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Latest Regulations
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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
Guiding principles for registration and review of intestinal hydrotherapy machines
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f3
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 review of medical molecular sieve oxygen concentrators
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f4
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of bladder ultrasound scanners
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f5
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of disposable peritoneal dialysis catheters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f6
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of respiratory system filters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f7
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 Review of Oral/Nasopharyngeal Airways
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f8
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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