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Latest Regulations
1882 Results
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Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Absorbable Surgical Sutures
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f4
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Spinal Posterior Internal Fixation Systems
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f5
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Dental Implants (Systems)
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f1
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Intervertebral Fusion Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f6
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing the Guiding Principles for Technical Review of Registration of Six Medical Devices, including Dental Base Polymer Materials
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第70号-f2
Registration & Filing
2016-04-26
2016-04-14
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Guidelines
Medical Device
Notice of the State Administration on Issuing a Risk List and Inspection Points for the Production Process of 25 Medical Devices, including Disposable Sterile Syringes
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监械监[2016]37号
Manufacturing,Supervision & Inspection
2016-04-13
2016-04-13
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Technical guidelines for clinical evaluation of pulse oximeter equipment
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
CMDE-20160405
Clinical Evaluation
2016-04-05
2016-04-05
Status
Issued By
Level of Legal Effect
Product Category
Valid
CMDE/Center for …
Guidelines
Medical Device
Notice of the State Administration on the Implementation of the Naming Rules for Common Names of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
食药监械管[2016]35号
Pre-Market
2016-03-30
2016-03-30
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Normative Documents
Medical Device
Announcement of the State Administration on the Approval and Release of 93 Medical Device Industry Standards, including YY 0053-2016 "Hemodialysis and Related Treatment Hemodialyzers, Hemodialysis Filters, Hemofilters, and Blood Concentrators"
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局公告2016年第74号
Product Type Testing
2016-03-23
2017-01-01
Status
Issued By
Level of Legal Effect
Product Category
Valid
NMPA/National Medical …
Announcements
Medical Device
Notice of the State Administration on Issuing Six Documents, including the Model Application and Approval Form for Ethical Review of Clinical Trials of Medical Devices
Regulation No.
Product LifeCycle
Issued Date
Implemented Date
总局通告2016年第58号
Clinical Evaluation
2016-03-23
2016-03-15
Status
Issued By
Level of Legal Effect
Product Category
Obsolete
NMPA/National Medical …
Announcements
Medical Device
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