Regulatory

Latest Regulations

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Notice of the National Medical Products Administration on Issuing the Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones

Regulation No. Product LifeCycle Issued Date Implemented Date 国药监法[2019]48号 Manufacturing,Distribution,Registration & Filing 2019-11-29 2019-11-27

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

Part 1 of the Measures for the Supervision and Administration of Medical Device Production

Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150122-1 Manufacturing 2015-01-22 2015-01-22

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

Announcement of the State Food and Drug Administration on Matters Related to the Filing of Medical Device Production and Operation

Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2014年第25号 Distribution,Manufacturing 2014-05-30 2014-05-30

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

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