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Latest Regulations

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Guiding Principles for Registration and Review of Absorbable Anti Adhesive Products for Abdominal and Pelvic Surgery (Revised in 2023) (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20231007-4 Registration & Filing 2023-10-07 2023-10-07
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Real World Research Design and Statistical Analysis of Medical Devices (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration Review of Corneal Topographer (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-1 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guiding Principles for Registration and Review of Intraperitoneal Endoscopic Surgery Systems Part 2: Animal Trial Decision Making and Requirements (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-2 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Guidelines for Registration and Review of High Frequency Surgical Equipment (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-3 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
Key points for technical evaluation of laser therapy equipment for myopia/amblyopia (draft for soliciting opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230928-5 Registration & Filing 2023-09-28 2023-09-28
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Review Key Points Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Medical Products in the Field of Organizational Engineering (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230915-1 Registration & Filing 2023-09-15 2023-09-15
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Nanomaterial Medical Products (Draft for Comments)
Regulation No. Product LifeCycle Issued Date Implemented Date NIFDC-20230915-2 Registration & Filing 2023-09-15 2023-09-15
Status Issued By Level of Legal Effect Product Category Draft Center for … Guidelines Medical Device
Notice on Key Points for Functional Evaluation of Artificial Intelligence Software in Magnetic Resonance Imaging Systems (No. 36 of 2023) issued by the Equipment Review Center of the National Medical Products Administration
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE通告2023年第36号 Registration & Filing 2023-09-15 2023-09-15
Status Issued By Level of Legal Effect Product Category Valid CMDE/Center for … Review Key Points Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Absorbable Internal Fixation Implants Part 1: Synthetic Polymer Materials (Draft for Solicitation of Opinions)
Regulation No. Product LifeCycle Issued Date Implemented Date CMDE-20230904 Registration & Filing 2023-09-04 2023-09-04
Status Issued By Level of Legal Effect Product Category Draft CMDE/Center for … Guidelines Medical Device
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