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Latest Regulations
1153 Results
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Notice on Receiving Paper Materials for Self Withdrawal of Medical Device Registration Application Projects (No. 4, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第4号
Registration & Filing
2021-03-17
2021-03-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Announcement of the National Medical Products Administration on the Registration of Main Documents for Medical Devices (No. 36 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE公告2021年第36号
Registration & Filing
2021-03-12
2021-03-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Interpretation of the Announcement on Registration Matters of Medical Device Master Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20210312
Registration & Filing
2021-03-12
2021-03-12
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notice on Matters Related to the Registration of Medical Device Master Documents (No. 2, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第2号
Registration & Filing
2021-03-12
2021-03-12
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Technical Review of Three Registration Technologies, including IgM/IgG Antibody Testing Reagents for Mycoplasma Pneumonia
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第4号
Registration & Filing
2021-01-19
2021-01-18
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 Guiding Principles for the Review of Three Registration Technologies, including Cryptococcus capsular polysaccharide antigen detection reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第4号-1
Registration & Filing
2021-01-19
2021-01-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice of the National Medical Products Administration on Issuing Three Registration Technical Review Guidelines for Genetic Deafness Related Gene Mutation Detection Reagents and Other Matters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第4号-2
Registration & Filing
2021-01-19
2021-01-18
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 Guiding Principles for Technical Review of Fundus Camera Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第87号-1
Registration & Filing
2020-12-21
2020-12-17
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 the Guiding Principles for Technical Review of Electronic Upper Gastrointestinal Endoscopy Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第87号
Registration & Filing
2020-12-21
2020-12-17
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Matters Related to Consultation on Technical Evaluation and Correction of Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2020年第24号
Registration & Filing
2020-12-10
2020-12-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
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