General

New Forces in International Trade! On June 25, it was reported that Midea Group (000333) announced that its Wandong Medical (600055) Superconducting Magnetic Resonance Imaging System had obtained the CE certificate issued by TUV Rheinland Group, an EU announcement body, becoming the first Chinese enterprise to obtain the superconducting magnetic resonance MDR certificate under the new EU medical regulations, marking that it had obtained the "visa" to enter the European market and promoting the development of international trade.

According to the official website, CE certification is a mandatory requirement for product access in the EU market. The Medical Device (MDR) Regulation (EU) 2017/745 was issued in May 2017 and officially replaced the original EU Medical Device Directive (MDD, 93/42/EEC) on May 26, 2021. Intended to establish a more modern and strict legal framework to better protect the health and safety of the public and patients.

It is understood that Wandong Medical Imaging products cover MRI, CT, DSA, DR, DRF, digital breast machines, mobile DR, and ultrasound diagnostic equipment, providing combined solutions to clinical practice. In 2022, Wandong developed liquid helium free superconducting magnetic resonance, which is a strategic product for the superconducting product line.

This time, Wandong Medical has become the first enterprise in China to obtain the superconducting MDR certificate, indicating that the professionalism and quality management system of Chinese enterprises are more complete. The image quality, stability, and reliability of domestically produced superconducting magnetic resonance have been internationally recognized, and have the ability to enter a wider international trade market. This has established a good beginning for Chinese imaging enterprises represented by Wandong Medical to further explore the European market and serve global users, Promote the development of international trade.

At present, the country advocates to solve the problem of "bottleneck" in the industrial chain. High performance medical devices are one of the ten key industrial areas clearly defined in China's "manufacturing power strategy". In the future, the difficulties in core technology of MRI equipment are expected to be overcome one by one. This time, Wandong Medical won the first superconducting magnetic resonance MDR certificate under the new medical regulations of the European Union, which also symbolizes that the domestic superconducting MRI technology is about to enter the international trade arena.