Quality Standards & Compliance

ISO 13485:2016 is the globally recognized standard for quality management systems (QMS) specific to the medical devices industry. For dental laboratories in Vietnam, achieving ISO 13485 certification is a strategic milestone that ensures consistent product quality, regulatory compliance, and enhanced patient safety.

The U.S. Food and Drug Administration (FDA) plays a critical role in regulating the safety, efficacy, and quality of medical devices, including dental products, imported into the United States. For Vietnamese dental laboratories, compliance with FDA regulations is essential to ensure seamless market entry and long-term success in serving U.S. dental practices.