[Customs FAQ] What is the procedure for importing medical devices, and must the importer under the Medical Device Act and the importer on the import declaration form be the same? Released

When importing medical devices, a standard customs clearance report must be submitted to the President of the Korea Medical Devices 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 under the name of the import license holder. Therefore, from April 9, 2012, customs clearance is allowed only when the name of the import license holder under the Medical Device Act(the person who received the import license on the standard customs clearance report) matches the name of the 'importer' on the customs import declaration form.
* Customs import declaration cases: when ① the importer on the import declaration form is the import license holder and the taxpayer is not the import license holder, ② or both the importer and the taxpayer are the import license holders

However, in the case of the following self-use medical devices, customs clearance can be obtained by preparing a recommendation letter for exemption confirmation of medical device requirements from the President of the Korea Medical Device Safety Information Institute or the President of the Korea Medical Devices Industry Association in accordance with Article 3 of the Regulation on Exemption from Confirmation of Medical Device Import Requirements, etc..
A. Medical devices that were used while staying abroad and are intended to be used continuously after returning home
B. Medical devices that are not approved or certified in Korea and have no substitute products(foreign approved products)
C. Medical devices used for the treatment of emergency patients as defined in Article 2, Paragraph 1 of the Emergency Medical Services Act
※ Please contact the relevant institutions for inquiries regarding whether it is a medical device, the qualifications of the importer, detailed procedures, etc..