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Latest Regulations
1220 Results
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Notice on Matters Related to the Application for Digital Authentication (CA) Certificates in the Electronic Declaration Information System for Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20190507
Registration & Filing
2019-05-07
2019-05-07
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
IVD
Notice on the release of two technical review guidelines, including animal experiments on intra-abdominal hernia repair patches
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第18号-f2
Registration & Filing
2019-04-19
2019-04-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the Equipment Review Center on External Consultation Work (No. 2 of 2019)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2019年第2号
Registration & Filing
2019-04-17
2019-04-16
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
IVD
Notice on Issuing Guiding Principles for the Review of Three Registration Technologies, including Dental Vehicle Needles
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第16号-f1
Registration & Filing
2019-04-11
2019-04-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Three Registration Technical Review Guidelines for Disposable Dispensing Syringes and Other Items
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第16号-f2
Registration & Filing
2019-04-11
2019-04-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Three Registration Technical Review Guidelines for Disposable Skin Sutures and Other Items
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第16号-f3
Registration & Filing
2019-04-11
2019-04-03
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on the Release of Four Guiding Principles, including the Technical Review Guidelines for the Registration of High Frequency Ultrasound Diagnostic Devices in Ophthalmology
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第10号-f1
Registration & Filing
2019-03-26
2019-02-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Four Guiding Principles, including the Technical Review Guidelines for the Registration of Dual Energy X-ray Bone Densitometers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第10号-f2
Registration & Filing
2019-03-26
2019-02-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Four Guiding Principles for Technical Review of Anesthesia Machine Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第10号-f3
Registration & Filing
2019-03-26
2019-02-28
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Four Registration Technical Review Guidelines for Brain Natriuretic Peptide/Amino Terminal Brain Natriuretic Peptide Pre examination Test Agents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2019年第11号-f1
Registration & Filing
2019-03-13
2019-03-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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