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Latest Regulations

1153  Results

Interpretation of the Guiding Principles for Registration and Review of Medical Device Animal Experiment Research
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20211122-1 Registration & Filing 2021-11-22 2021-11-22
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents Medical Device
Notice on Issuing the Folder Structure of the Electronic Declaration Catalog for Medical Device Registration (No. 15, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第15号 Registration & Filing 2021-11-15 2022-01-01
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements Medical Device
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 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
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
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
Announcement No. 122 of 2021 on the Requirements for Publishing Registration and Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第122号 Registration & Filing 2021-09-30 2022-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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