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Latest Regulations
1153 Results
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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
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
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