On August 30, 2024, VitaVitro Biotech received the first EU Medical Device Regulation (MDR) certificate for assisted reproductive medical devices issued by a domestic manufacturer. The certification was granted by BSI, confirming that VitaVitro’s quality management system complies with the requirements of the MDR.
VitaVitro Biotech began implementing the EU Medical Device Regulation (MDR) certification process in 2018, and in March 2020, the company obtained the CE Quality Management System certificate under the Medical Device Directive (MDD). The recent re-certification under the MDR confirms that the company’s quality management system continues to meet the evolving regulatory requirements of CE. Compared to MDD, the MDR introduces more stringent requirements across all stages from research and development to post-market surveillance, posing greater challenges for companies. The successful acquisition of the MDR certification reflects VitaVitro's ongoing commitment to regulatory compliance and its ethos of continuous self-improvement.
Since 2018, VitaVitro Biotech has undergone six consecutive years of regulatory scrutiny under EU regulations, successfully passing annual quality management audits and unannounced inspections. The company promptly transitioned from the MDD to the MDR regulatory framework, with the quality management system undergoing an MDR audit in 2022, followed by full regulatory oversight under the MDR.
This certification further demonstrates VitaVitro’s adherence to its corporate culture of "quality-first, regulatory compliance, technological innovation, and customer-centricity." It also highlights the company’s international strength in the research, development, and manufacturing of assisted reproductive products.
VitaVitro will continue to deepen its understanding of global regulations, including the MDR, and continually improve its quality management system. The company will continue to align its product development and production processes with international regulatory standards and clinical requirements, ensuring the delivery of high-quality products that meet the needs of global markets.