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Latest Regulations
995 Results
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Notice of the State Administration on Issuing the Guiding Principles for the Review of Three Registration Technologies, including Apolipoprotein B Assay Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2018年第9号-f2
Registration & Filing
2018-01-16
2018-01-08
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the State Administration on Issuing Three Technical Review Guiding Principles for Disposable Infusion Pumps (Non Electric Drive) and Other Technologies
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2018年第3号-f2
Registration & Filing
2018-01-10
2018-01-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing Three Technical Review Guidelines for Blood Concentrators and Other Technologies
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2018年第3号-f3
Registration & Filing
2018-01-10
2018-01-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing Three Technical Review Guiding Principles for Whole Blood and Blood Component Storage Bags
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2018年第3号-f1
Registration & Filing
2018-01-10
2018-01-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Medical Devices of Animal Origin (Revised in 2017)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第224号
Registration & Filing
2018-01-05
2017-12-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Mobile Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第222号
Registration & Filing
2017-12-29
2017-12-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Electrolyte Potassium, Sodium, Chlorine, and Calcium Determination Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第213号-f3
Registration & Filing
2017-12-22
2017-12-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Interpretation of Issues Related to the Guiding Principles for Research and Evaluation of Cell Therapy Products (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20171222
Registration & Filing
2017-12-22
2017-12-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including High Density Lipoprotein Cholesterol Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第213号-f4
Registration & Filing
2017-12-22
2017-12-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Cystatin C Determination Reagents (Latex Transmission Immunoturbidimetry)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第213号-f5
Registration & Filing
2017-12-22
2017-12-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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