Other Regulatory Changes The KFDA also introduced a new expedited review process for medical device

Other Regulatory Changes
The KFDA also introduced a new expedited review process for medical device registration. Devices utilizing novel technology and orphan devices now are eligible to apply for expedited review. The KFDA will conduct consultation meetings with manufacturers of medical devices approved for expedited review, and offer more streamlined guidance in terms of product registration.

In addition, the new Medical Device Act listed new restrictions on medical devices going through the registration process. Incomplete applications no longer will be considered. Unlike prior cases, the KFDA no longer will issue notices requesting additional information if the application is incomplete. Additionally, medical devices for which the product license has been revoked within one year will not be approved. Another restriction is that medical devices with misleading or inaccurate brands and names will not be approved.

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The new KFDA regulations will improve transparency and predictability for medical device registration requirements in Korea, despite the fact that they are more stringent for risky medical devices. Implementation of the new regulatory changes will enable the Korean population to access safer and higher-quality medical devices. The KFDA’s broader data acceptability also will increase the ease of entering the Korean market for Western medical companies.