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Latest Regulations
1153 Results
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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 Public Solicitation of Key Points for Animal Trial Evaluation of Extracorporeal Membrane Oxygenation (ECMO) Consumable Products (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230710
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Review Key Points
Medical Device
Notice on Issuing Guiding Principles for Clinical Evaluation, Registration and Review of the Same Variety of Respirators by the Equipment Review Center of the National Medical Products Administration (No. 21, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第21号
Registration & Filing
2023-07-10
2023-07-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Key points for technical evaluation of imaging ultrasound artificial intelligence software (process optimization functions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f1
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Key points for performance evaluation and evaluation of artificial intelligence analysis software for pathological images
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f2
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Key points for clinical evaluation and evaluation of artificial intelligence analysis software for pathological images
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f3
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Key points for performance evaluation and evaluation of flow cytometry artificial intelligence analysis software for blood diseases
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第23号-f4
Registration & Filing
2023-07-10
2023-07-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
Guiding Principles for Registration and Review of Blood Melting Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f1
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding principles for registration and review of medical respiratory humidifiers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f2
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
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