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Latest Regulations
995 Results
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Guidelines for the Review of Respirator Registration (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第8号-f3
Registration & Filing
2024-02-06
2024-02-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
UNKNOWN
UNKNOWN
Guiding Principles for Registration Review of Nitric Oxide Therapy Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第8号-f4
Registration & Filing
2024-02-06
2024-02-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
UNKNOWN
UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Evaluation, Registration and Review of In Vitro Diagnostic Reagents for Colorectal Cancer Screening (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20240206
Registration & Filing
2024-02-06
2024-02-06
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
UNKNOWN
UNKNOWN
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Registration of Ophthalmic Phacoemulsification and Vitrectomy Equipment and Accessories (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20240123
Registration & Filing
2024-01-23
2024-01-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Clinical Evaluation, Registration and Review of In Vitro Diagnostic Reagents for Tumor Screening (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20240122-f1
Registration & Filing
2024-01-22
2024-01-19
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration Review of PD-L1 Antibody Reagents and Detection Kits (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20240122-f2
Registration & Filing
2024-01-22
2024-01-19
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Monkeypox Virus Nucleic Acid Testing Reagents (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20240118
Registration & Filing
2024-01-18
2024-01-18
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Remote Monitoring Systems (No. 5, 2024)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第5号
Registration & Filing
2024-01-18
2024-01-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Clinical Trial Registration Review of Non Small Cell Lung Cancer Related Gene Variation Detection Reagents Based on High throughput Sequencing Technology
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第4号-f1
Registration & Filing
2024-01-18
2024-01-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Clinical Trial Registration Review of Immunodeficiency Virus like Testing Reagents (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第4号-f2
Registration & Filing
2024-01-18
2024-01-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
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