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Latest Regulations

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Reply from the General Office of the State Council on Issues Related to the Suspected Operation of Unregistered Elastomer Impression Materials
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管函[2016]534号 Supervision & Inspection,Distribution 2016-07-26 2016-07-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative 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 Manufacturing,Supervision & Inspection 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 Manufacturing,Supervision & Inspection 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
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
Notice of the State Administration for Food and Drug Administration, the Ministry of Public Security, the Supreme People's Court, the Supreme People's Procuratorate, and the Food Safety Office of the State Council on Issuing the Measures for the Connection between Food and Drug Administrative Law Enforcement and Criminal Justice
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监稽[2015]271号 Supervision & Inspection 2015-12-22 2015-12-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration for Food and Drug Administration, the Ministry of Public Security, the Supreme People's Court, the Supreme People's Procuratorate, and the Food Safety Office of the State Council on Issuing the Measures for the Connection between Food and Drug Administrative Law Enforcement and Criminal Justice
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监稽[2015]271号 Supervision & Inspection 2015-12-22 2015-12-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the State Administration of Food and Drug Administration on Issuing the Qualification Recognition Conditions for Medical Device Inspection Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监科[2015]249号 Supervision & Inspection,Product Type Testing 2015-11-04 2015-11-04
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
Notice of the State Administration for Food and Drug Administration on Issuing the Guiding Principles for On site Inspection of Medical Device Operation Quality Management Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监械监[2015]239号 Supervision & Inspection,Distribution 2015-10-15 2015-10-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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