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Notice of the National Medical Products Administration on Issuing the Operating Norms for Registration and Approval of Domestic Class III and Imported Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2021〕53号 Registration & Filing 2021-11-04 2021-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Notice of the National Medical Products Administration on Issuing the Operating Norms for Registration and Approval of Class II Medical Devices in China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2021〕54号 Registration & Filing 2021-11-04 2021-11-02
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement of the National Medical Products Administration on Issuing the Classification Rules for In Vitro Diagnostic Reagents (No. 129 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第129号 Pre-Market 2021-10-29 2021-10-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of the Classification Rules for In Vitro Diagnostic Reagents
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211029 Pre-Market 2021-10-29 2021-10-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Notice on Matters Related to Technical Review during the Transition Period of the Implementation of New Regulations (No. 14, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第14号 Registration & Filing 2021-10-28 2021-10-28
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Interpretation of the Regulations on Self inspection Management of Medical Device Registration
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211027 Product Type Testing 2021-10-27 2021-10-27
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Announcement of the National Medical Products Administration on Issuing the Regulations on Self inspection Management of Medical Device Registration (No. 126 of 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第126号 Product Type Testing 2021-10-22 2021-10-21
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Guiding Principles for Registration and Review of Traditional Chinese Medicine Moxibustion Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20211022-3-f29 Registration & Filing 2021-10-22 2021-10-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for bacterial endotoxin limits and detection of disposable intraocular ophthalmic instruments (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20211022-3-f22 Registration & Filing 2021-10-22 2021-10-22
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Announcement No. 121 of 2021 on the Requirements for Publishing Registration and Application Materials for Medical Devices and the Format of Approval Documents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第121号 Registration & Filing 2021-09-30 2022-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
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