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Latest Regulations
29 Results
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Announcement No. 121 of 2021 on the Requirements for Publishing Registration and Application Materials for Medical Devices and the Format of Approval Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2021年第121号
Registration & Filing
2021-09-30
2022-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the National Medical Products Administration on the Implementation of the Measures for the Administration of Registration and Filing of Medical Devices and the Measures for the Administration of Registration and Filing of In Vitro Diagnostic Reagents (No. 76 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第76号
Registration & Filing
2021-09-29
2021-09-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Announcement of the National Medical Products Administration on Amending the Requirements for Application Materials for Continuing Registration of Medical Devices and Other Parts
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2018年第53号
Registration & Filing
2018-08-23
2018-08-19
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Announcements
IVD
Announcement on Issues Related to Application Materials for Continuing Registration of Medical Devices (including In Vitro Diagnostic Reagents)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CCRCFDA公告2015年第144号
Registration & Filing
2015-03-31
2015-03-31
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
Administrative Acceptance …
Announcements
IVD
Announcement of the State Food and Drug Administration on the Requirements for Publishing Registration and Application Materials for Medical Devices and the Format of Approval Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2014年第43号
Registration & Filing
2014-09-05
2014-10-01
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Announcements
Medical Device
Announcement of the State Food and Drug Administration on the Requirements for the Registration and Application of In Vitro Diagnostic Reagents and the Format of Approval Documents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2014年第44号
Registration & Filing
2014-09-05
2014-10-01
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Announcements
IVD
Announcement of the State Food and Drug Administration on Matters Related to the Filing of Class I Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2014年第26号
Registration & Filing
2014-05-30
2014-05-30
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Announcements
IVD
Basic requirements for registration and application materials of immunohistochemical antibody reagents and detection kits
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20130104
Registration & Filing
2013-01-04
2013-01-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notes on registration and application materials for dental mobile phones and related accessories
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20121116
Registration & Filing
2012-11-06
2012-11-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
Explanation on Basic Requirements for Medical Device Software Registration and Application
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20120428-1
Registration & Filing
2012-04-28
2012-04-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
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