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Latest Regulations
1153 Results
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Title
ASC
DESC
Guiding Principles for Registration Review of Respiratory Tube Products for Anesthesia and Respiratory Machines (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f10
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Technical Review of Registration of Detection Reagents Used in Flow Cytometers (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f11
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
IVD
Guidelines for Registration Review of Disposable Nasal Oxygen Tube (Revised 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f12
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Registration Review of Disposable Drainage Tube Products (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f13
Registration & Filing
2023-04-25
2022-05-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Registration Review of Disposable Sterile Surgical Bag Products (Revised in 2023)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20230425-f14
Registration & Filing
2023-04-25
2023-04-25
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
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
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