Medical Device Import License
Medical device importing requires both an import business license under Article 15 of the Medical Devices Act and a per-item import approval, certification or notification. Devices are sorted into four risk classes, each handled by a different authority, and licenses carry a five-year validity that must be renewed.
How We Handle It
Classification
Confirm the product is a medical device and determine its class, which decides whether approval, certification or notification applies.
Facilities & QMS
Put the required testing facilities and quality management system in place; testing may be outsourced to an accredited laboratory.
Quality Manager
Appoint a quality manager responsible for import, quality and safety control, with proof of qualification and ongoing training.
Business Licence Filing
Submit Form 1 to the Regional MFDS office together with at least one item approval, certification or notification.
Item Licensing
File technical documentation and manufacturing-site QMS evidence with MFDS (approval) or the Korea Medical Device Safety Information Institute (certification/notification).
Post-Licence Duties
Maintain labelling compliance, adverse event reporting, import volume reporting and renewal before the five-year expiry.
Frequently Asked Questions
Q. How are medical devices classified?
A. Into four classes by potential risk to the human body: Class 1 (negligible), Class 2 (low), Class 3 (moderate) and Class 4 (high). The criteria consider duration of body contact, degree of invasiveness, and whether a drug or energy is delivered to the patient (Medical Devices Act Art. 3(2), Enforcement Rule Art. 2, Annex 1).
Q. How does an import business license differ from a product license?
A. You need both. The import business license is the operating permit for the company (Art. 15(1)). The per-item import approval, certification or notification covers each product (Art. 15(2)). Article 15(3) requires at least one item approval or certification to be filed together with the business licence application.
Q. Which authority do I apply to?
A. The import business license goes to the head of the Regional Ministry of Food and Drug Safety office covering your import premises. Item-level import approval goes to the Minister of Food and Drug Safety, while certification and notification go to the Korea Medical Device Safety Information Institute.
Q. Which route applies to which class?
A. As a rule Class 3 and 4 require approval, Class 2 requires certification, and Class 1 requires notification. A Class 2 device still needs full approval if it is not substantially equivalent in structure, principle, performance, intended use or method of use to an already approved, certified or notified device.
Q. How long does it take?
A. The authority must notify its decision on the import business license within 25 days of application. If no decision or extension notice is given within that period, the license is deemed granted on the day after it expires (Art. 6(8)-(9), applied to imports by Art. 15(6)). Item-level licensing can take several months depending on class and document review.
Q. Does the license expire?
A. Yes. Import approval, certification and notification are valid for five years from the date granted or accepted (Art. 49(1)). Renewal must be obtained before expiry, and a device that was never imported during the validity period generally cannot be renewed.