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Latest Regulations
1153 Results
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Title
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Notice on Guiding Principles for Issuing Registration and Application Materials for Self testing Blood Glucose Monitoring Systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2010]438号
Registration & Filing
2010-10-18
2010-10-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Guiding Principles for Issuing Registration and Application Materials for Passive Implantable Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2009]519号-f1
Registration & Filing
2009-12-30
2009-12-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Adjusting the Management of Medical Indoor Air Disinfection Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2009]582号
Manufacturing,Registration & Filing
2009-09-10
2009-09-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Guiding Principles for Technical Review of Product Registration of B-type Ultrasound Diagnostic Equipment (Class II)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2009]231号
Registration & Filing
2009-06-18
2010-06-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice on soliciting opinions online on the series of guiding principles for performance evaluation of in vitro diagnostic reagents (draft for soliciting opinions)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20090601
Registration & Filing
2009-06-01
2009-06-01
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
Guidelines
IVD
Explanation on issues related to registration of X-ray diagnostic products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20090421
Registration & Filing
2009-04-21
2009-04-21
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
Announcement on Matters Related to Registration and Testing Reports of Imported Medical Electrical Equipment Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国药监局公告2009年第13号
Registration & Filing
2009-03-23
2009-03-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
UNKNOWN
UNKNOWN
Guiding principles for technical review of tracheal intubation product registration
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2009]95号-f2
Registration & Filing
2009-03-18
2009-03-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guiding Principles for Technical Review of Registration of Gastric Tube Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2009]95号-f4
Registration & Filing
2009-03-18
2009-03-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Guidelines for Writing Registration and Application Materials for Medicated Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20090220
Registration & Filing
2009-02-20
2009-02-20
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Combination Product
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