Enforcement Rule of the Medical Devices Act
The enforcement rule detailing implementation requirements under the Medical Devices Act in South Korea. This establishes operational procedures and regulatory requirements for medical device approval, notification, and post-market oversight.
Manufacturers and sponsors placing medical devices on the South Korea market should review their current compliance documentation against this change. Assess whether your device class, labelling, registration status, or technical documentation is affected. Where gaps are identified, update your files and notify your local representative or importer. Refer to the official source below for the full regulatory text and any transitional arrangements.
View official source ↗