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Latest Regulations
13 Results
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Issue Date
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Oldest
Title
ASC
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Notice on Adjusting the Business Scope of the Electronic Declaration Information System for Medical Device Registration (No. 7, 2024)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2024年第7号
Registration & Filing
2024-02-05
2024-02-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
UNKNOWN
UNKNOWN
Notice on Adjusting the Business Scope of the Electronic Declaration Information System for Medical Device Registration (No. 11, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第11号
Registration & Filing
2023-04-19
2023-04-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Notice on Consultation on Digital Authentication (CA) Certificate of Medical Device Registration Electronic Declaration Information System
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20221114-1
Registration & Filing
2022-11-14
2022-11-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notice on Issuing the Folder Structure of the Electronic Declaration Catalog for Medical Device Registration (No. 15, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第15号
Registration & Filing
2021-11-15
2022-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
Medical Device
Notice on the Trial Implementation of Electronic Signature for Registration and Application Materials of Imported Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200929-3
Registration & Filing
2020-09-29
2020-09-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notice on Matters Related to the Updating of Digital Authentication Certificates in the Electronic Declaration Information System for Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20200518
Registration & Filing
2020-05-18
2020-05-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notice on the Related Submission and Prohibition of Repeated Submission of Electronic Declaration for Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2019年第15号
Registration & Filing
2019-10-14
2019-10-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Notice of the National Medical Products Administration on the Requirements for Electronic Declaration of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第41号
Registration & Filing
2019-07-10
2019-08-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Issuing the Folder Structure of the Electronic Declaration Catalogue (RPS ToC) for Medical Device Registration Electronic Declaration Information System
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2019年第5号
Registration & Filing
2019-06-06
2019-06-06
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
CMDE/Center for …
Announcements
IVD
Notice on Matters Related to the Business Processing of the Electronic Declaration Information System for Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2019年第4号
Registration & Filing
2019-06-06
2019-06-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
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