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Latest Regulations
1061 Results
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Guidelines for Technical Review of Real time Fluorescence PCR Analyzer Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第24号-f2
Registration & Filing
2021-04-15
2021-04-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guidelines for Technical Review of Registration of Rotavirus Antigen Testing Agents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第24号-f3
Registration & Filing
2021-04-15
2021-04-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Guidelines for Technical Review of Registration of Group B Streptococcus Nucleic Acid Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第24号-f4
Registration & Filing
2021-04-15
2021-04-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Guidelines for Technical Review of Registration of Human Parvovirus B19IgM/IgG Antibody Detection Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第24号-f5
Registration & Filing
2021-04-15
2021-04-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Guidelines for Technical Review of Low Temperature Gas Sterilizer Registration (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20210317-f4
Registration & Filing
2021-03-17
2021-03-17
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Technical Review of Registration of X-ray Imaging Devices for Pediatric Applications (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20210317-f8
Registration & Filing
2021-03-17
2021-03-17
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Technical Review of Registration of Anti Mueller's Hormone Assay Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20210317-f9
Registration & Filing
2021-03-17
2021-03-17
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 Three Registration Technologies, including IgM/IgG Antibody Testing Reagents for Mycoplasma Pneumonia
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第4号
Registration & Filing
2021-01-19
2021-01-18
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 Three Registration Technologies, including Cryptococcus capsular polysaccharide antigen detection reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第4号-1
Registration & Filing
2021-01-19
2021-01-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Genetic Deafness Related Gene Mutation Detection Reagents and Other Matters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第4号-2
Registration & Filing
2021-01-19
2021-01-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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