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

Notice of the National Medical Products Administration on Issuing the Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监法〔2024〕11号 Supervision & Inspection 2024-02-23 2024-08-01

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

The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration (Draft for Comments)"

Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20231019 Supervision & Inspection 2023-10-19 2023-10-19

Status Issued By Level of Legal Effect Product Category Draft 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

Notice of the National Medical Products Administration on Handling Matters for Medical Device Operating Enterprises to Set up Warehouse Across Administrative Regions

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局通告2018年第108号 Supervision & Inspection,Distribution 2018-10-31 2019-01-01

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

The State Administration for Food and Drug Administration and the Ministry of Public Security have issued a notice on increasing the enforcement of food and drug safety and strictly implementing the provisions of punishing individuals for illegal acts of food and drug

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法[2018]12号 Supervision & Inspection 2018-01-24 2018-01-24

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

Notice of the State Administration on Issuing the Implementation Rules for Information Disclosure of Food and Drug Administrative Penalty Cases

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监稽[2017]121号 Supervision & Inspection 2017-12-28 2018-03-01

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

Notice of the State Administration on Public Solicitation of Opinions on the Evidence Rules for Food and Drug Supervision and Enforcement (Draft for Comments)

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20171207-8 Supervision & Inspection 2017-12-07 2017-12-07

Status Issued By Level of Legal Effect Product Category Draft 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

Letter on Soliciting Opinions on the Draft Measures for Investigating and Punishing Illegal Acts in the Operation of Online Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监便函[2017]30号 Supervision & Inspection,Distribution 2017-03-29 2017-03-27

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

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