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Latest Regulations

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Announcement of the National Medical Products Administration on the Release of 41 Medical Device Industry Standards and 2 Amendment Orders, including YY0485-2020 "Disposable Cardiac Arrest Infusion Device"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年76号 Product Type Testing 2020-07-09 2020-06-30
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Issuing 12 Medical Device Industry Standards and 1 Amendment Order, including YY0336-2020 "Disposable Sterile Vaginal Dilator"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第48号 Product Type Testing 2020-04-09 2020-03-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Forwarding Explanation on "Special Design Sutures" in the Applicable Scope of Industry Standards YY1116-2020 and YY0167-2020
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20200310 Product Type Testing 2020-03-10 2020-03-06
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents Medical Device
Announcement of the National Medical Products Administration on Issuing 24 Medical Device Industry Standards and 6 Revision Orders, including YY0833-2020 General Technical Requirements for Limb Pressure Therapy Equipment
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第20号 Product Type Testing 2020-03-06 2020-02-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on the Release of 7 Medical Device Industry Standards and 1 Amendment Order, including YY0167-2020 Non Absorbable Surgical Sutures
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第21号 Product Type Testing 2020-03-02 2020-02-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Issuing Six Industry Standards, including "Medical Diagnostic X-ray Radiation Protection Equipment Part 1: Determination of Material Attenuation Performance"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第18号 Product Type Testing 2020-03-02 2020-02-25
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Management Measures for Compulsory National Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 总局令2020年第25号 Product Type Testing 2020-01-06 2020-06-01
Status Issued By Level of Legal Effect Product Category Valid SAMR/State Administration … Departmental Rules IVD
Announcement of the National Medical Products Administration on the Conversion of 40 Mandatory Medical Device Industry Standards, including "Medical Diagnostic X-ray Radiation Protection Equipment Part 1: Determination of Material Attenuation Performance", into Recommended Industry Standards
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第106号 Product Type Testing 2019-12-17 2019-12-09
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on the Release of 21 Medical Device Industry Standards and 1 Amendment Order, including YY/T 0464-2019 "Disposable Hemoperfusion Devices"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第84号 Product Type Testing 2019-11-13 2019-10-23
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Capacity Building of Medical Device Inspection and Testing Institutions
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监科外[2019]36号 Supervision & Inspection,Product Type Testing 2019-08-30 2019-08-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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