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Latest Regulations
995 Results
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ASC
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Notice on Issuing the Guiding Principles for Technical Review of Registration of 12 Medical Device Products, including Surgical Power Equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2012]210号-f8
Registration & Filing
2012-05-10
2012-05-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Issuing Technical Review Guidelines for the Registration of 12 Medical Device Products, including Respiratory Pipelines for Anesthesia and Respiratory Machines
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监办械函[2012]210号-f11
Registration & Filing
2012-05-10
2012-05-10
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice on Soliciting Opinions on Three Guiding Principles, including the Technical Guidelines for Registration and Application of Virus-specific IgM Antibody Qualitative Detection Reagents (Draft for Comments)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20120428-2-f1
Registration & Filing
2012-04-28
2012-04-28
Status
Issued By
Level of Legal Effect
Product Category
Draft
CMDE/Center for …
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
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