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Latest Regulations

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Reply from the General Office of the State Administration for Food and Drug Administration on Issues Related to Individual Businesses Engaging in Medical Device Business Activities
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]533号 Distribution 2015-09-02 2015-09-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Opinions of the State Council on Reforming the Drug and Medical Device Evaluation and Approval System
Regulation No. Product LifeCycle Issued Date Implemented Date 国发[2015]44号 Registration & Filing 2015-08-18 2015-08-18
Status Issued By Level of Legal Effect Product Category Valid State Council … UNKNOWN UNKNOWN
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of Medical Device Software Registration
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第50号 Registration & Filing 2015-08-05 2015-08-05
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Administration for Food and Drug Administration on Further Strengthening the Review and Supervision of Advertisements for Drugs, Medical Devices, and Health Food
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监稽[2015]145号 Supervision & Inspection,Distribution 2015-07-31 2015-07-31
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 the Classification and Definition of 127 Products, including Multi functional Ultrasound Bone Knife
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械管[2015]104号 Pre-Market 2015-07-20 2015-07-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Interpretation of Medical Device Registration Management Regulations III (Explanation on the Revision of the Classification Rules for Medical Devices)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20150716 Pre-Market 2015-07-16 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Combination Product
Notice of the State Food and Drug Administration on Issuing the Technical Review Guidelines for Hepatitis B Virus Genotyping Testing Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第32号 Registration & Filing 2015-07-15 2015-07-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines IVD
Notice of the State Food and Drug Administration on Issuing the Guiding Principles for Technical Review of New Technology Registration of Imaging Ultrasound Diagnostic Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第33号 Registration & Filing 2015-07-15 2015-07-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Guidelines Medical Device
Notice of the State Food and Drug Administration on Implementing the Policy of Preferential Administrative Fees for Small and Micro Enterprises
Regulation No. Product LifeCycle Issued Date Implemented Date 总局通告2015年第31号 Registration & Filing 2015-07-14 2015-07-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Reply from the General Office of the State Administration for Food and Drug Administration on Relevant Issues Concerning the Operation of Ear Back Digital Hearing Aids with Exemption from Inspection
Regulation No. Product LifeCycle Issued Date Implemented Date 食药监办械监函[2015]414号 Distribution 2015-07-14 2015-07-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
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