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Latest Regulations
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Announcement of the National Medical Products Administration on Adjusting Part of the Content of the Classification Catalogue of Medical Devices (No. 25, 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第25号
Pre-Market
2022-03-24
2022-03-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the National Medical Products Administration on the Implementation of the Catalogue of Class I Medical Device Products (No. 107 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第107号
Pre-Market
2021-12-31
2021-12-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Revision Explanation of the Catalogue of Class I Medical Device Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20211231-2
Pre-Market
2021-12-31
2021-12-31
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Medical Device
Announcement of the National Medical Products Administration on Issuing the Catalogue of Class I Medical Device Products (No. 158 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第158号
Pre-Market
2021-12-31
2022-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Announcement of the National Medical Products Administration on Issuing the Classification Rules for In Vitro Diagnostic Reagents (No. 129 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第129号
Pre-Market
2021-10-29
2021-10-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Interpretation of the Classification Rules for In Vitro Diagnostic Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20211029
Pre-Market
2021-10-29
2021-10-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Notice on Soliciting Opinions on the Guiding Principles for Classification and Definition of Blood Component Separation and Packaging Equipment (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210830
Pre-Market
2021-08-30
2021-08-30
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Guidelines
Medical Device
Notice on soliciting opinions on the definition of attributes of medical radiation protection sprays (draft for soliciting opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NIFDC-20210812
Pre-Market
2021-08-12
2021-08-12
Status
Issued By
Level of Legal Effect
Product Category
Draft
Center for …
Work Documents
Medical Device
Notice on Matters Related to Registration of Pharmaceutical Device Combination Products (No. 52 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第52号
Pre-Market
2021-07-27
2021-07-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Combination Product
Interpretation of Notice on Matters Related to Registration of Pharmaceutical Device Combination Products (No. 52, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210727-2
Pre-Market
2021-07-27
2021-07-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Combination Product
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