[Korea Customs Service FAQ] What procedures are involved in importing medical devices, and must the import licensee under the Medical Device Act and the importer on the import declaration be identical? Released

When importing medical devices, a standard import clearance pre-report must be submitted to the President of the Korea Medical Device Industry Association(www.kmdia.or.kr 02-596-7404) in accordance with the 「Medical Device Act」.

Due to the revision of the Medical Device Act, medical devices can only be imported in the name of the import permit holder. Therefore, from April 9, 2012, for import declarations, customs clearance is permitted only when the import permit holder under the Medical Device Act(the person who received the import permit on the standard import clearance pre-report) matches the name in the ’Importer’ field on the customs import declaration form.
* Examples of Customs Import Declarations : ① cases where the importer on the import declaration form is the import permit holder and the taxpayer does not have an import permit, or ② cases where both the importer and the taxpayer are import permit holders

However, in the case of medical devices for personal use as listed below, in accordance with “Article 3 of the Regulations on Exemption from Confirmation of Medical Device Import Requirements, etc.”, customs clearance is possible with a recommendation letter for exemption from medical device requirements from the head of the Korea Medical Device Safety Information Service or the president of the Korea Medical Device Industry Association.
A. Medical devices used while staying abroad and intended for continued use after returning to Korea
B. Medical devices that are not licensed or certified in Korea and for which there are no alternative products(foreign licensed products)
C. Medical devices used for the treatment of emergency patients as defined in Article 2, Paragraph 1 of the 「Emergency Medical Service Act」
※ Please inquire with the relevant aforementioned institutions regarding whether it qualifies as a medical device, the importer's qualifications, detailed procedures, etc.