Regulatory

Notice on Enabling Electronic Reports for Medical Device Registration and Inspection

Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20211217 Product Type Testing 2021-12-17 2021-12-17

Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents IVD

Interpretation of the Regulations on Self inspection Management of Medical Device Registration

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211027 Product Type Testing 2021-10-27 2021-10-27

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 the Regulations on Self inspection Management of Medical Device Registration (No. 126 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第126号 Product Type Testing 2021-10-22 2021-10-21

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

Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第739号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2021-03-18 2021-06-01

Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN

Announcement of the National Medical Products Administration on Issuing the Medical Device Industry Standard "General Technical Requirements for Oral Collagen Membranes" (No. 39 of 2021)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第39号 Product Type Testing 2021-03-16 2022-04-01

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

Forwarding Notice on Soliciting Opinions on the Recommended National Standard (Draft for Comments) for the Application of Medical Device Quality Management System in Regulations

Regulation No. Product LifeCycle Issued Date Implemented Date 国质管标〔2021〕3号 Product Type Testing 2021-01-11 2022-01-11

Status Issued By Level of Legal Effect Product Category Draft Center for … Normative Documents IVD

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the standardization of medical devices (draft for soliciting opinions)

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20201231 Product Type Testing 2020-12-31 2020-12-31

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

Notice of the Comprehensive Department of the National Medical Products Administration on Clarifying Matters Related to the Labeling of Qualification Identification Marks in the Medical Device Inspection Work Standards

Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函〔2020〕746号 Product Type Testing 2020-12-08 2020-12-03

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

Announcement of the National Medical Products Administration on the Release of 34 Medical Device Industry Standards, including YY0341.1-2020 "Passive Surgical Implants - Bone Joining and Spinal Implants - Part 1: Special Requirements for Bone Joining Implants"

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第108号 Product Type Testing 2020-10-21 2020-09-27

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

Announcement of the National Medical Products Administration on the Release of 41 Medical Device Industry Standards and 2 Amendment Orders, including YY0485-2020 "Disposable Cardiac Arrest Infusion Device"

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年76号 Product Type Testing 2020-07-09 2020-06-30

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

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Notice on Enabling Electronic Reports for Medical Device Registration and Inspection

Interpretation of the Regulations on Self inspection Management of Medical Device Registration

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

Regulations on the Supervision and Administration of Medical Devices

Announcement of the National Medical Products Administration on Issuing the Medical Device Industry Standard "General Technical Requirements for Oral Collagen Membranes" (No. 39 of 2021)

Forwarding Notice on Soliciting Opinions on the Recommended National Standard (Draft for Comments) for the Application of Medical Device Quality Management System in Regulations

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on further strengthening the standardization of medical devices (draft for soliciting opinions)

Notice of the Comprehensive Department of the National Medical Products Administration on Clarifying Matters Related to the Labeling of Qualification Identification Marks in the Medical Device Inspection Work Standards

Announcement of the National Medical Products Administration on the Release of 34 Medical Device Industry Standards, including YY0341.1-2020 "Passive Surgical Implants - Bone Joining and Spinal Implants - Part 1: Special Requirements for Bone Joining Implants"

Announcement of the National Medical Products Administration on the Release of 41 Medical Device Industry Standards and 2 Amendment Orders, including YY0485-2020 "Disposable Cardiac Arrest Infusion Device"