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Latest Regulations
1789 Results
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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
Summary of the results of the third classification and definition of medical device products in 2023
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20231103
Pre-Market
2023-11-03
2023-11-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Non-Medical Device
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
Guidelines for Registration Review of Single Photon Emission and X-ray Computed Tomography Systems (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231102-2
Registration & Filing
2023-11-02
2023-11-02
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for the Review of Respirator Registration (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231102-3
Registration & Filing
2023-11-02
2023-11-02
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Nitric Oxide Therapy Devices (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231102-4
Registration & Filing
2023-11-02
2023-11-02
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Mobile Medical Devices (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231102-5
Registration & Filing
2023-11-02
2023-11-02
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Electric Photography Flat Bed (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-1
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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