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Latest Regulations

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Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the English Names of the First Batch of Key Laboratories
Regulation No. Product LifeCycle Issued Date Implemented Date 药监综科外函[2019]402号 Clinical Evaluation 2019-08-26 2019-08-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Normative Documents IVD
The Information Center of the National Medical Products Administration publicly solicits opinions on six information technology standards, including the "Basic Dataset for Medical Device Inspection (Draft for Comments)"
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190823-2 Supervision & Inspection 2019-08-23 2019-08-23
Status Issued By Level of Legal Effect Product Category Draft NMPA/National Medical … Work Documents IVD
Explanation on Relevant Issues Concerning the Delivery of Proof Documents for the Approval Results of Administrative Licensing Matters
Regulation No. Product LifeCycle Issued Date Implemented Date NMPA-20190820-1 Registration & Filing 2019-08-20 2019-08-20
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents 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
Explanation on the expression of "new materials" and their applicable tests in the GB11417 series of national standards for ophthalmic optical contact lenses
Regulation No. Product LifeCycle Issued Date Implemented Date 光秘函字[2017]3号 Product Type Testing 2019-08-12 2017-02-14
Status Issued By Level of Legal Effect Product Category Valid Zhejiang Medical … Normative Documents Medical Device
Notice on Cleaning up Copy of Paper Application Materials for Completed Medical Device Product Registration Projects
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2019年第8号 Registration & Filing 2019-08-08 2019-08-08
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Announcement on Adjusting the Consultation Service Arrangement of the Administrative Acceptance Service Hall of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第245号 Registration & Filing 2019-08-01 2019-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements 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 of the Comprehensive Department of the National Medical Products Administration on the Release of 24 Medical Device Industry Standards, including YY/T0506.8-2019 "Surgical Orders, Surgical gowns, and Cleanwear for Patients, Medical Personnel, and Devices Part 8: Product Specific Requirements"
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第60号 Product Type Testing 2019-07-30 2020-08-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement on the Results of Defining the Attributes of the Thirteenth Batch of Pharmaceutical Device Combination Products
Regulation No. Product LifeCycle Issued Date Implemented Date 国药监局公告2019年第244号 Pre-Market 2019-07-18 2019-07-18
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Combination Product
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