Shanghai NewMed Medical Technologies Co., Ltd. Contributes to the Formulation of National Standard GB/T 44353.2-2024 on Animal-Derived Medical Devices

Animal-Derived Medical Devices, manufactured from animal tissues or materials sourced from animals, exhibit excellent biocompatibility and mechanical properties. These characteristics enable them to be accepted and adapted by human tissues, ensuring stable performance during treatment and enhancing therapeutic outcomes and patients' quality of life. Therefore, to guarantee the quality and safety of medical devices, it is essential to strictly control the sourcing, collection, and processing of animal-derived medical devices. This includes procuring legally reliable animal tissues, ensuring no contamination or damage during collection, and following prescribed procedures and standards for processing to prevent disease transmission and environmental issues.

The release of this national standard not only provides a basis and guidelines for market supervision but also strengthens the standardized management of the sourcing, collection, and disposal of animal-derived medical devices in China. At the same time, this standard will drive companies to continuously innovate in the research and production processes of animal-derived medical devices, enhance the technical content and added value of their products, thereby promoting the sustainable development of the entire medical device industry.

NewMed, as an innovative medical device enterprise, has always focused on the research and development and industrialization of internationally advanced interventional artificial heart valve devices. To date, the company has applied for more than 400 patents and has participated in the formulation and verification of multiple industry standards, national standards, and specifications. As the only corporate entity, it has participated in drafting the "YY/T 1787-2021 Cardiovascular Implants - Heart Valve Repair Devices and Delivery Systems."

In the future, NewMed will continue to uphold the mission of "Innovation Benefits Life," deeply participate in and lead the formulation, wide application, and continuous advancement of industry-related standards. It is committed to integrating the latest scientific research achievements and technological breakthroughs into the standards system, providing patients with safer, more efficient, and personalized treatment solutions, and ushering in a new era of structural heart disease treatment.