Regulatory

Latest Regulations

8 Results

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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 on Publishing Key Points for Evaluation of Medical Device Software Assisted in Deep Learning Decision Making

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第7号 Product Type Testing 2019-07-03 2019-07-03

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device

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 on Relevant Issues in the Evaluation of Contact Lens Products

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20160316 Product Type Testing 2016-03-16 2016-03-16

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device

Notice on two public solicitations of opinions, including "Appendix Writing Requirements for Technical Requirements of Class III in Vitro Diagnostic Reagent Products"

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150216-f2 Product Type Testing 2015-02-16 2015-02-16

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents IVD

Notice on Two Public Soliciting Opinions, including the Writing Requirements for the Electrical Safety Part in the Technical Requirements of Electrical Equipment Products for Medical Laboratories

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20150216-f1 Product Type Testing 2015-02-16 2015-02-16

Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device

Notice on Publishing the Explanation of Chemical Performance Requirements for Interventional Medical Device Products

Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20100301 Product Type Testing 2010-03-01 2010-04-01

Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents Medical Device

Notice on Issuing Technical Requirements for High Strength Ultrasound Focused Therapy Machines

Regulation No. Product LifeCycle Issued Date Implemented Date 国食药监械[2003]222号 Product Type Testing 2003-08-26 2003-08-26

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

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