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Latest Regulations
995 Results
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Notice of the National Medical Products Administration on Issuing Six Guiding Principles for Personalized Matching of Bone Implants and Tools, including Medical and Industrial Mutual Quality Control
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第62号-f6
Registration & Filing
2020-09-24
2020-09-17
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 Cryptococcal Antigen Detection Reagent Registration (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200821-3
Registration & Filing
2020-08-21
2020-08-21
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Registration of Nitrous Acid Inhalation Sedative and Analgesic Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第49号
Registration & Filing
2020-07-20
2020-07-15
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 Six Guiding Principles for Registration Technology Review of Disposable Breast Positioning Silk
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第48号-f1
Registration & Filing
2020-07-09
2020-07-07
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 Six Guiding Principles for Registration Technology Review of Dural (Spinal) Membrane Patches
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第48号-f2
Registration & Filing
2020-07-09
2020-07-07
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 Six Guiding Principles for Registration Technology Review, including the Registration Technology Review of Customized Personalized Bone Implants Equivalent Model
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第48号-f3
Registration & Filing
2020-07-09
2020-07-07
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 Six Guiding Principles for Registration Technical Review of Finite Element Analysis Data of Orthopedic Metal Implants
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第48号-f4
Registration & Filing
2020-07-09
2020-07-07
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 Six Registration Technical Review Guiding Principles, including Clinical Trial Guidelines for Hernia Repair Patches
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第48号-f5
Registration & Filing
2020-07-09
2020-07-07
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 Six Registration Technical Review Guidelines, including the Guidelines for Animal Experimental Research on Bioabsorbable Coronary Artery Drug eluting Stents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第48号-f6
Registration & Filing
2020-07-09
2020-07-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Combination Product
Notice on Public Solicitation of Opinions on the Guiding Principles for Technical Review of Changes in License Matters for In Vitro Diagnostic Reagents (Second Edition Draft for Solicitation of Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200701-2
Registration & Filing
2020-07-01
2020-07-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
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