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Latest Regulations
1220 Results
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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
Guidelines for Registration and Review of Pathogen Specific M-type Immunoglobulin Qualitative Testing Reagents (Revised)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20220623-f5
Registration & Filing
2022-06-23
2022-06-23
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Circular of the Center for Organic Examination of the State Food and Drug Administration on Issuing the Guidelines for Registration and Examination of Fundus Image Assisted Diagnosis Software for diabetes Retinopathy (No.23 in 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第23号
Registration & Filing
2022-06-02
2022-06-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Naming Common Names of Physical Therapy Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2022年第26号-f2
Registration & Filing
2022-06-02
2022-05-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of CT Image Assisted Detection Software for Pulmonary Nodules
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第21号
Registration & Filing
2022-05-26
2022-05-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Circular of the Center for Organic Examination of the State Food and Drug Administration on Issuing the Key Points for Technical Review on the Change of Raw Materials of Nitrocellulose Membrane for novel coronavirus (2019 nCoV) Antigen Detection Reagent (Trial) (No. 22 in 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第22号
Registration & Filing
2022-05-26
2022-05-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
IVD
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