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Latest Regulations
995 Results
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Guidelines for Clinical Trial Registration and Review of Colorectal Cancer Related Gene Methylation Detection Kit (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231206-3
Registration & Filing
2023-12-06
2023-12-06
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of ALDH2 Gene Polymorphism Testing Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-1
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Antibiotic Drug Sensitivity Testing Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-2
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Human MTHFR Gene Polymorphism Testing Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-3
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Stability Studies of In Vitro Diagnostic Reagents (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-4
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Technical Review of Hepatitis C Virus Nucleic Acid Testing Reagents (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-5
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Nucleic Acid Testing Reagents for Mycobacterium tuberculosis Composite Group (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-6
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Technical Review of Fully Automatic Chemiluminescence Immunoassay Analyzer (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-7
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Technical Review of Human Red Blood Cell Anti typing Reagent Registration (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-8
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration and Review of Hepatitis B Virus Genotyping Testing Reagents (Revised Draft for Comments in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231201-9
Registration & Filing
2023-12-01
2023-12-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
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