UL, a global safety science organization, announced the launch of its new China Food and Drug Administration (CFDA) testing program for medical device manufacturers. This program allows medical device manufacturers outside of China the option to participate in and complete the required series of tests for CFDA approval at a local UL laboratory outside of China with the support of onsite engineers from CFDA testing lab.
“We are pleased to be able to provide China market access solutions for our customers as an alternative to the traditional CFDA testing approval process,” said Jack Steiner, North America Operations Manager. “Manufacturers can see the test plan up front, schedule and witness the testing alongside their UL engineer. Our knowledgeable team can leverage our expertise to help advocate on behalf of the manufacturer throughout the process. By partnering with UL many of the delays and risks associated with testing for China can be mitigated in-person and in real-time.”
As part of the regulatory approvals pathway for medical devices, the China Food & Drug Administration (CFDA) requires certain medical devices to complete safety and EMC testing to GB 9706 and YY0505 (based on the IEC 60601-1 series) standards at CFDA authorized laboratories. With its established relationship with CFDA authorized laboratories, UL is able to provide the option to complete the required GB9706 CFDA safety and YY0505 EMC standards testing at many of its laboratories around the world.