Importation of medical appliances

3/4/2022 5:11:17 AM

In accordance with the Medical Devices Act, an importer shall fulfill reporting a criteria customs prediction report to the chairman of the Korea Medical Devices Industry Association or to the chairman of the Korean Dental Industry Association. For goods that are both medical appliances as well as electrical appliances like electrically operated massagers and etc., therefore falling under other legislations, then these goods shall also fulfill the import requirements as prescribed by the relevant legislation, such as the Electrical Appliances Safety Control Act.

On whether the imported goods are subject to medical appliances, the qualification of an importer, and detailed procedures, please contact the relevant institutions.

Ministry of Food and Drug Safety General Consultation Center
- 1577-1255
- www.mfds.go.kr

Korea Medical Devices Industry Association
- 02-596-7404
- www.kmda.or.kr

Korean Dental Industry Association
- 02-754-5921
- www.kmda.or.kr

Korean Agency for Technology and Criteria
- 1544-7115
- www.kats.go.kr


Recommendation of medicine and medical appliances for exemption from import qualifications

When importing medical appliances (less than two thousand US dollars) for the purpose of self-treatment and etc., in accordance with [Recommendation Guidance of Medicine and Medical Supplies among Objects subject to Exemption from Verification of Import Qualifications] (Notice from the Ministry of Food and Drug Safety), when a patient receives a recommendation from the competent mayor/Do governor having jurisdiction over the hospital he/she is being treated and submits it to the head of a customs office, then an exemption from verification of import qualifications can be granted to the person.

At this point, obtain a written diagnosis for import recommendation issued by the director of a national/public hospital, the head of a health center, or the director of a medical institution designated by the Medical Service Act, and consult the relevant division of a mayor/Do governor