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Latest Regulations
56 Results
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Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第27号
Clinical Evaluation
2024-09-27
2024-09-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
None
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240828
Product Type Testing,Manufacturing,Supervision & Inspection,Usage,Pre-Market,Clinical Evaluation,Distribution,Registration & Filing
2024-08-28
2024-08-26
Status
Issued By
Level of Legal Effect
Product Category
Draft
UNKNOWN
UNKNOWN
UNKNOWN
None
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2024年第22号
Clinical Evaluation
2024-06-14
2024-10-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
UNKNOWN
UNKNOWN
UNKNOWN
Notice of the National Medical Products Administration's Device Review Center on Issuing the Recommended Clinical Evaluation Pathways for Medical Device Classification Catalogue Related Products (2024 Supplement) (No. 11 of 2024)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第11号
Clinical Evaluation
2024-03-18
2024-03-15
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
UNKNOWN
UNKNOWN
Measures for Supervision and Inspection of Clinical Trial Institutions for Medical Devices (Trial) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240312-f1
Clinical Evaluation
2024-03-12
2024-03-08
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
UNKNOWN
UNKNOWN
Key points and determination principles for supervision and inspection of clinical trial institutions for medical devices (draft for second round solicitation of opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20240312-f2
Clinical Evaluation
2024-03-12
2024-03-08
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
UNKNOWN
UNKNOWN
Quality Technical Specifications for Clinical Trials of In Vitro Diagnostic Reagents (Draft for Comments) and Compilation Instructions
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230905-2
Clinical Evaluation
2023-09-05
2023-09-04
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Work Documents
IVD
Draft Quality Technical Specifications for Clinical Trials of Medical Devices (for Comments) and Compilation Instructions
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230905-1
Clinical Evaluation
2023-09-05
2023-09-04
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Work Documents
Medical Device
Notice on Updating the Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing Matters of Human Genetic Resources
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
MOST-20230714
Clinical Evaluation
2023-07-14
2023-07-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
Ministry of …
Work Documents
IVD
Announcement on Adjusting the Management of Human Genetic Resources
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
MOST-20230627
Clinical Evaluation
2023-06-27
2023-06-21
Status
Issued By
Level of Legal Effect
Product Category
Valid
Ministry of …
Announcements
IVD
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