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Latest Regulations
29 Results
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Notes on registration and application of respiratory intubation products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20120316
Registration & Filing
2012-03-16
2012-03-16
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices, including influenza Virus Nucleic Acid Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]540号-f1
Registration & Filing
2011-12-23
2011-12-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice on Issuing the Guiding Principles for the Registration and Application Materials of Two Medical Devices Including influenza Virus Antigen Testing Reagents
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]540号-f2
Registration & Filing
2011-12-23
2011-12-23
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
Notice on Issuing 9 Guiding Principles, including Registration and Application Materials for Quantitative Detection Reagents of Tumor Markers
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f7
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
IVD
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
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
Notice on Issuing Requirements for Research and Application of Organizational Engineering Medical Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
国食药监械[2007]762号
Registration & Filing
2007-12-18
2007-12-18
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Writing of Product Technical Report in Registration Application Materials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20071130
Registration & Filing
2007-11-30
2007-11-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Work Documents
Medical Device
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