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Latest Regulations
165 Results
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Notice of the National Medical Products Administration on the Technical Guidelines for the Release of Real World Data for Clinical Evaluation of Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第77号
Clinical Evaluation
2020-11-25
2020-11-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice on Public Solicitation of Comments on the Draft Results Document of the Continued Project "Postmarket Clinical Follow up Study" by the IMDRF Medical Device Clinical Evaluation Working Group
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20201021-2
Clinical Evaluation
2020-10-21
2020-10-21
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Work Documents
Medical Device
Notice of the Office of Human Genetic Resources Management of China on Further Optimizing the Administrative Approval Process for Human Genetic Resources
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
MOST-20201021
Clinical Evaluation
2020-10-21
2020-10-19
Status
Issued By
Level of Legal Effect
Product Category
Valid
Ministry of …
Work Documents
IVD
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 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
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
Notice on Soliciting Opinions on the New and Revised Catalogue of Medical Devices Exempted from Clinical Trials in 2020 (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200729-1
Clinical Evaluation
2020-07-29
2020-07-29
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Work Documents
Medical Device
Notice of the National Medical Products Administration on Issuing Seven Registration Technical Review Guidelines for Clinical Evaluation and Quality Control of Spinal Implants
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第31号-f7
Clinical Evaluation
2020-05-09
2020-04-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
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
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
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