Log in Sign Up
FILTER
Product Life Cycle
Status
Level of Legal Effect
Product Categories
Issuing Organization

Latest Regulations

67  Results

Announcement of the State Administration on the Approval and Release of 40 Medical Device Industry Standards, including "Biological Evaluation of Oral Medical Devices Part 7: Pulp and Dentin Application Tests"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第38号 Product Type Testing 2017-03-28 2017-04-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on approving the release of 10 medical device industry standards, including "Test Methods for Contact Wound Dressings Part 5: Antibacterial Resistance"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第25号 Product Type Testing 2017-02-28 2018-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements Medical Device
YY/T0287-2017idtISO13485:2016 "Medical Device Quality Management System - Requirements for Regulatory Purposes" Standard Interpretation (II)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170204-2 Product Type Testing 2017-02-04 2017-02-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
YY/T0287-2017idtISO13485:2016 "Medical Device Quality Management System - Requirements for Regulatory Purposes" Standard Interpretation (I)
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20170204-1 Product Type Testing 2017-02-04 2017-02-04
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Work Documents IVD
Announcement of the State Administration on approving the release of YY/T0287-2017 "Requirements for Regulatory Use of Medical Device Quality Management Systems" medical device industry standards
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2017年第11号 Product Type Testing 2017-01-19 2017-05-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Announcement of the State Administration on approving the release of 64 medical device industry standards, including YY0017-2016 Metal Orthopedic Plate for Bone Joint Implants
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第129号 Product Type Testing 2016-07-29 2017-06-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
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
Announcement of the State Food and Drug Administration on approving the release of 93 medical device industry standards and 1 amendment form, including YY0065-2016 "Ophthalmic Instrument Slit Lamp Microscope"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2016年第25号 Product Type Testing 2016-01-26 2016-01-26
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
Interpretation of Medical Device Registration Management Regulations Part 5
Regulation No. Product LifeCycle Issued Date Implemented Date CFDA-20151119 Product Type Testing 2015-11-19 2015-11-19
Status Issued By Level of Legal Effect Product Category Obsolete NMPA/National Medical … Work Documents IVD
Announcement of the State Food and Drug Administration on approving the release of 90 medical device industry standards, including YY0572-2015 "Water for Hemodialysis and Related Treatment"
Regulation No. Product LifeCycle Issued Date Implemented Date 总局公告2015年第8号 Product Type Testing 2015-03-02 2016-01-01
Status Issued By Level of Legal Effect Product Category Valid NMPA/National Medical … Announcements IVD
  1. «
  2. 1
  3. 2
  4. 3
  5. 4
  6. 5
  7. 6
  8. 7
  9. »

About Us

Contact Us

Privacy Policy

Term of Use

Regulatory Database

Learning Portal

Sign Up for News

Copyright©2023     京ICP备2023016530号-1