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Latest Regulations
1153 Results
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Title
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Guidelines for Registration Review of Disposable Hydrocephalus Diverters (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-1
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Absorbable Surgical Sutures (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-2
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Disposable Intravenous Indwelling Needles (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-3
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration and Review of Disposable Hemodialysis Tubing (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-4
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Review of Hydrogel Dressing Registration (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231115-5
Registration & Filing
2023-11-15
2023-11-15
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Classification and Definition of Medical Devices for Myopia Control and Amblyopia Treatment (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231113
Registration & Filing
2023-11-13
2023-11-13
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Notice on Issuing the Guiding Principles for Clinical Evaluation and Registration Review of Medical Devices (Software) Assisted by Artificial Intelligence by the Equipment Review Center of the National Medical Products Administration (No. 38 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-2023年第38号
Registration & Filing
2023-11-07
2023-11-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Intraperitoneal Endoscopic Surgery Systems Part 3: Three Dimensional Endoscopy (Draft for Solicitation of Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231107-1
Registration & Filing
2023-11-07
2023-11-07
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Reprocessing Instructions and Confirmation Methods for Reusable Medical Devices (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231107-2
Registration & Filing
2023-11-07
2023-11-07
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration Review of Positron Emission Magnetic Resonance Imaging Systems (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231102-1
Registration & Filing
2023-11-02
2023-11-02
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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