Regulatory

Latest Regulations

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Notice on Activating the Second Page of the New Inspection Report of the China Inspection and Quarantine Institute

Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20220727 Product Type Testing 2022-07-27 2022-07-27

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

Notice of the General Office of the State Administration on Doing a Good Job in the Inspection of Medical Devices

Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2017]187号 Product Type Testing 2018-01-03 2017-12-29

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

Announcement on Carrying out Designated Inspection Work for Medical Device Registration

Regulation No. Product LifeCycle Issued Date Implemented Date CCRCFDA公告2016年第164号 Product Type Testing 2015-12-31 2016-01-01

Status Issued By Level of Legal Effect Product Category Obsolete Administrative Acceptance … Announcements IVD

Notice of the State Food and Drug Administration on Issuing Management Regulations for Designated Inspection of Medical Device Registration

Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第94号 Product Type Testing 2015-11-27 2015-11-27

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

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