MFDS guidance for importing unregistered medical devices
Sarah Baik

Sarah Baik

Principal Consultant, Korea



Korea’s Ministry of Food and Drug Safety (MFDS) has 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 types of medical devices that are eligible for the process, including better definitions of research-purpose only devices.
  2. Labeling guidance for products that are sterile, for research purposes and/or testing;
  3. Eased requirements for obtaining approval for the import of a non-registered medical device for personal use.
  4. Additional requirements when applying for an exemption, including providing a plan for use, the expiration date, disposal plan and information regarding the post-usage treatment;
  5. Additional guidance and documents for when making adjustments on how the product is used;
  6. 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. This includes application procedures, reporting plans and requirements, a 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, an explanation for why the product is urgently needed or scarce, plans/contracts for supplying the product(s) and product information.

That 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 decreases significantly. 

In conclusion, should you have questions or require support importing a 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.