Quality Standards & Compliance

ISO 15189:2022 is a globally recognized standard that specifies requirements for quality and competence in medical laboratories, including dental labs involved in diagnostic testing and laboratory services. For Vietnamese dental laboratories, achieving ISO 15189 certification is a strategic move to enhance credibility, ensure compliance, and unlock international market opportunities.

ISO certification is a vital benchmark for dental laboratories aiming to establish credibility, ensure product quality, and expand into international markets. For Vietnamese dental labs, achieving ISO compliance opens doors to global opportunities, particularly in the highly regulated U.S. market.

Vietnam has emerged as a key player in global dental production, providing high-quality dental materials and services to international markets. With its growing reputation, the country has established regulatory frameworks to ensure the safety, quality, and compliance of dental materials.

In today’s interconnected world, dental practices often rely on international dental laboratories for cost-effective solutions and high-quality products. While these partnerships offer significant advantages, they also introduce complex compliance challenges, particularly concerning the protection of patient health information.

Vietnam has rapidly emerged as a global hub for dental manufacturing, driven by its competitive pricing, skilled workforce, and adherence to international quality standards. At the heart of this success lies the implementation of robust quality control systems, which ensure that products meet the stringent requirements of international markets like the U.S. and Europe.

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.