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Latest Regulations
1789 Results
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Notice of the Comprehensive Department of the National Medical Products Administration on Further Strengthening the Service Work of Foreign Funded Enterprises
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综科外函〔2022〕361号
Registration & Filing
2022-06-27
2022-06-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Guidelines for Technical Review of Affinity Testing Reagents for Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus Antibodies, and G-type Immunoglobulin Antibodies (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f9
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Technical Review of Gene Mutation Detection Reagents Related to Individualized Tumor Therapy (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f8
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Technical Review of Drug Abuse Detection Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f7
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Hepatitis B Virus Deoxyribonucleic Acid Quantitative Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f6
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Writing Instructions for In Vitro Diagnostic Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f10
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Application of Self testing Blood Glucose Monitoring Systems (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f1
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Application Materials of Quantitative Detection Reagents for Tumor Markers (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f2
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Application Materials of influenza Virus Antigen Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f3
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Application Materials of influenza Virus Nucleic Acid Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f4
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
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