[KCS FAQ] Medical Device Import Procedures and Requirements for Matching Licensees and Importers Released

1. Standard Import Notification Procedures

Pursuant to the Medical Devices Act, all importers must submit and complete a Standard Electronic Document for Import Notification through the Chairman of the Korea Medical Devices Industry Association (KMDIA) prior to customs clearance.

2. Matching Requirement Between Licensee and Importer

Following amendments to the Medical Devices Act, medical devices can only be imported under the name of the entity that holds the relevant import license. Since April 9, 2012, customs clearance is permitted only when the Licensee (the party authorized on the Standard Import Notification) matches the Importer listed on the customs declaration form.

Valid Customs Declaration Examples:

• Case 1: The 'Importer' on the declaration is the Licensee, while the 'Tax Obligor' (Payer) is a non-licensee.
• Case 2: Both the 'Importer' and the 'Tax Obligor' are the Licensee.

3. Exemptions for Personal Use and Special Circumstances

In accordance with Article 3 of the Regulations on the Exemption of Medical Device Import Requirements, certain devices may be cleared by obtaining a recommendation letter for requirement exemption from the National Institute of Medical Device Safety Information (NIDS) or the KMDIA:

• Devices used by an individual while residing abroad and brought into Korea for continued personal use.
• Foreign-licensed medical devices that are not yet approved or certified in Korea and have no domestic substitute.
• Medical devices required for the treatment of emergency patients as defined under the Emergency Medical Service Act.

4. Important Note

For specific determinations on whether a product qualifies as a medical device, importer eligibility, and detailed administrative procedures, please contact the Korea Medical Devices Industry Association (KMDIA) at 02-596-7404 or the National Institute of Medical Device Safety Information (NIDS).