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Latest Regulations
1220 Results
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Title
ASC
DESC
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Natural Rubber Latex and Rubber Condom Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f11
Registration & Filing
2011-05-11
2011-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including 3A Class Semiconductor Laser Therapy Machine Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f3
Registration & Filing
2011-05-11
2011-05-11
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing 9 Guiding Principles for Technical Review of in vitro Diagnostic Reagent Analysis Performance Evaluation (Accuracy Recovery Test)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f6
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 Issuing 9 Guiding Principles for Technical Review of in vitro Diagnostic Reagent Analysis Performance Evaluation (Accuracy Methodology Comparison)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f5
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 Issuing 9 Guiding Principles including Technical Review for Registration of Contact Lens Care Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f1
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing 9 Guiding Principles including Technical Review for Registration of Breast Implant Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]116号-f2
Registration & Filing
2011-03-24
2011-03-24
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
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
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
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