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Latest Regulations

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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
Announcement of the National Medical Products Administration on Implementing the Regulations on the Supervision and Administration of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2021年第76号 Registration & Filing 2021-05-31 2021-05-31
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on Receiving Paper Materials for Self Withdrawal of Medical Device Registration Application Projects (No. 4, 2021)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2021年第4号 Registration & Filing 2021-03-17 2021-03-17
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Announcements IVD
Notice of the Comprehensive Department of the National Medical Products Administration on Relevant Matters Concerning the Implementation of the Minamata Convention on Mercury
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综械注[2020]95号 Registration & Filing 2020-10-16 2020-10-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents Medical Device
Notice on Matters Related to Changes in Registration Information of Registration Applicants
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200707-3 Registration & Filing 2020-07-07 2020-07-07
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice on the Exit Registration Procedure and Subsequent Handling Methods for Imported Medical Devices Applying for Product Registration in Class II and Confirmed as Class III through Technical Evaluation
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200605-2 Registration & Filing 2020-06-05 2020-06-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Notice of the National Medical Products Administration on Expanding the Pilot Work of the Medical Device Registration System
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监械注〔2019〕33号 Registration & Filing 2019-08-01 2019-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Announcement on Acceptance of Administrative Licensing Matters and Submission of Authorization Letter for Approval Collection
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第232号 Registration & Filing 2019-02-25 2019-03-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Reply of the National Medical Products Administration on Agreeing to Carry out Pilot Work of the Medical Device Registration System
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监函[2018]43号 Registration & Filing 2018-08-16 2018-08-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
Reply of the National Medical Products Administration on Agreeing to Carry out Pilot Work of the Medical Device Registration System
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监函[2018]42号 Registration & Filing 2018-08-16 2018-08-14
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
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