Medical Device Registration.

We help determine whether a product is a medical device under Korean legislation and identify the appropriate device category. Where necessary, we submit an enquiry to MFDS to clarify its status and avoid uncertainty during registration.

We support registration of Class 1–4 medical devices and IVDs in Korea. Our consultants draw on extensive experience with Korean requirements to prepare, review and submit technical documentation and respond to requests for additional information.

Our aim is to help clients obtain Korean medical device registration efficiently while meeting regulatory requirements and supporting a successful market launch.

We coordinate testing required for device registration with qualified laboratories, including tests under IEC 60601 and ISO 10993. We work closely with clients on laboratory selection, test planning, progress management, results review and report preparation.

Our consultants help anticipate testing issues and obtain the data needed to meet regulatory requirements. Where results fall short, we advise on follow-up actions and strategies for addressing the gaps.