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Latest Regulations
165 Results
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Technical Guidelines for Clinical Evaluation of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第73号-f1
Clinical Evaluation
2021-09-28
2021-09-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
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 Technical Guidelines for Clinical Evaluation of In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 74 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第74号
Clinical Evaluation
2021-09-24
2021-09-18
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 In Vitro Diagnostic Reagents Exempted from Clinical Trials (No. 70, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第70号
Clinical Evaluation
2021-09-18
2021-10-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice of the National Medical Products Administration on Issuing the Catalogue of Medical Devices Exempted from Clinical Evaluation (No. 71 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第71号
Clinical Evaluation
2021-09-18
2021-10-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Clinical Evaluation of Same Variety of Intravascular Catheters (No. 68 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第68号
Clinical Evaluation
2021-09-07
2021-09-02
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Interpretation of the Guiding Principles for Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210827
Clinical Evaluation
2021-08-27
2021-08-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Guiding Principles for Safety and Efficacy Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第65号
Clinical Evaluation
2021-08-26
2021-08-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Guidelines for methodological comparison of in vitro diagnostic reagents exempted from clinical trials (draft for comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210519-1-f6
Clinical Evaluation
2021-05-19
2021-05-18
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Guidelines
Medical Device
List of Medical Devices Exempted from Clinical Evaluation (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210519-1-f7
Clinical Evaluation
2021-05-19
2021-05-18
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
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