I Want to Import a Home Hemodialysis Machine Manufactured by a Foreign Manufacturer for Personal Use and Currently Distributed Overseas. Is It Possible? Released

Conditions for Exemption of Importation of Self-Use Medical Devices

• Legal Basis: Article 32 of the Enforcement Rule of the Medical Devices Act and Article 3, Item 10 of the Regulation on Exemption from Import Requirements for Medical Devices
• Exemption Targets: Self-use medical devices that meet the following conditions are exempt from import approval, certification, notification, and import requirement confirmation.
  • When intending to continue using a medical device used overseas after returning home
  • Overseas approved medical devices with no approved or certified substitute products in Korea
  • Medical devices for emergency patient treatment under the Emergency Medical Services Act

If the blood dialysis machine from the overseas manufacturer you intend to purchase has no approved/certified substitute product in Korea, the importation of the self-use purpose blood dialysis machine from the overseas manufacturer may be recommended for exemption based on this condition.

However, since a blood dialysis machine is a medical device that can have an immediate impact on human life, if there is a product approved/certified by the Ministry of Food and Drug Safety, it would be safer to purchase the certified product distributed domestically rather than a product not reviewed by the Ministry.

We recommend that you thoroughly check if there is a dialysis machine certified by the Ministry of Food and Drug Safety in Korea before making a purchase.  

Import Procedures

• If a self-use medical device qualifies for import requirement exemption, follow these procedures.
  • Prepare an application for recommendation for exemption confirmation according to Article 7 of the Regulation on Exemption from Import Requirements for Medical Devices.
  • Submit the following documents to the exemption confirmation agency (Korea Medical Device Safety Information Center) to receive a recommendation.
    • Import recommendation diagnosis or opinion
    • Product information (shape, performance, purpose, etc.)
    • Usage plan
    • Overseas approval-related materials

Key Summary

• When an individual imports a medical device for self-use, import-related regulations may be exempt under certain conditions.
• Check if the medical device intended for import qualifies for exemption and prepare the necessary documents to submit to the Korea Medical Device Safety Information Center.