MFDS guidance for importing unregistered medical devices
Sarah Baik

Sarah Baik

Principal Consultant, Korea



Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products. After a brief review and public consultation period, the revisions officially went into effect on January 17, 2020. 

The primary updates found in MFDS Notice No. 2020-4 include:

  1. Additional clarification regarding the type of the medical devices that are eligible for this process, including better defining research-purpose only devices.
  2. Labeling guidance for products that are sterile, for research purposes and/or testing;
  3. Easing the requirements for obtaining an approval for importing a non-registered medical device for personal use.
  4. Additional requirements when applying for an exemption, including providing a plan for how it will be used, the expiration date, disposal plan and information regarding the post-usage treatment;
  5. Additional guidance and documents for adjusting how the product is being used;
    The requirements for a non-registered medical device imported into Korea for testing or exhibition purposes.
Scarce and/or Urgently Needed Devices

The second notice, MFDS Notice No. 2020-5, outlines the process for obtaining scarce and/or urgently needed devices which includes application procedures, reporting plan and requirements, schedule of demand surveys and the process for stockpiling. In general, the MFDS expects the requesting party to provide justification for why the product is needed from a qualified healthcare professional and other relevant administrative agencies, explanation for why the product is urgently needed or scarce, plans/contracts for supplying the product(s) and product information.

This being said, if the applicant can show that the needed device is identical to a medical device that has already been licensed, certified or declared, the required documentation needed for approval is significantly decreased. 

If you have questions or require support importing an qualifying un-registered medical device into Korea, Asia Actual has a strong regulatory team in Korea that can help you navigate the regulatory requirements. Contact Asia Actual if you have questions or require importing support.