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Latest Regulations
995 Results
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Guidelines for Registration Review of Drug Abuse Testing Reagents (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第4号-f3
Registration & Filing
2024-01-18
2024-01-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for the Registration and Review of Real World Research Design and Statistical Analysis of Medical Devices (No. 3, 2024)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第3号
Registration & Filing
2024-01-15
2024-01-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Registration and Review of Peripheral Vascular Stent Systems (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20240111
Registration & Filing
2024-01-11
2024-01-10
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for the registration and review of nucleic acid testing and typing reagents for herpes simplex virus (HSV)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第2号-f1
Registration & Filing
2024-01-04
2024-01-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for the Registration and Review of Adhesion Testing Reagents for Toxoplasma gondii, Rubella virus, Cytomegalovirus, Herpes simplex virus Antibodies, and G-type Immunoglobulin Antibodies (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第2号-f2
Registration & Filing
2024-01-04
2024-01-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guiding Principles for Registration Review of Main Raw Materials for In Vitro Diagnostic Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f1
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 Brucella IgM/IgG Antibody Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第1号-f2
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 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
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