On February 27, 2024, the white blood cell filter blood transfusion equipment and white blood cell filter products independently developed by Shuangwei Biology officially passed MDR certification and obtained MDR CE certificate issued by TUV Nande. More stringent access standards MDR CE comprehensive upgrade.

In order to better protect patient safety and public health, medical devices have ushered in a new regulatory change, which has been upgraded to MDR regulations since May 2017. This upgrade to the MDR regulations pays more attention to clinical performance, medical device traceability and transparency, and puts forward more stringent requirements for product quality management processes and risk management systems, including comprehensive clinical evaluation certificates-so that medical devices entering the European market will be subject to stricter restrictions. By the end of 2023, the MDR regulatory certification pass rate of the notified body was only 25%.

In order to ensure that the core product-disposable white blood cell filter blood transfusion equipment successfully completed MDR CE certification, the company set up a special team to tackle key problems, the project team in the face of difficulties and adjustments, showed a tenacious fighting spirit and team cooperation ability. The team carried out effective quality control and formulated detailed hierarchical risk management measures from various stages such as legal interpretation, risk analysis, clinical evaluation, and performance evaluation. With the team's high professionalism and sense of responsibility, the team ensured the stable progress of the project.

Only with a high threshold can there be high gold content. Shuangwei's winning of the highly difficult MDR certificate is not only an important proof of the company's technological research and development ability and innovation ability, but also will significantly enhance the company's recognition and professionalism in the international market.

As a well-known medical device manufacturer that has been deeply engaged in the field of safe blood transfusion for 30 years, Sunway takes creating "safe, efficient, high-quality, and advanced" medical devices as its own responsibility, and is committed to promoting the development of blood transfusion industry technology, creating high quality medical device products, and improving The influence of "Created in China" in the international scope has opened a new chapter for the company's development in the international market.

Let's forge ahead and start again. Shuangwei Biology will take this as a new development opportunity to further deepen the global market layout and contribute to the global medical industry!