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Latest Regulations
1153 Results
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Title
ASC
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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
Notice of the State Administration on Issuing the Guiding Principles for the Review of Five Registration Technologies, including Cardiac Troponin I/Myoglobin/Creatine Kinase Isoenzyme MB Detection Reagents (Colloidal Gold Immunochromatography)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第213号-f2
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 Examination of Four Registration Technologies, including ABO and RhD Blood Group Antigen Detection Cards (Column Agglutination Method)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第209号-f2
Registration & Filing
2017-12-22
2017-12-14
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 5 Registration Technologies, including Luteinizing Hormone Testing Reagents (Colloidal Gold Immunochromatography)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第213号-f1
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 Four Registration Technologies, including the Hepatitis C Virus Nucleic Acid Genotyping Test Kit
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第209号-f4
Registration & Filing
2017-12-22
2017-12-14
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 Examination of Four Registration Technologies, including the Human Epidermal Growth Factor Receptor 2 Gene Amplification Detection Kit (Fluorescence in situ Hybridization Method)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2017年第209号-f3
Registration & Filing
2017-12-22
2017-12-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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