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Latest Regulations
1789 Results
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Title
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DESC
Guiding Principles for Registration Review of Salivary Acid Detection Kit (Enzyme Method) (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-33
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
β Guidelines for Registration Review of 2-Microglobulin Testing Reagents (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-34
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 Lactate Dehydrogenase Assay Kit (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-35
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 Thyroid Stimulating Hormone Testing Reagents (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-36
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 Ischemic Modified Albumin Assay Kit (Revised 2023 Edition) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-37
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 Glycated Hemoglobin Assay Kit (Enzyme Method) (Revised 2023 Edition) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-38
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 Vibration Percussion Sputum Ejection Machine (Revised in 2023) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-39
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 Urine Analyzer (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-40
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 the Review of Blood Glucometer Registration (Revised in 2023) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-49
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 Human Chorionic Gonadotropin Testing Reagents (Colloidal Gold Immunochromatography) (Revised 2023 Edition) (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20231025-50
Registration & Filing
2023-10-25
2023-10-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
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