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Latest Regulations
995 Results
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Title
ASC
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Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Non invasive Blood Glucose Monitoring Products (No. 42 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第42号
Registration & Filing
2023-12-25
2023-12-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Energy Spectrum Imaging Technology for X-ray Computed Tomography Equipment (Draft for Solicitation of Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231225-3
Registration & Filing
2023-12-25
2023-12-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Clinical Trial Registration and Review of Intracranial Thrombolytic Stents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231211-1
Registration & Filing
2023-12-11
2023-12-11
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of Extracorporeal Membrane Pulmonary Oxygenation Systems (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231211-2
Registration & Filing
2023-12-11
2023-12-11
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of the Same Variety of Spring Coil Systems (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231211-3
Registration & Filing
2023-12-11
2023-12-11
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Clinical Trial Registration and Review of Facial Injection Filler Materials (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231211-4
Registration & Filing
2023-12-11
2023-12-11
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 High Frequency Surgical Instruments for Soft Endoscopes (Draft for Solicitation of Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231206
Registration & Filing
2023-12-06
2023-12-05
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Extracorporeal Membrane Oxygen (ECMO) Loop Animal Trials (No. 39 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第39号
Registration & Filing
2023-12-06
2023-12-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Clinical Evaluation, Registration and Review of Individualized Drug Genetic Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231206-1
Registration & Filing
2023-12-06
2023-12-06
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of HLA-B27 Genetic Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231206-2
Registration & Filing
2023-12-06
2023-12-06
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
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