CHINA’S MEDICAL DEVICE REGULATIONS HAVE BEEN EVOLVING
According to a China Medical Pharmaceutical Material Association (CMPMA) report, 2015 sales of medical devices in China grew 20 percent over 2014.
The China Food and Drug Administration (CFDA) is the regulatory body that approves medical devices for sale in China. The regulatory system is evolving, and there have been several updated regulations in recent years, including revisions to the application process, fees and requirements for software.
UL has a team of in-house experts on the ground in China and has built credibility and relationships with the China Test Laboratories and CFDA to help our customers both in country and outside of China through the testing and submission process.
September 20, 2016: Announcement: Requirements for Specific Medical Equipment
September 29, 2016: Draft: Classification of Medical Devices Directory (Revised Version)
October 26, 2016: Administration Bulletin No. 168: Priority Review and Approval Procedure for Medical Devices
January 24, 2017: Notice No. 13 of 2017: Medical Device Network Security Registration Technical Review Guidelines
February 4, 2017: Announcement No. 11: Publication of YY/T 0287-2017 “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
February 8, 2017: Administration Order No. 29: Medical Device Recall Management Approach
April 6, 2017: Decree No. 32: State Food and Drug Decision o the Adjustment of the Medical Device Approval Process of Administrative Examination and Approval
April 26, 2017: Administration Order No. 33: Administrative Measures for Medical Device Standards