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Latest Regulations
1789 Results
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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 Matters Related to Technical Review during the Transition Period of the Implementation of New Regulations (No. 14, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第14号
Registration & Filing
2021-10-28
2021-10-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Interpretation of the Regulations on Self inspection Management of Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20211027
Product Type Testing
2021-10-27
2021-10-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration on Issuing the Regulations on Self inspection Management of Medical Device Registration (No. 126 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第126号
Product Type Testing
2021-10-22
2021-10-21
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Guiding Principles for Registration and Review of Traditional Chinese Medicine Moxibustion Equipment (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20211022-3-f29
Registration & Filing
2021-10-22
2021-10-22
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for bacterial endotoxin limits and detection of disposable intraocular ophthalmic instruments (draft for soliciting opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20211022-3-f22
Registration & Filing
2021-10-22
2021-10-22
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Announcement No. 121 of 2021 on the Requirements for Publishing Registration and Application Materials for Medical Devices and the Format of Approval Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第121号
Registration & Filing
2021-09-30
2022-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Announcement No. 122 of 2021 on the Requirements for Publishing Registration and Application Materials of In Vitro Diagnostic Reagents and the Format of Approval Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第122号
Registration & Filing
2021-09-30
2022-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice of the National Medical Products Administration on the Implementation of the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (No. 76 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第76号
Registration & Filing
2021-09-29
2021-09-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Technical Guidelines for Clinical Evaluation of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第73号-f1
Clinical Evaluation
2021-09-28
2021-09-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
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