The Medical Device (의료기기) industry in Korea is strictly regulated, and relevant businesses must obtain the appropriate license. Below is a concise explanation of what it covers and who needs it.
What is a medical device?
Under Korean law, a medical device is any product used on humans or animals for diagnosing, treating, managing, or preventing disease; correcting injuries; modifying bodily functions; or controlling pregnancy. Medicines, quasi-drugs, prosthetics, and assistive devices are excluded.
Which businesses require a medical device license?
Businesses that manufacture or import medical devices must obtain a license from the Ministry of Food and Drug Safety (MFDS). This requirement also extends to operators engaging with medical devices as part of their business activities, including sellers, lessors, and repairers.
Although Class 1 and Class 2 devices typically undergo certification or notification rather than approval, some devices in these classes still require approval—such as products not equivalent to an already approved/certified/notified device, or those in specially regulated higher-risk categories. Class 3 and Class 4 devices, due to higher risk, are always subject to approval.
What does the medical device license indicate about the business?
A medical device manufacturing or import license confirms that a company is officially authorized to manufacture or import medical devices in Korea and has met MFDS requirements for facilities, quality management systems, safety controls, and regulatory compliance.
Coverage in KOBDi: The KOBDi database includes businesses registered with Medical Device (의료기기) licenses. This information appears on each Business Profile page, and companies with this license can be found via the KOBDi Korea Industry Search.