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Latest Regulations
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ASC
DESC
Guidelines for Registration Review of Fecal occult blood (FOB) Detection Kit (Colloidal Gold Immunochromatography) (Revised 2023 Edition) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-52
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration Review of Electronic Blood Pressure Gauges (Oscillographic Method) (Draft for Soliciting Opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-53
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Biochemical Analyzers (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-54
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Creatine Kinase Testing Reagents (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-28
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration Review of Alkaline Phosphatase Testing Reagents (Revised 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-46
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration Review of Hemodialysis Water Production Equipment (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-47
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Triglyceride Testing Reagents (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-48
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration and Review of Peritoneal Dialysis Equipment (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-41
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of C-reactive Protein Assay Kit (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-42
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration Review of Medical Image Storage and Transmission System Software (PACS) (Revised 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-43
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
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