DQS Malaysia proudly announces that Biovic has successfully achieved certification under the Medical Device Single Audit Program (MDSAP). This accomplishment signifies that Biovic's quality management system (QMS) meets the stringent requirements of multiple global regulatory authorities, United States FDA and Brazil's ANVISA.
MDSAP enables medical device manufacturers to undergo a single audit that satisfies the regulatory requirements of these five countries (United States, Canada, Japan, Brazil, and Australia). This streamlined approach reduces the need for multiple inspections, facilitating smoother market access and regulatory compliance.
By obtaining MDSAP certification, Biovic demonstrates its commitment to maintaining high-quality standards and regulatory compliance across key international markets.
DQS Malaysia extends its congratulations to Biovic on this significant achievement and remains dedicated to supporting the medical device industry in meeting global regulatory standards.