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

Hello, this is the customs specialist attorney.

If you wish to import medical devices from abroad, under the Medical Device Act, you must submit a standard customs clearance pre-report to the Korea Medical Device Industry Association.

This is a procedure that must be followed by default when importing medical devices. Also, medical device importing can only be done by those who have obtained import permission under the relevant law.

In this case, the name of the import permit holder and the importer name on the customs import declaration must match, and otherwise, customs clearance will not be permitted.

In other words, merely listing a name as a formality is not allowed.

However, in the case of medical devices for personal use as described below, customs clearance may be conducted with a requirement exemption confirmation under certain conditions.

For example, cases include continuing to use a medical device used during overseas residence after returning to Korea, cases where the device is not approved domestically and there is no alternative product, or cases needed for emergency patient treatment.

In these cases, customs clearance is possible only by submitting together a requirement exemption confirmation recommendation issued by the Korea Medical Devices Safety Information Institute or the Korea Medical Device Industry Association.

As such, importing medical devices has strict legal requirements, and the necessary documents and procedures may vary depending on the situation.

Therefore, to accurately understand and proceed with the relevant procedures in advance, it is safe to receive assistance from a customs specialist attorney well-versed in customs and import regulations.