January 14, 2014
BANGALORE, INDIA January 14, 2014 – UL India Pvt. Ltd., a subsidiary of UL (Underwriters Laboratories), a world leader in advancing safety, has been successful in expanding recognition under the IECEE CB Scheme as a Certification Body Test Lab (CBTL) for the most recognized versions of the internationally harmonized safety standard for electromedical devices.
In addition to being a NABL accredited and BIS (Bureau of Indian Standards) recognized laboratory, UL India Pvt. Ltd. (UL India) is a well-established IECEE CB Test Laboratory in many electrical and electronics categories; providing enhanced global market access in conjunction with UL’s National Certification Body (NCB) UL Demko to issue CB test certificates (CBTC) accepted by other CB Scheme members around the world to issue local certification marks.
The expansion of UL India’s CBTL scope to include the 2nd and 3rd editions of IEC 60601-1 with Amendments and several particular standards for medical electrical equipment reinforces UL’s recognition of the importance of the medical device industry in India and helps ensure UL continues to provide a high quality and recognized pathway to international compliance. India medical device manufacturers can now take full advantage of UL local test and advisory service capabilities to support global regulatory approvals directly through the Bangalore office.
“We understand that the local industry needs a trusted, local resource for testing and certification,” said Suresh Sugavanam, Vice President and Managing Director, South Asia. “Now that UL has expanded its CBTL status in India to include the Medical (MED) category, local manufacturers forming part of our key client base can continue to work with our competent engineers and have their compliance needs fulfilled in the local time zone.”
IEC 60601-1 is the internationally harmonized safety standard for electromedical equipment. In order to receive approval in global markets, manufacturers of higher risk medical devices must demonstrate their safety and effectiveness through the submission of test data. Many of the regulators around the world recognize the IEC 60601-1 series of standards as a means of demonstrating device safety.
“The medical device industry is extremely competitive and the India market has consistently been a region of innovation in medical devices” said Jerry Stricker, GM and Vice President, UL Life & Health Business Unit. “By investing in CB Scheme certification, manufacturers increase their ability to compete on a global level and UL customers can also leverage the global recognition of UL’s network of laboratories and accreditations.”
To learn more about UL’s comprehensive testing, certification and advisory services to support global market access, visit www.ul.com
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