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Latest Regulations

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Notice of the National Medical Products Administration's Equipment Review Center on Issuing the Guidelines for Registration and Review of Monkeypox Virus Nucleic Acid Testing Reagents (No. 10 of 2024)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第10号 Registration & Filing 2024-03-18 2024-03-15
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … UNKNOWN UNKNOWN
None
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第12号-f1 Registration & Filing 2024-03-18 2024-03-15
Status Issued By Level of Legal Effect Product Category Valid UNKNOWN UNKNOWN UNKNOWN
None
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第12号-f2 Registration & Filing 2024-03-18 2024-03-15
Status Issued By Level of Legal Effect Product Category Valid UNKNOWN UNKNOWN UNKNOWN
Guidelines for Registration and Review of Abdominal Endoscopic Surgical Systems Part 3: Three Dimensional Endoscopy
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第12号-3 Registration & Filing 2024-03-18 2024-03-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … UNKNOWN UNKNOWN
Guiding Principles for Registration and Review of Medical Device Optical Radiation Safety
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2024年第12号-4 Registration & Filing 2024-03-18 2024-03-15
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 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
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