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Latest Regulations
1882 Results
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Guiding Principles for Registration and Review of Hepatitis C Virus Antibody Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f3
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Zika Virus Nucleic Acid Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f4
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Aspergillus Nucleic Acid Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f5
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration Review of Self testing Blood Glucose Monitoring Systems (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f6
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Quantitative Detection Reagents for Tumor Markers (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f8
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Examination of influenza Virus Nucleic Acid Testing Reagents (2023 Revision)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f9
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Examination of influenza Virus Antigen Testing Reagents (2023 Revision)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f10
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Pathogen Specific M-type Immunoglobulin Qualitative Detection Reagents (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f11
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Hepatitis B Virus Deoxyribonucleic Acid Testing Reagents (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f12
Registration & Filing
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f7
Pre-Market
2024-01-03
2024-01-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
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