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Latest Regulations

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Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Evaluation, Registration and Review of the Same Variety of Radiofrequency Microwave Ablation Equipment (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240218 Registration & Filing 2024-02-18 2024-02-08
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Estrogen Receptor and Progesterone Receptor Antibody Reagents and Detection Kits (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240207 Registration & Filing 2024-02-07 2024-02-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … UNKNOWN UNKNOWN
Notice on Key Points for Technical Evaluation of Laser Equipment for Myopia and Amblyopia issued by the Equipment Review Center of the National Medical Products Administration (No. 6, 2024)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第6号 Registration & Filing 2024-02-06 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Guidelines for registration review of positron emission magnetic resonance imaging systems
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第8号-f1 Registration & Filing 2024-02-06 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Guidelines for registration and review of single photon emission X-ray computed tomography systems
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第8号-f2 Registration & Filing 2024-02-06 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Guidelines for the Review of Respirator Registration (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第8号-f3 Registration & Filing 2024-02-06 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Guiding Principles for Registration Review of Nitric Oxide Therapy Devices
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第8号-f4 Registration & Filing 2024-02-06 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Evaluation, Registration and Review of In Vitro Diagnostic Reagents for Colorectal Cancer Screening (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240206 Registration & Filing 2024-02-06 2024-02-06
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … UNKNOWN UNKNOWN
Notice on Adjusting the Business Scope of the Electronic Declaration Information System for Medical Device Registration (No. 7, 2024)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第7号 Registration & Filing 2024-02-05 2024-02-05
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Registration of Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories (Revised in 2023)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20240123 Registration & Filing 2024-01-23 2024-01-23
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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