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Latest Regulations
12 Results
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ASC
DESC
Announcement of the National Medical Products Administration on the Comprehensive Implementation of Electronic Registration Certificates for Medical Devices (No. 91 of 2022)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2022年第91号
Registration & Filing
2022-10-26
2022-10-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Carrying out Information Confirmation of Medical Device Registration Certificate and Its Attachments (No. 9 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第9号
Registration & Filing
2021-06-04
2021-06-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Format of electronic registration change document for medical devices (in vitro diagnostic reagents) (draft for soliciting opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210525-1-f4
Registration & Filing
2021-05-25
2021-05-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
Format of electronic registration change document for medical devices (draft for soliciting opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210525-1-f3
Registration & Filing
2021-05-25
2021-05-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
Medical Device
Format of Electronic Registration Certificate for Medical Devices (In Vitro Diagnostic Reagents) (Draft for Solicitation of Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210525-1-f2
Registration & Filing
2021-05-25
2021-05-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
IVD
Format of Electronic Registration Certificate for Medical Devices (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20210525-1-f1
Registration & Filing
2021-05-25
2021-05-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
NMPA/National Medical …
Work Documents
Medical Device
Announcement on the issuance of drugs, medical devices, cosmetics, and GCP approvals
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第249号
Registration & Filing
2019-09-04
2019-09-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Adjusting the Delivery Method of Administrative Licensing Documents for Some Medical Device Application Matters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第12号
Registration & Filing
2019-08-30
2019-08-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Explanation on Relevant Issues Concerning the Delivery of Proof Documents for the Approval Results of Administrative Licensing Matters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20190820-1
Registration & Filing
2019-08-20
2019-08-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement on the Delivery Procedure of Proof Documents for the Approval Results of Administrative Licensing Matters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第243号
Registration & Filing
2019-07-04
2019-08-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
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