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Latest Regulations
1153 Results
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Notice on Public Solicitation of Opinions on the Guiding Principles for Review of Changes in Registration of In Vitro Diagnostic Reagents (Draft for Solicitation of Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230531
Registration & Filing
2023-05-31
2023-05-30
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for registration and review of recombinant collagen wound dressings
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第16号-f1
Registration & Filing
2023-05-23
2023-05-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Evaluation of Recombinant Humanized Collagen Raw Materials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第16号-f2
Registration & Filing
2023-05-23
2023-05-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Hemodialysis Concentrates (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第15号-f1
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 Technical Review of Blood Dialyzer Registration (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第15号-f2
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 and Review of Disposable Blood Separation Devices (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第15号-f3
Registration & Filing
2023-04-28
2023-04-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
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
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