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Latest Regulations
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Guiding Principles for Registration Review of Liquid Dressing Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f9
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 gel dressing product registration review
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f10
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
β- Guiding Principles for Registration Review of Hydroxybutyric Acid Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f11
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for registration and review of methotrexate testing reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f12
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding principles for registration and review of anti cyclic citrullinated peptide antibody detection reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f13
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Gram Positive Bacterial Identification Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第22号-f14
Registration & Filing
2023-07-07
2023-07-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Notice on Issuing the Guiding Principles for Clinical Evaluation, Registration and Review of Same Variety of Intervertebral Fusion Cages by the Equipment Review Center of the National Medical Products Administration (No. 20, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第20号
Registration & Filing
2023-06-28
2023-06-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Clinical Evaluation, Registration and Review of Absorbable Surgical Sutures of the Same Variety (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230625-f1
Registration & Filing
2023-06-25
2023-06-21
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Clinical Evaluation, Registration and Review of Disposable Blood Dialyzers (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230625-f3
Registration & Filing
2023-06-25
2023-06-21
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 Key Points for Technical Evaluation of Abdominal Endoscopic Surgery Systems (Revised in 2023) (No. 18, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第18号
Registration & Filing
2023-06-19
2023-06-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
Medical Device
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