Osong headquarters of the ##Ministery of Food and Drug Safety## /Courtesy of ##Ministery of Food and Drug Safety##

Specific criteria have been established to exempt rare-disease medical devices that have already been used overseas from the "post-market surveillance" that must be conducted in Korea for up to seven years.

The Ministery of Food and Drug Safety said on the 31st that it partially revised the "regulation on post-market surveillance of medical devices," detailing the exemption criteria for post-market surveillance of medical devices with overseas use experience and the submission materials required for applications.

Post-market surveillance is a system that confirms the safety and effectiveness of rare medical devices and newly developed medical devices for a certain period after they are sold in Korea. The Ministery of Food and Drug Safety commissioner sets the surveillance period within a range of at least four years and no more than seven years.

Previously, medical devices with overseas use experience could be exempted from post-market surveillance after review by the Medical Device Committee, but it was unclear what criteria would be used to recognize overseas use experience and what materials had to be submitted to prove it.

With this revision, the scope of medical devices with overseas use experience has been clarified, and the types and scope of materials to be submitted when applying for a post-market surveillance exemption have been set. Overseas clinical data and the like are included among the main submission materials.

Details such as submission materials for exemption from domestic post-marketing surveillance (draft Article 9)./Courtesy of ##Ministery of Food and Drug Safety##

Accordingly, medical device companies can apply for a post-market surveillance exemption by submitting materials that can prove overseas use experience. As the criteria for determining exemptions and the required materials have become clearer, predictability for related companies is also expected to improve.

This revision is a follow-up measure to the revised "enforcement rule of the Medical Devices Act" on Jul. 1. The enforcement rule allows medical devices with overseas use experience to be exempted from post-market surveillance after review by the Medical Device Committee.

A Ministery of Food and Drug Safety official said, "With this revision, we expect to reduce the industry's administrative burden and ensure the stable supply in Korea of rare medical devices whose safety and effectiveness have been secured," adding, "It will also help improve treatment access for patients with rare diseases."

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