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Latest Regulations
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Guidelines for registration and review of circumcision staplers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局通告2021年第102号-f7
Registration & Filing
2021-12-16
2021-12-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
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 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
Interpretation of the Guiding Principles for Registration and Review of Medical Device Animal Experiment Research
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
NMPA-20211122-1
Registration & Filing
2021-11-22
2021-11-22
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Work Documents
Medical Device
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