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Classification of Medical devices in Korea

The Korean Medical Device Law classifies medical devices into four categories (ⅰ, ⅱ, ⅲ and ⅳ).

Class ⅰ : medical devices with little potential danger;

Class ⅱ : medical devices with low potential danger;

Class iii: medical devices with moderate potential danger;

Class ⅳ : high-risk medical devices. Classification of medical devices based on: degree of risk, contact area and contact time with human body, product safety and effectiveness.

Korean medical device technical document type

Technical documents contain information on medical device design, materials, uses, manufacturing methods, etc. The Korean technical document is similar to the European technical document or the U.S. FDA 510(K) submission. Level II and above equipment will need to submit test information and technical documentation, and most products will require additional performance testing to meet Korean requirements. In addition to the standard application, a brief technical document (STED) is required for Class IV equipment.

Classification of Medical devices in Korea

Korean medical device technical document type

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