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Latest Regulations
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Guiding principles for safety and efficacy evaluation of medical devices using nanomaterials Part 2: Physical and chemical characterization
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第15号-f6
Registration & Filing
2023-04-28
2023-04-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Disposable Infusion Devices (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第15号-f4
Registration & Filing
2023-04-28
2023-04-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Disposable Light Avoidant Infusion Set (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第15号-f5
Registration & Filing
2023-04-28
2023-04-26
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 Registration and Review of Intense Pulse Phototherapy Equipment (Revised in 2023) (No. 12 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第12号
Registration & Filing
2023-04-28
2023-04-20
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 and Review of Ophthalmic Optical Measurement Equipment (No. 13, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第13号
Registration & Filing
2023-04-28
2023-04-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Tracheal Intubation Products (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f1
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Disposable Surgical gowns (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f2
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Natural Latex Rubber Condom Products (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f3
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Disposable Vacuum Blood Collection Products (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f4
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Alloy Products Used in Denture Manufacturing (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f5
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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