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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 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
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
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
Explanation of "Typical Application Lenses" in Article 4.2.4.3 of GB11417.3-2012 Ophthalmic Optics - Part 3: Soft Contact Lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 光秘函字[2017]2号 Product Type Testing 2019-08-12 2017-02-15
Status Issued By Level of Legal Effect Product Category Valid Zhejiang Medical … Normative Documents Medical Device
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