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Latest Regulations
995 Results
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ASC
DESC
Notice on Issuing Guiding Principles for Clinical Evaluation, Registration and Review of Medical X-ray Diagnostic Equipment (Class III) of the Same Variety by the Equipment Review Center of the National Medical Products Administration (No. 30, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第30号
Registration & Filing
2023-08-04
2023-08-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Clinical Evaluation and Registration Review of the Same Product of Positron Emission/X-ray Computed Tomography Systems (No. 31, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第31号
Registration & Filing
2023-08-04
2023-08-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Medical Dressing Products (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20230804
Registration & Filing
2023-08-04
2023-08-04
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Disposable Membrane Oxygenator (CPB) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230802-1
Registration & Filing
2023-08-02
2023-08-02
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Dialysate Filters (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230802-2
Registration & Filing
2023-08-02
2023-08-02
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 Clinical Evaluation, Registration and Review of Laser Therapy Equipment of the Same Variety (No. 28, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第28号
Registration & Filing
2023-07-31
2023-07-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Clinical Evaluation, Registration and Review of Hip Joint Prostheses of the Same Variety (No. 27, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第27号
Registration & Filing
2023-07-24
2023-07-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of extracorporeal membrane oxygenation (ECMO) temperature control equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第26号-f1
Registration & Filing
2023-07-20
2023-07-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding principles for registration and review of mobile electrocardiogram and atrial fibrillation detection products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第26号-f2
Registration & Filing
2023-07-20
2023-07-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for insulin pump registration review
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第26号-f3
Registration & Filing
2023-07-20
2023-07-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
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