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Latest Regulations
1789 Results
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Technical Review Points for Clinical Trials of Intraperitoneal Endoscopic Surgery System (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230424-f2
Clinical Evaluation
2023-04-24
2023-04-24
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Review Key Points
Medical Device
Notice on Adjusting the Business Scope of the Electronic Declaration Information System for Medical Device Registration (No. 11, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第11号
Registration & Filing
2023-04-19
2023-04-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Announcements
IVD
Guiding principles for registration review of drug coated balloon dilation catheters
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第9号-f1
Registration & Filing
2023-04-13
2023-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Intravascular Recovery Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第9号-f2
Registration & Filing
2023-04-13
2023-04-06
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for registration and review of hernia repair patches
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第9号-f3
Registration & Filing
2023-04-13
2023-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Writing Instructions for Hard Corneal Contact Lenses (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第9号-f6
Registration & Filing
2023-04-13
2023-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Contact Lens Care Products (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第9号-f4
Registration & Filing
2023-04-13
2023-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Writing Instructions for Soft Hydrophilic Contact Lenses (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第9号-f5
Registration & Filing
2023-04-13
2023-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice of the Equipment Review Center of the National Medical Products Administration on Issuing the Guiding Principles for Registration and Review of Radiofrequency Beauty Equipment (No. 8, 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE通告2023年第8号
Registration & Filing
2023-04-12
2023-04-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration and Review of Quantitative Shear Wave Ultrasound Liver Measurement Instruments (No. 7, 2023) issued by the Equipment Review Center of the National Medical Products Administration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230411
Registration & Filing
2023-04-11
2023-04-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
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