Guidelines on Importing Home Hemodialysis Machines for Personal Use Released

Exemption Conditions for Personal Use Medical Devices

Under the Medical Device Act and relevant regulations regarding the exemption of import requirements, certain medical devices intended for personal use may be exempt from standard import permits, certifications, or reporting requirements if they meet specific criteria.

• Legal Basis: Article 32 of the Enforcement Rules of the Medical Device Act and Article 3, Item 10 of the Regulations on the Exemption of Medical Device Import Requirements.
• Eligibility for Exemption:
  • Medical devices previously used overseas that the individual intends to continue using after returning to Korea.
  • Medical devices approved overseas for which there is no equivalent alternative product approved or certified in Korea.
  • Medical devices intended for the treatment of emergency patients as defined under the Emergency Medical Service Act.

Expert Recommendations and Safety Considerations

If the specific home hemodialysis machine you wish to purchase from an overseas manufacturer has no certified alternative available in the domestic market, it may be eligible for an import exemption recommendation for personal use based on the aforementioned regulations.

However, since a hemodialysis machine is a critical medical device that directly impacts human life, it is strongly advised to prioritize products already certified and distributed within Korea. Products reviewed and approved by the Ministry of Food and Drug Safety (MFDS) ensure a higher level of safety compared to non-reviewed items. We highly recommend verifying the availability of MFDS-certified alternatives before proceeding with an overseas purchase.

Import Procedures

If the medical device qualifies for an exemption, the importer must follow these administrative steps:

• Prepare an application for the Exemption of Import Requirement Confirmation in accordance with Article 7 of the relevant regulations.
• Submit the following documents to the National Institute of Medical Device Safety Information (NIDS) to obtain the recommendation:
  • A medical certificate or physician's opinion for import recommendation.
  • Detailed product information (shape, performance, intended use, etc.).
  • A personal use plan.
  • Evidence of overseas regulatory approval/certification.

Key Summary

• Individuals may import medical devices for personal use without standard regulatory hurdles under specific conditions.
• Importers must verify if the device meets exemption criteria and submit the required documentation to NIDS for formal approval before importation.