Regulatory

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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 "Quality Management Standards for Medical Device Operations" Part 2

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231212 Supervision & Inspection,Distribution 2023-12-11 2023-12-11

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

Interpretation of the Quality Management Standards for Medical Device Operations

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231208 Supervision & Inspection,Distribution 2023-12-08 2023-12-08

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

Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2023年第153号 Supervision & Inspection,Distribution 2023-12-07 2024-07-01

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

Interpretation of the Management Measures for Medical Device Recall Part Three

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20220411-2 Distribution 2022-04-11 2022-04-11

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

Notice of the State Administration for Market Regulation on the Public Solicitation of Opinions on the Measures for the Supervision and Administration of Import Medical Device Agents (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date SAMR-20181224 Supervision & Inspection,Usage,Distribution 2018-12-25 2018-12-24

Status Issued By Level of Legal Effect Product Category Draft Ministry of … Work Documents IVD

Interpretation of the Management Measures for Medical Device Recall II

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170524 Supervision & Inspection,Distribution 2017-05-24 2017-05-24

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

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 国务院令第680号 Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing 2017-05-19 2017-05-04

Status Issued By Level of Legal Effect Product Category Obsolete State Council … Administrative Regulations IVD

Notice of the General Office of the State Council on the Implementation of the Measures for the Administration of Medical Device Recalls

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170428 Supervision & Inspection,Distribution 2017-04-28 2017-04-27

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

Interpretation of the Management Measures for Medical Device Recalls

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170208-1 Distribution 2017-02-08 2017-02-08

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

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Interpretation of "Quality Management Standards for Medical Device Operations" Part 2

Interpretation of the Quality Management Standards for Medical Device Operations

Announcement of the National Medical Products Administration on Issuing the Quality Management Standards for Medical Device Operation (No. 153 of 2023)

Interpretation of the Management Measures for Medical Device Recall Part Three

Notice of the State Administration for Market Regulation on the Public Solicitation of Opinions on the Measures for the Supervision and Administration of Import Medical Device Agents (Draft for Comments)

Interpretation of the Management Measures for Medical Device Recall II

Decision of the State Council on Amending the Regulations on the Supervision and Administration of Medical Devices

Notice of the General Office of the State Council on the Implementation of the Measures for the Administration of Medical Device Recalls

Interpretation of the Management Measures for Medical Device Recalls