Medical Device Good Manufacturing Practice (GMP) Regulations
Regulations establishing good manufacturing practice standards for medical device manufacturers in South Korea. This regulation sets mandatory quality management and manufacturing process requirements for medical device production.
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 ↗