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Latest Regulations
1882 Results
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Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 33 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2023年第33号
Clinical Evaluation
2023-07-24
2023-07-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
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
Guiding Principles for Registration Review of High Flow Respiratory Therapy Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第26号-f4
Registration & Filing
2023-07-20
2023-07-19
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 Registration Review of Continuous Glucose Monitoring Systems (Revised in 2023) (No. 24 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第24号
Registration & Filing
2023-07-18
2023-07-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of transcatheter aortic valve systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第25号-f1
Registration & Filing
2023-07-18
2023-07-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Vascular Interventional Devices with Lubricating Coatings
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第25号-f2
Registration & Filing
2023-07-18
2023-07-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of non vascular self expanding metal stent systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第25号-f3
Registration & Filing
2023-07-18
2023-07-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Benefit Risk Assessment Technology of Medical Device Products (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第25号-f4
Registration & Filing
2023-07-18
2023-07-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
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