Is it possible to import a home hemodialysis machine manufactured by an overseas manufacturer and currently distributed abroad for personal use? Released

Conditions for Exemption of Import of Medical Devices for Personal Use

• Legal Basis: Article 32 of the 「Enforcement Rule of the Medical Devices Act」 and Article 3, Paragraph 10 of the 「Regulations on the Exemption of Confirmation of Import Requirements for Medical Devices, etc.」
• Exemption Eligibility: Medical devices for personal use that meet the following conditions are exempt from import permits, certifications, notifications, and confirmation of import requirements.
  • Cases where a medical device used overseas is intended to be used continuously after returning to Korea
  • Overseas-authorized medical devices for which there is no alternative product authorized or certified in Korea
  • Medical devices for the treatment of emergency patients under the 「Emergency Medical Service Act」

If the hemodialyzer from the overseas manufacturer you wish to purchase has no alternative product authorized/certified in Korea, you may be eligible for an exemption recommendation for the import of that manufacturer's product for personal use based on these conditions.

However, since a hemodialyzer is a medical device that can have an immediate impact on human life, if there is a product authorized/certified through a rigorous review by the Ministry of Food and Drug Safety (MFDS), it would be safer to purchase that certified product currently distributed in Korea rather than an item that has not undergone MFDS review.

We strongly recommend checking whether there is a dialyzer certified by the MFDS in Korea before proceeding with your purchase.  

Import Procedure

• If the medical device for personal use is eligible for exemption from import requirements, follow these procedures:
  • Complete an application for a recommendation for exemption from requirement confirmation in accordance with Article 7 of the 「Regulations on the Exemption of Confirmation of Import Requirements for Medical Devices, etc.」
  • Submit the following documents to the requirement exemption confirmation body (National Institute of Medical Device Safety Information) to receive a recommendation:
    • Medical certificate or physician's opinion for import recommendation
    • Product information (shape, performance, purpose, etc.)
    • Plan of use
    • Materials related to overseas authorization

Key Summary

• When an individual imports a medical device for personal use, import regulations may be exempt under specific conditions.
• You must verify whether the medical device you wish to import qualifies for exemption, prepare the required documents, and submit them to the National Institute of Medical Device Safety Information.