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Latest Regulations

24  Results

Notice of the State Administration on Issuing the Risk List and Inspection Points for the Production Process of 21 Medical Devices, including Disposable Plastic Blood Bags
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2017]14号 Supervision & Inspection,Manufacturing 2017-02-10 2017-02-03
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration on Issuing the Guidelines for the Quality Management of Medical Device Production and the Inspection of Customized Dentures on Site
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监〔2016〕165号 Supervision & Inspection,Manufacturing 2016-12-21 2016-12-16
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration on Further Strengthening Random Inspection of Food and Drug Safety and Strengthening Supervision During and After the Event
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20161202 Supervision & Inspection 2016-12-02 2016-11-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice of the State Administration on Issuing a Risk List and Inspection Points for the Production Process of 25 Medical Devices, including Disposable Sterile Syringes
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2016]37号 Supervision & Inspection,Manufacturing 2016-04-13 2016-04-13
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the State Administration on the Implementation of Quality Management Standards for Medical Device Production by Class III Medical Device Production Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2016年第19号 Supervision & Inspection,Manufacturing 2016-02-05 2016-02-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the General Office of the State Council on Further Strengthening the Sampling and Inspection of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2016]9号 Supervision & Inspection,Distribution 2016-02-04 2016-02-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Reply from the General Office of the Food and Drug Administration on Issues Related to the Operation of In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]646号 Supervision & Inspection,Distribution 2015-10-22 2015-10-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD Regulated as Pharmaceuticals
Opinions of the State Administration for Food and Drug Administration on Strengthening in-process and post supervision of matters related to the cancellation and delegation of administrative approvals
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监法[2015]65号 Supervision & Inspection,Product Type Testing 2015-06-09 2015-06-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the General Office of the Food and Drug Administration on Strictly Cracking down on the Illegal Operation of Decorative Colored Flat Light Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监[2015]48号 Supervision & Inspection 2015-03-30 2015-03-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice of the State Administration of Food and Drug Administration on Strengthening the Quality and Safety Management of Condoms
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]30号 Supervision & Inspection 2015-03-23 2015-03-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
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