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Latest Regulations
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Notice of the National Medical Products Administration on Issuing 13 Guiding Principles for Registration Technical Review of Root Point Localizers and Other Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第79号-f12
Registration & Filing
2019-11-15
2019-11-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of 13 Registration Technologies, including Urodynamic Analyzers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第79号-f13
Registration & Filing
2019-11-15
2019-11-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Registration of Instructions for Household Medical Devices (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20191105
Registration & Filing
2019-11-05
2019-11-05
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of 3D Printing Spinal Fusion Device Product Registration (Solicitation of Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20191104-1
Registration & Filing
2019-11-04
2019-11-04
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Hemodialysis Equipment Registration (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20191104-2
Registration & Filing
2019-11-04
2019-11-04
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing Guiding Principles for the Review of Three Registration Technologies, including Embryo Transfer Catheters for Assisted Reproduction
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第78号-f1
Registration & Filing
2019-11-01
2019-10-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing Three Guiding Principles for Registration Technical Review, including Verification and Confirmation of Testing Methods for Known Leachable Substances in Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第78号-f2
Registration & Filing
2019-11-01
2019-10-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Extracorporeal Circulation Pipelines for Cardiopulmonary Bypass Systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第78号-f3
Registration & Filing
2019-11-01
2019-10-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Aspartate Aminotransferase Assay Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第74号-f1
Registration & Filing
2019-10-29
2019-10-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for the Review of Four Registration Technologies, including Total Cholesterol Determination Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第74号-f2
Registration & Filing
2019-10-29
2019-10-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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