DNV signs MOU with Korea Medical Devices Association to support regulatory readiness of medical device manufacturers

DNV has signed a Memorandum of Understanding (MOU) with the Korea Medical Devices Association (KMDA) to support Korean medical device manufacturers in strengthening regulatory compliance capabilities and preparing for global market access.

The signing ceremony was held on 28 April in Seoul. Through this collaboration, both organizations aim to support Korean medical device manufacturers in navigating evolving global regulatory requirements, particularly under the European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Under the agreement, DNV and KMDA will collaborate on joint seminars and training programmes, as well as knowledge-sharing initiatives related to medical device regulations and quality management systems.

With the implementation of the EU MDR and IVDR, medical device manufacturers are facing increasingly stringent regulatory expectations across areas such as clinical evaluation, post-market surveillance, risk management, software validation, and quality management system operations. As a result, the importance of practical regulatory understanding and certification readiness continues to grow across the industry.

Cecilie Gudesen Torp, Global Director for Medical Services and Managing Director of DNV Product Assurance AS, said: “The global medical device regulatory landscape continues to evolve, requiring manufacturers to demonstrate increasingly robust regulatory compliance capabilities. Through this collaboration with KMDA, we look forward to supporting Korean manufacturers with training, regulatory insight, and certification expertise to help them navigate global market requirements more effectively.”