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Latest Regulations
1789 Results
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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
Notice on Updating the Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing Matters of Human Genetic Resources
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
MOST-20230714
Clinical Evaluation
2023-07-14
2023-07-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
Ministry of …
Work Documents
IVD
Summary of the results of the second classification and definition of medical device products in 2023
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20230713
Pre-Market
2023-07-13
2023-07-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Non-Medical Device
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