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Latest Regulations
1882 Results
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Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Work Rules of the Medical Device Classification Technical Committee of the National Medical Products Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注〔2023〕23号
Pre-Market
2023-03-14
2023-03-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
The Comprehensive Department of the National Medical Products Administration publicly solicits opinions on the "Classification Catalogue of In Vitro Diagnostic Reagents (Revised Draft for Comments)"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20230314
Pre-Market
2023-03-14
2023-03-08
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
Guiding Principles for Registration Review of Dental Adhesive Products (No. 3 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第3号-f1
Registration & Filing
2023-03-09
2023-03-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Artificial Shoulder Joint Prostheses (No. 3 of 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第3号-f2
Registration & Filing
2023-03-09
2023-03-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration and Examination of novel coronavirus (2019 nCoV) Nucleic Acid Detection Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第2号-f1
Registration & Filing
2023-03-02
2023-03-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Examination of novel coronavirus (2019 nCoV) Antibody Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第2号-f2
Registration & Filing
2023-03-02
2023-03-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Examination of novel coronavirus (2019 nCoV) Antigen Detection Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第2号-f3
Registration & Filing
2023-03-02
2023-03-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Notice on Supplementary Explanation on the Implementation of the Ten Related Matters of the Market Supervision Administration, the State Food and Drug Administration, the China National Intellectual Property Administration Supporting the Resumption of Work and Production
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230220
Registration & Filing
2023-02-20
2023-02-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Announcement of the National Medical Products Administration, the National Health Commission, and the National Medical Insurance Administration on Doing a Good Job in the Third Batch of Implementing Unique Identification of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2023年第22号
Pre-Market
2023-02-17
2023-02-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Interpretation of the Naming Guidelines for Recombinant Collagen Biomaterials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20230129
Pre-Market
2023-01-29
2023-01-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Medical Device
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