[Korea Customs FAQ] Import Procedures for Medical Devices and Consistency Requirements for Importers Released

Standard Customs Clearance Notification Requirement

Pursuant to the Medical Device Act, all importers of medical devices must file a Standard Customs Clearance Notification with the Chairperson of the Korea Medical Devices Industry Association (KMDIA) (www.kmdia.or.kr) prior to the arrival of the goods.

Mandatory Matching of Importer and License Holder

Due to amendments in medical device regulations, medical devices may 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 Importer listed on the Customs Import Declaration is identical to the Import License Holder (the party authorized on the Standard Customs Clearance Notification).

• Case 1: The 'Importer' on the declaration is the license holder, even if the 'Taxpayer' is an entity without an import license.
• Case 2: Both the 'Importer' and the 'Taxpayer' are license holders.

Exemptions for Personal or Special Use

In accordance with Article 3 of the "Regulations on Exemption from Import Requirement Verification for Medical Devices," certain medical devices may be cleared through customs by obtaining a Recommendation for Exemption from the National Institute of Medical Device Safety Information (NIDS) or the KMDIA for the following cases:

• Medical devices used by an individual while residing abroad that are intended for continued personal use after returning to Korea.
• Medical devices that are neither licensed nor certified in Korea and have no domestic substitutes (foreign-certified products).
• Medical devices required for the treatment of emergency patients as defined under the Emergency Medical Service Act.

Consultation and Verification

To determine whether a specific item is classified as a medical device, or to verify importer qualifications and detailed procedural requirements, please contact the Korea Medical Devices Industry Association (KMDIA) or the National Institute of Medical Device Safety Information (NIDS) directly.