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Latest Regulations
77 Results
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Title
ASC
DESC
Notice of the Comprehensive Department of the National Medical Products Administration on Issuing the Guiding Principles for Independent Software Field Inspection of Medical Device Production Quality Management Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械管[2020]57号
Manufacturing
2020-06-04
2020-05-29
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Notice of the National Medical Products Administration on Issuing the Basic Principles of Safety and Performance of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2020年第18号
Manufacturing
2020-03-10
2020-03-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice of the National Medical Products Administration on Issuing the Implementation Plan for the State Council's Pilot Implementation of the "Separation of Certificates and Licenses" Reform in Free Trade Pilot Zones
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监法[2019]48号
Manufacturing,Distribution,Registration & Filing
2019-11-29
2019-11-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Interpretation of the Rules for the Unique Identification System of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20190827-1
Usage,Distribution,Manufacturing
2019-08-27
2019-08-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration on Issuing Rules for the Unique Identification System of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第66号
Usage,Distribution,Manufacturing
2019-08-27
2019-10-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice from the National Medical Products Administration on the Release of Independent Software for the Appendix of Medical Device Production Quality Management Standards
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第43号
Manufacturing
2019-07-12
2019-07-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Interpretation of the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20190704
Usage,Manufacturing
2019-07-04
2019-07-04
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
IVD
Announcement of the National Medical Products Administration and the National Health Commission on Issuing the Regulations on the Supervision and Administration of Customized Medical Devices (Trial)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2019年第53号
Usage,Manufacturing
2019-07-04
2020-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Notice of the Comprehensive Department of the National Medical Products Administration and the Office of the National Health Commission on Issuing the Pilot Work Plan for the Unique Identification System of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
药监综械注[2019]56号
Supervision & Inspection,Usage,Distribution,Manufacturing
2019-07-03
2019-07-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
IVD
Notice of the State Council on Promoting the Reform of "Separation of Certificates and Licenses" Nationwide
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国发[2018]35号
Manufacturing,Distribution,Registration & Filing
2018-10-10
2018-09-27
Status
Issued By
Level of Legal Effect
Product Category
Valid
State Council …
UNKNOWN
UNKNOWN
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