Regulatory

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises in China (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20241104 Manufacturing 2024-11-04 2024-11-04

Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … UNKNOWN UNKNOWN

None

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20240828 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2024-08-28 2024-08-26

Status Issued By Level of Legal Effect Product Category Draft UNKNOWN UNKNOWN UNKNOWN

Interpretation of the Supervision and Management Regulations on the Implementation of Main Responsibility for Medical Device Quality and Safety by Enterprises

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20221230 Manufacturing 2022-12-30 2022-12-30

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device

Announcement of the National Medical Products Administration on Issuing the Supervision and Management Regulations for Enterprises to Implement the Main Responsibility of Medical Device Quality and Safety (No. 124 of 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2022年第124号 Manufacturing 2022-12-29 2022-12-29

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Notice on Issuing Guidelines for Writing Annual Self inspection Reports on Medical Device Quality Management Systems (No. 13, 2022)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2022年第13号 Manufacturing 2022-03-24 2022-02-24

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Guiding Principles for Independent Software Field Inspection of Medical Device Production Quality Management Standards

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械管[2020]57号 Manufacturing 2020-06-04 2020-05-29

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device

Notice of the National Medical Products Administration on Issuing the Basic Principles of Safety and Performance of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2020年第18号 Manufacturing 2020-03-10 2020-03-03

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Interpretation of the Rules for the Unique Identification System of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190827-1 Usage,Distribution,Manufacturing 2019-08-27 2019-08-27

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD

Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第66号 Usage,Distribution,Manufacturing 2019-08-27 2019-10-01

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD

Notice from the National Medical Products Administration on the Release of Independent Software for the Appendix of Medical Device Production Quality Management Standards

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2019年第43号 Manufacturing 2019-07-12 2019-07-05

Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device

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The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises in China (Draft for Comments)

None

Interpretation of the Supervision and Management Regulations on the Implementation of Main Responsibility for Medical Device Quality and Safety by Enterprises

Announcement of the National Medical Products Administration on Issuing the Supervision and Management Regulations for Enterprises to Implement the Main Responsibility of Medical Device Quality and Safety (No. 124 of 2022)

Notice on Issuing Guidelines for Writing Annual Self inspection Reports on Medical Device Quality Management Systems (No. 13, 2022)

Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Guiding Principles for Independent Software Field Inspection of Medical Device Production Quality Management Standards

Notice of the National Medical Products Administration on Issuing the Basic Principles of Safety and Performance of Medical Devices

Interpretation of the Rules for the Unique Identification System of Medical Devices

Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices

Notice from the National Medical Products Administration on the Release of Independent Software for the Appendix of Medical Device Production Quality Management Standards