BrosMed Medical Earned MDSAP Certification
Release time:
2023-06-21
Dongguan, June 21, 2023 — BrosMed today announced that it has received Medical Device Single Audit Program (MDSAP) certification, demonstrating that a single regulatory audit of BrosMed’s quality management system satisfies the requirements of multiple regulatory jurisdictions participating in the program.
Dongguan, June 21, 2023 — BrosMed today announced that it has received Medical Device Single Audit Program (MDSAP) certification, demonstrating that a single regulatory audit of BrosMed’s quality management system satisfies the requirements of multiple regulatory jurisdictions participating in the program.
The MDSAP is a unique program that brings together leading international regulatory authorities to conduct a single regulatory audit of a medical device manufacturer’s quality management system, satisfying the requirements of multiple participating regulatory jurisdictions. These include the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, and the U.S. Food and Drug Administration. This certification reflects BrosMed’s commitment to meeting high quality standards and regulatory requirements in major global markets.
“This certification is a key achievement for us on our path toward global commercialization. It marks an important step forward in bringing our intravascular interventional solutions to additional markets and reinforces our commitment to quality and safety,” said Winnie Huang, Quality Director of BrosMed.
At present, BrosMed has more than 20 product series sold in over 80 countries and regions. BrosMed will continue to uphold high standards of quality and safety while providing more innovative products for patients around the world.
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