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Latest Regulations

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Notice on Public Solicitation of Comments on the Draft Results Document of the Continued Project "Postmarket Clinical Follow up Study" by the IMDRF Medical Device Clinical Evaluation Working Group
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20201021-2 Clinical Evaluation 2020-10-21 2020-10-21
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Work Documents Medical Device
Notice of the Office of Human Genetic Resources Management of China on Further Optimizing the Administrative Approval Process for Human Genetic Resources
Regulation No. Product LifeCycle Issued Date Implemented Date MOST-20201021 Clinical Evaluation 2020-10-21 2020-10-19
Status Issued By Level of Legal Effect Product Category Valid Ministry of … Work Documents IVD
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Catalogue of 6840 in Vitro Diagnostic Reagents (2013 Edition)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第112号 Pre-Market 2020-10-20 2020-10-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Catalogue of 6840 in Vitro Diagnostic Reagents (2013 Edition)
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第112号 Pre-Market 2020-10-20 2020-10-10
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … 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
Summary of Classification and Definition Results for the Second Batch of Medical Device Products in 2020
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20200930-2 Pre-Market 2020-09-30 2020-09-30
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents Combination Product
Summary of Classification and Definition Results for the Second Batch of Medical Device Products in 2020
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20200930-2 Pre-Market 2020-09-30 2020-09-30
Status Issued By Level of Legal Effect Product Category Valid National Health … Work Documents Combination Product
Announcement of the National Medical Products Administration, the National Health Commission, and the National Medical Insurance Administration on Deepening the Pilot Program and Doing a Good Job in the First Batch of Implementing Unique Identification of Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第106号 Pre-Market 2020-09-30 2020-09-29
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Notice on the Trial Implementation of Electronic Signature for Registration and Application Materials of Imported Medical Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20200929-3 Registration & Filing 2020-09-29 2020-09-29
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Work Documents IVD
Announcement of the National Medical Products Administration on Matters Related to the Production of Imported Medical Device Products by Enterprises within China
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2020年第104号 Registration & Filing 2020-09-25 2020-09-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
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