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Latest Regulations
1882 Results
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Announcement of the National Medical Products Administration on Matters Related to the Filing of Class I Medical Devices (No. 62 of 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2022年第62号
Registration & Filing
2022-08-11
2022-08-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Revision Explanation of the Announcement on Matters Related to the Filing of Class I Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20220811
Registration & Filing
2022-08-11
2022-08-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Notice on Activating the Second Page of the New Inspection Report of the China Inspection and Quarantine Institute
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20220727
Product Type Testing
2022-07-27
2022-07-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
National Health …
Work Documents
IVD
Notice on the Key Points for Technical Evaluation of Monkeypox Virus Nucleic Acid Testing Reagents (Trial) issued by the Equipment Review Center of the National Medical Products Administration (No. 31, 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第31号
Registration & Filing
2022-07-15
2022-07-15
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
IVD
Notice on the Release of Clinical Evaluation Recommended Pathways for Related Products in Subcategories 01, 04, 07, 08, 09, 10, 19, and 21 of the Classification Catalogue of Medical Devices (No. 30, 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第30号
Clinical Evaluation
2022-07-14
2022-07-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
Medical Device
Summary of Classification and Definition Results for Medical Devices in 2022
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20220713
Pre-Market
2022-07-13
2022-07-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Non-Medical Device
Notice on Issuing Technical Guidelines for Compliance with Basic Principles of Safety and Performance of Medical Devices by the Equipment Review Center of the National Medical Products Administration (No. 29, 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第29号
Registration & Filing
2022-07-13
2022-07-12
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Announcement on the Migration and Renaming of the Human Genetic Resources Information Backup Platform
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
MOST-20220711
Clinical Evaluation
2022-07-11
2022-07-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
Ministry of …
Announcements
IVD
Summary of Attribute Definition Results for Pharmaceutical Device Combination Products from 2021 to 2022
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20220707
Pre-Market
2022-07-07
2022-07-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
Center for …
Work Documents
Combination Product
Notice on Publicly Soliciting Opinions on the Catalogue of Medical Devices Exempted from Clinical Evaluation and the Catalogue of In Vitro Diagnostic Reagents Exempted from Clinical Trials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220705
Clinical Evaluation
2022-07-05
2022-07-05
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Work Documents
IVD
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