UL Provides Medical Device Manufacturers Alternative to Traditional CFDA Testing

Mar 09, 2016, 12:18 ET from UL

MOUNDS VIEW, Minn., March 9, 2016 /PRNewswire/ -- UL, a global safety science organization, today 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. 

To find out more information on UL's CFDA testing program visit http://industries.ul.com/medical-and-laboratory/medical-devices/china-food-drug-administration-local-testing-at-ul, call 1.888-503-5537 or email Medical.Inquiry@ul.com.

About UL

UL is a premier global independent safety science company that has championed progress for more than 120 years. Its nearly 11,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL uses research and standards to continually advance and meet ever-evolving safety needs. We partner with businesses, manufacturers, trade associations and international regulatory authorities to bring solutions to a more complex global supply chain. For more information about our certification, verification, validation, testing, inspection, advisory and education services, visit http://www.UL.com.

Nicole Botich
UL LLC Health Sciences division

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