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Latest Regulations
1153 Results
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Title
ASC
DESC
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 the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Disposable Surgical gowns
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f12
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 Disposable Vacuum Blood Collection Products
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2011]187号-f9
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 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
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