Program allows medical device manufacturers to meet quality management system requirements for multiple geographies in one audit.
FREMONT, Calif., Aug. 14, 2017 – UL (Underwriters Laboratories), a global safety science organization, announced today it has successfully completed its assessment and received confirmation by the Regulatory Authorities of the Medical Device Single Audit Program (MDSAP) as a Recognized Auditing Organization (AO). MDSAP is based on the International Medical Device Regulatory Forum’s (IMDRF) program documentation. Members of MDSAP include the US Food and Drug Administration (FDA),Therapeutic Goods Administration of Australia (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, Japan’s Ministry of Health, Labour and Welfare (MHLW), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
The MDSAP allows a Recognized Auditing Organization to conduct independent MDSAP audits on behalf of the coalition of regulatory authorities including the U.S., Canada, Japan, Brazil and Australia. This single audit approach reduces the need for duplicate quality management audits, helping device manufacturers to better manage costs and ease market access.
“MDSAP will help streamline the regulatory approvals process and take a lot of the burden off of manufacturers that had to endure audits from multiple regulatory bodies,” said Michael Windler, Regulatory Service Manager, UL Health Sciences division. “Our team of in-house auditors, who specialize in medical devices and standards have over nine years of experience on average which means it will take them less time to learn the nuances of highly innovative medical products and complex regulations.”
MDSAP is already a strong regulatory driver for manufacturers selling devices in Canada. After January 1, 2019, it will replace the current Canadian Medical Devices Conformity Assessment System (CMDCAS) program. During the transition, Health Canada will accept certificates issued under both MDSAP and CMDCAS. UL will be leading a 30-minute live webinar on Wednesday August 16th covering the MDSAP requirements. Registration is free online at: http://connect.ul.com/Canadas-2019-transition-from-CMDCAS-to-MDSAP-Registration.html
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