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Latest Regulations
1220 Results
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Guidelines for registration review of positron emission/X-ray computed tomography systems (digital technology specific)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第108号-f2
Registration & Filing
2022-01-19
2020-12-31
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding Principles for Registration Review of Pharmaceutical Device Combination Products with Medical Device Functions as the Main Function
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第3号-f1
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Combination Product
Guiding Principles for Registration and Review of Qualitative, Quantitative, and In Vitro Release Studies of Drugs in Pharmaceutical Device Combination Products with Medical Device Functions as the Main Function
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第3号-f2
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Combination Product
Guidelines for registration and review of disposable endoscopic injection needles
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第4号-f5
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding principles for registration and review of artificial intraocular lenses
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第4号-f6
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guidelines for registration and review of biodegradable magnesium metal orthopedic implants
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第4号-f3
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding principles for the registration and review of microcatheters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第4号-f4
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding Principles for Registration Review of Disposable High Pressure Imaging Syringes and Accessories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第4号-f1
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding Principles for Registration Review of Metal Orthopedic Plate Internal Fixation System Products (Revised in 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第4号-f2
Registration & Filing
2022-01-17
2022-01-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Publicly Soliciting Opinions on the Guiding Principles for Registration and Review of CT Imaging Assisted Detection Software for Pulmonary Nodules
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220112
Registration & Filing
2022-01-12
2022-01-10
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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