Korea Medical Device Certification: Faster Process for Class II Medical Devices
On September 14, 2026, the Ministry of Food and Drug Safety (MFDS) announced a proposed partial amendment to the Enforcement Rule of the Medical Devices Act to establish a one-stop procedure that links certification with technical document review, with the aim of supporting faster market entry for Class II medical devices with relatively low potential risks. Public comments on the proposed amendment will be accepted until October 26, 2026. Previously, to obtain certification for a Class II medical device, applicants had to follow a two-step sequential process: first, complete the technical document review by a designated technical document review institution, and then apply for certification to the National Institute of Medical Device Safety Information (NIDS) by submitting the review report. Once the proposed amendment takes effect, companies will be able to apply to NIDS for Class II medical device certification and technical document review at the same time. As a result, the t...