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Latest Regulations
56 Results
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Technical Review Points for Clinical Trial Data of Human SDC2 Gene Methylation Detection Reagent
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第10号-f1
Clinical Evaluation
2022-03-14
2022-03-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
IVD
Technical evaluation points for clinical trial data of abnormal prothrombin assay reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第10号-f2
Clinical Evaluation
2022-03-14
2022-03-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
IVD
Key points for technical evaluation of clinical trial data of Helicobacter pylori 23S rRNA gene mutation detection reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第10号-f3
Clinical Evaluation
2022-03-14
2022-03-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
IVD
Key points for technical review of registration of novel coronavirus antigen detection reagent (trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2022年第10号-f4
Clinical Evaluation
2022-03-14
2022-03-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Review Key Points
IVD
Notice of the National Medical Products Administration on Issuing Technical Guidelines for Clinical Trials of In Vitro Diagnostic Reagents (No. 72 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第72号
Clinical Evaluation
2021-09-27
2021-09-16
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the National Medical Products Administration on Issuing the Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (Revised in 2020)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第61号
Clinical Evaluation
2020-09-18
2020-09-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Revision Explanation of the Catalogue of Class III Medical Devices Subject to Clinical Trial Approval (2020 Revision)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20200918-1
Clinical Evaluation
2020-09-18
2020-09-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Medical Device
Notice on Public Solicitation of Opinions on the Guiding Principles for Clinical Trials of Accompanying Diagnostic Reagents of Marketed Antitumor Drugs (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200813-2
Clinical Evaluation
2020-08-13
2020-08-13
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Announcement of the National Medical Products Administration and the National Health Commission on Issuing the Management Regulations for Expanded Clinical Trials of Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2020年第41号
Clinical Evaluation
2020-03-20
2020-03-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Interpretation of the Management Regulations for Expandable Clinical Trials of Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20200320
Clinical Evaluation
2020-03-20
2020-03-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Medical Device
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