Wandong Medical Technology Co., Ltd, a prominent player in medical imaging, has achieved the coveted Medical Device Regulation (MDR) certification for seven major product series. This success follows the recent certification for superconducting magnetic resonance, showcasing Wandong’s commitment to global standards.
In a strategic move, Wandong has transitioned its X-ray, CT, and MRI products from CE Medical Devices Directive (MDD) to the more rigorous CE MDR. This aligns with the stringent requirements of the Medical Device (MDR) Regulation (EU) 2017/745, effective since May 2017.
MDR certification is essential for European market entry, ensuring compliance with comprehensive standards. Wandong’s completion of this cycle reflects its dedication to meeting the challenging pre-market certification review with heightened stringency and an extended cycle.
Wandong Medical, with nearly 70 years of industry expertise, is a key player in medical imaging. Beyond its extensive Chinese network, the company exports to over 70 countries. Wandong’s MRI systems and major X-ray equipment hold ISO/CE/FDA clearance, underlining its commitment to global regulatory standards.
MDR certification acts as a catalyst for Wandong Medical’s accelerated international expansion, in line with its strategy of providing Chinese healthcare solutions globally.