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Latest Regulations
1153 Results
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Guidelines for registration review of dental desensitizers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第102号-f8
Registration & Filing
2021-12-16
2021-12-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Microwave Ablation Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第93号-f3
Registration & Filing
2021-12-13
2021-11-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Endoscopic Surgical Power Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第93号-f4
Registration & Filing
2021-12-13
2021-11-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Operational Norms for Communication and Exchange of Technical Review and Evaluation of Innovative Priority Medical Device Registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20211202
Registration & Filing
2021-12-02
2021-12-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
UNKNOWN
UNKNOWN
Notice on Matters Related to Payment of Fees for Medical Device Registration Application (No. 16, 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2021年第16号
Registration & Filing
2021-12-01
2021-12-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Notice of the National Medical Products Administration on Issuing the Guiding Principles for Registration Review of Neuro and Cardiovascular Surgical Instruments - Knives, Scissors, and Needles (No. 92 of 2021)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第92号
Registration & Filing
2021-12-01
2021-11-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Clinical Trials of Non original Accompanying Diagnostic Reagents for Antitumor Drugs
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第95号-f1
Registration & Filing
2021-12-01
2021-11-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Guiding principles for registration review of overseas clinical trial data using in vitro diagnostic reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第95号-f2
Registration & Filing
2021-12-01
2021-11-26
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Guidelines for Registration Review of Clinical Trial Data Submission Requirements for Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第91号-f1
Registration & Filing
2021-11-25
2021-11-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Guidelines for Registration Review of Clinical Trial Data Submission Requirements for In Vitro Diagnostic Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第91号-f2
Registration & Filing
2021-11-25
2021-11-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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