The Ministry of Food and Drug Safety revised the “Innovative Medical Devices Priority Review Guidelines (Guide for Applicants)” on September 6, 2024. These revisions simplify the legislation related to priority reviews for innovative medical devices and update the organizational structure to align with current practices. This updated guideline is essential for medical devices that provide significant advancements in healthcare, ensuring they can undergo a faster review process and reach the market more quickly.
For businesses in the medical device sector, the new guidelines represent an opportunity to expedite market access for groundbreaking products. Understanding the updated criteria and processes is critical for companies looking to bring innovative medical devices to market swiftly. Products that offer substantial improvements in healthcare outcomes are now better positioned for a streamlined review.
Please contact RegAsk to help navigate the updated guidelines and expedite market access for your innovative medical devices.
