Customs attorney, what procedures must be followed when importing medical devices?

Hello. I am a customs attorney.

When importing medical devices from abroad, you must submit a standard customs clearance report to the Korea Medical Devices Industry Association in accordance with the Medical Devices Act.

This is a procedure that must basically be followed when importing medical devices. In addition, the import of medical devices can be carried out only by a person who has obtained an import license under the relevant statute.

At this time, the name of the import license holder and the name of the importer on the customs import declaration must match, otherwise customs clearance is not permitted.

In other words, a method of merely listing a name as a formality is not possible.

However, in the case of medical devices for personal use as described below, customs clearance is possible by obtaining a requirement exemption confirmation under certain conditions.

For example, this applies to cases such as where a person intends to continue using a medical device that was used while staying abroad after returning home, where the device is not licensed domestically and there is no substitute product, or where it is needed for the treatment of an emergency patient.

In this case, customs clearance is possible only when a requirement exemption confirmation recommendation issued by the Korea Institute of Medical Device Safety Information or the Korea Medical Devices Industry Association is submitted together.

As such, the import of medical devices has demanding requirements under the statutes, and the necessary documents or procedures may vary depending on the situation.

Therefore, in order to accurately understand and carry out the relevant procedures in advance, it is safer to obtain the assistance of a customs attorney who is well versed in customs and import regulations.