Quality & Compliance
BrosMed Medical has established a high-standard quality management system that meets global standards.
At BrosMed, quality is more than a requirement—it is our commitment to protecting lives. Delivering safe, reliable, and effective products to patients is the guiding principle behind every aspect of our operations. We maintain a robust quality management system that complies with international standards and regulatory requirements, including ISO 13485, China GMP for Medical Devices, U.S. FDA 21 CFR Part 820, and Japan MHLW Ministerial Ordinance No. 169. BrosMed has successfully passed multiple inspections and audits conducted by leading regulatory authorities and notified bodies, including the NMPA, FDA, PMDA, BSI, and TÜV. In recognition of our consistent commitment to quality, the company has been awarded the title of Class A Quality Credit Medical Device Enterprise in Guangdong Province for five consecutive years. By upholding the highest standards of quality, compliance, and continuous improvement, BrosMed strives to ensure that every product delivered contributes to better patient care and outcomes.