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June 2026South Korea has revised the Enforcement Rules of the Medical Devices Act (Decree No. 2127), updating regulatory requirements for the manufacture, approval, quality management, clinical evaluation, and post-market oversight of medical devices.
The revised rules introduce changes to technical document review agencies, conformity assessment procedures, and compliance requirements, while also updating enforcement timelines for selected provisions.
The regulation outlines requirements for medical device classification, manufacturing and import licenses, quality management systems (QMS), clinical trials, licensing exemptions, and technical documentation. It also strengthens provisions for post-market surveillance, product notifications, and regulatory reporting.
Additional updates cover application procedures, fee structures, and requirements for the sale and distribution of medical devices, helping manufacturers maintain compliance throughout the product lifecycle.
The amendments aim to improve regulatory efficiency, reinforce product quality and safety, and align South Korea’s medical device framework with evolving regulatory expectations.
Region: Korea, Republic of
Source: 의료기기법시행규칙
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