MFDS Establishes 17 New Categories to Expedite Productization of Autonomous Wheelchairs

The Ministry of Food and Drug Safety announced on the 1st that it has established 17 new product classifications for electric wheelchairs equipped with autonomous driving functions and prepared the "Guidelines for Performance Evaluation of Autonomous Electric Wheelchairs" for safety and efficacy assessment during approval and licensing.

This initiative aims to expedite the commercialization of advanced technology products developed to enable people with mobility difficulties such as persons with disabilities, patients, and the elderly to move more safely and conveniently than conventional wheelchairs. Autonomous electric wheelchairs are medical devices integrating technologies such as LiDAR, G.P.S, artificial intelligence (AI), and voice sensors, enabling functions like location determination, map creation, route planning, obstacle recognition, and automatic braking.

An official from the Ministry of Food and Drug Safety explained, "The establishment of these new product classifications and guidelines is the result of Director Oh Yu-kyung’s visit to the Korea Workers' Compensation & Welfare Service Rehabilitation Engineering Research Institute last April to explore policy and administrative support measures necessary for the development of digital-based innovative products, where she personally experienced the autonomous electric wheelchair under development and promptly fulfilled the government's commitment to actively support product commercialization."

To facilitate the rapid market entry of autonomous electric wheelchairs, a consultative body comprising developers of autonomous electric wheelchairs, testing institutions, and related academic experts was formed in May, followed by the selection of this initiative as Task 33 under the "Regulatory Innovation 2.0 for Food and Drug" in June.

The Ministry of Food and Drug Safety will first designate and announce the 17 newly established product classifications related to autonomous electric wheelchairs as "customized rapid classification items" and plans to formally designate them as new product categories by revising related regulations by December.

The guidelines for performance evaluation of autonomous electric wheelchairs include assessment items to ensure safety and performance such as ▲success rate of reaching the destination ▲maintenance of safe distance on the driving route ▲avoidance performance of dynamic and static obstacles ▲emergency and protective stop functions ▲occupant departure warning function.

Jang Yoo-jin, a secretary at the Korea Federation of Organizations of the Disabled, said, "We welcome the preparation of a temporary product classification plan for autonomous electric wheelchairs in anticipation of future industries," adding, "We hope that innovative technology will lead to the development and commercialization of safe and effective autonomous electric wheelchairs, bringing tremendous convenience and innovation to the lives of persons with disabilities in the future."

Director Oh Yu-kyung of the Ministry of Food and Drug Safety stated, "We will continue to monitor whether new technology-based medical devices that can improve the quality of life for the public face difficulties entering the market due to regulations, and we will establish a foundation for the growth of related industries through bold improvements and support."

This content was produced with the assistance of AI translation services.