Renewing a medical device manufacturing license in South Korea is critical for ensuring the safety and efficacy of medical devices in the market. The renewal process can be complex and time-consuming. This guide provides tips to any company seeking to renew their medical device license, including criteria for renewal, how to fill in a medical device license application, common mistakes to avoid, and the consequences of non-renewal.

The operation manual is the most official and comprehensive reference to the operation and maintenance of a product or a device. Manuals provide conceptual information, such as design theory. An operating manual must contain all relevant information, features, procedures, and tasks to install, update, maintain and remove the product or software. It should also describe the main tasks and solutions to typical problems or questions in detail for the user.