Dongguan-June 21, 2023-Today BrosMed announced that it has earned the Medical Device Single Audit Program (MDSAP) certification, indicating that the single regulatory audit to BrosMed satisfies the requirements of multiple regulatory jurisdictions participating in the program.
The MDSAP is a unique program that brings the internationally leading regulatory agencies together to perform a single regulatory audit of a medical device manufacturer´s quality management system to satisfy the requirements of multiple regulatory jurisdictions, including the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare and Japanese Pharmaceuticals and Medical Devices Agency, and the U.S. Food and Drug Administration. This certification confirms BrosMed’s compliance with the high standards and regulatory requirements of most leading countries in the world.
“This certification is a key achievement for us on the road to global commercialization. It is a critical step forward in offering our intravascular interventional solutions to additional markets and reinforces our commitment to quality and safety,” said Winnie Huang, BrosMed Quality Director.
At present, BrosMed has more than 20 product series sold to over 80 countries and regions. BrosMed will continue to reinforce our commitment to high-standard quality and safety and provide more innovative products for patients around the globe.