Medical Devices (YJZMXG [2020] No. 57)

11

Notice of the National Medical Products Administration on Issuing the Guidelines for Preparing Quality Agreements for Entrusted Production of Medical Devices (No. 20 of 2022)

12

Notice of the National Medical Products Administration on Issuing the Catalogue of Banned Entrusted Production of Medical Devices (No. 17 of 2022)

13

Notice of the National Medical Products Administration on Issuing the Writing Standards for Periodic Risk Assessment Reports of Medical Devices (No. 46 of 2020)

14

Notice of the General Department of the National Medical Products Administration on Issuing the Guiding Principles for On-site Inspection of Independent Software for the Production Quality Management Regulations for Medical Devices (YJZMXG [2020] No. 57)

15

Notice of the General Administration on Issuing the Guidelines for Quality Control and Finished Product Release of Medical Device Manufacturers (No. 173 of 2016)

1

Notice on Issuing the Guiding Principles for On-site Inspection of the Quality Management Standards for Medical Device Operation (SYJXJ [2015] No. 239)

2

Announcement on Issuing the Management Guidelines for Cold Chain (Transportation and Storage) of Medical Devices (No. 154 of 2016)

3

Notice on the Measures for Implementation of the Supervision and Administration of Online Sales of Medical Devices (SYJBFJ [2018] No. 31)

4

Announcement of the National Medical Products Administration on the Publication of the Catalogue of Class II Medical Device Products Exempted from Operation Registration (No. 86 of 2021)

5

Announcement of the National Medical Products Administration on Issuing the "Appendix to the Quality Management Standards for Medical Device Operation: Quality Management of Enterprises Specializing in Providing Medical Device Transportation and Storage Services" (No. 94 of 2022)

1

Metrology Law of the People's Republic of China

2

Measures for Special Equipment Safety Supervisory Inspections (State Administration for Market Regulation Order No. 57)

3

Measures for the Administration of the Clinical Use of Medical Devices (National Health Commission Order No. 8)

4

Notice on Issuing the Administrative Measures for Medical Consumables in Medical Institutions (Trial) (GWYF [2019] No. 43)

5

Notice on Issuing the Administrative Measures for the Configuration and Use of Large-scale Medical Equipment (Trial) (GWPH [2018] No. 12)

6

Notice of the General Office of the National Health Commission on Issuing the First Batch of Key Management Lists of National High-value Medical Consumables (GWBYH [2020] No. 9)

7

Notice on Printing and Distributing the Key Points of Correcting Unhealthy Practices in the Field of Pharmaceutical Purchasing and Sale and Medical Services in 2021 (GWYH [2021] No. 85)

8

Notice of the Office of the Guangdong Provincial Health and Family Planning Commission on Issuing the "Guangdong Provincial Medical Institution Medical Consumables Procurement Internal Management Guidelines (Trial)"

9

Notice of the seven departments including Guangzhou Medical Security Bureau on issuing the implementation plan for centralized procurement of medical consumables in Guangzhou medical institutions (SGMF [2020] No. 23)

1

Notice of the General Administration on Issuing the Guidelines for Preparing the Application Materials for Priority Approval of Medical Devices (Trial) (No. 28 of 2017)

2

Announcement of the National Medical Products Administration on the Special Review Procedure for Innovative Medical Devices (No. 83 of 2018)

3

Notice of the National Medical Products Administration on Issuing the Administrative Measures for Quality Inspection of Medical Devices (G.Y.J.X.G. [2020] No. 9)

4

Notice on Issuing the Guidance for Medical Device Registrants to Conduct Adverse Event Monitoring (No. 25 of 2020)

5

Guiding Opinions of the General Department of the National Medical Products Administration on Strengthening the Grading Supervision of Medical Device Production and Operation (CFDA ZXG [2022] No. 78)

6

Announcement of the National Medical Products Administration and the National Health Commission on the Issuance of the Regulations on the Supervision and Administration of Customized Medical Devices (Trial Implementation) (No. 53 of 2019)

7

Announcement on the Release of the Rules for the Unique Identification System for Medical Devices (No. 66 of 2019)

8

Notice of the General Department of the National Medical Products Administration on Carrying out the Risk Identification and Management of Medical Device Quality and Safety (YJZGXG han [2021] No. 181)

9

Announcement of the National Medical Products Administration on Issuing the "Regulations on the Supervision and Management of Enterprises' Implementation of the Main Responsibilities for Quality and Safety of Medical Devices" (No. 124 of 2022)