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Relationship with authorized CFDA laboratories allows UL to conduct required safety and EMC testing for medical and lab equipment outside of China
With the world’s largest population, and one of the largest and fast growing medical device markets in the world, the prospects for medical device spending in China are huge. The Chinese government has committed heavily in the construction of thousands of hospitals, healthcare centers, clinics and this will inevitably lead to spending on capital goods, most notably medical devices, equipment and furniture at an unprecedented rate in a relatively short space of time. Manufacturers recognize that access to this very important medical device marketplace is extremely important to their global market strategy.
Agreement now allows testing of stationary equipment outside of China
As part of the regulatory approvals pathway for medical devices, the China Food & Drug Administration (CFDA) requires medical devices to complete safety and EMC testing to GB 9706 and YY 0505 (based on the IEC 60601-1 series) standards at CFDA authorized laboratories. Through our established relationship with CFDA authorized test laboratories, UL can arrange for the representative from the authorized CFDA laboratory to come to UL facility to witness the testing while the tests are being performed. Currently this testing program is only for stationary medical devices. This arrangement enables us to provide our clients the ability to complete the required GB 9706 CFDA safety and YY 0505 EMC standards testing at many of our laboratories around the world. Manufacturers can see the test plan up front, schedule the testing and can attend the testing alongside their UL engineer. By working with UL to complete the necessary safety testing for CFDA submission, you can expect the high quality testing services and expert knowledge UL is known for. We understand the business opportunity for medical device manufacturers currently have to enter China’s medical device market, and look forward to making the process of completing the CFDA required testing transparent and more efficient.
UL CFDA Testing Services
*Note that currently this program is only for stationary medical devices
- Pre-tests/Gap assessment – Prior to CFDA authorized test laboratory travel, UL will review the current test data if available and conduct tests to help allow for any mitigation and redesign prior to testing.
- Test Reports – In order to streamline the testing, UL can create the applicable China-based standard report and provide it to CFDA authorized test laboratory prior to their visit.
- Confirm test plan – UL can provide any developed test plans to the CFDA authorized test laboratory. This will allow the CFDA authorized test laboratory to provide guidance on testing that will be conducted during the visit.
- Logistics – UL will arrange all the logistics and visa application invitations letter for the CFDA authorized test laboratory to travel to the test facility.
- Product Technical Requirements (PTR) documentation – UL can work with the CFDA authorized test laboratory to develop your PTR which is necessary for your CFDA submission
Benefits for Manufacturers
- Time Savings – Currently, testing can take up to two years to complete. By testing with UL, you will have better control of your timeline by knowing when the testing will be done.
- Shipping in Country – Less travel and logistics associated with sending samples to China for safety testing.
- Design Mitigation – Ability to have your design engineers on site while the testing is being done and able to make immediate changes, reducing impact to project timelines.
- Transparency – Reduction of ambiguity in knowing the test plan up front.
- Possibility of Testing at Manufacturer- Specialized tests can be performed at the manufacturer’s site and witnessed by CFDA authorized test laboratory (additional review of the lab will be necessary before the visit) If testing at your location is of interest, speak with the UL team
For more information call 1.888.503.5537 or email Medical.Inquiry@ul.com.