Domestic superconducting magnetic resonance won the European market "visa" for the first time, and Midea's Wandong Medical won the first MDR certificate in China.

CTOnews.com June 25, Midea announced that its Wandong Medical Superconducting Magnetic Resonance Imaging system has obtained the CE certificate issued by the EU announcement body-TUV Group of Rheinland, becoming the first Chinese company to obtain the Superconducting Magnetic Resonance MDR Certificate under the new EU medical regulations, marking a "visa" to enter the European market.

CTOnews.com obtained from the official website of Wandong Medical that CE certification is a mandatory requirement for product access in the EU market. The Medical device (MDR) Regulation (EU) 2017 Placer 745 was issued in May 2017 and officially replaced the original EU Medical device Directive (MDD,93/42 / EEC) from May 26, 2021. The aim is to establish a more modern and stricter legal framework to better protect the health and safety of the public and patients.

It is understood that Wandong medical imaging products include MRI, CT, DSA, DR, DRF, digital breast machines, mobile DR, ultrasound diagnostic equipment, providing combined solutions to clinic, and developed liquid helium-free superconducting magnetic resonance in 2022, which is a strategic product of the superconducting product line.

As China is a helium-poor country, helium basically depends on imports, the domestic superconducting magnetic resonance industry is seriously controlled by people, so it is difficult to produce on a large scale and to support a wide range of clinical installation demand. The realization of self-controllable liquid-free helium industry chain can completely get rid of the dependence on helium resources and narrow the gap of per capita MR and hospital equipment between China and developed countries.