According to AD HOC NEWS, South Korea's Ministry of Food and Drug Safety (MFDS) has announced an expansion of its performance certification system for digital health support devices. The initiative was presented at KIMES BUSAN 2026 and is intended to strengthen consumer trust in digital applications and health apps.
Voluntary, not equivalent to approval
According to the report, this is a voluntary performance certification. It is expressly to be distinguished from the conventional approval as a medical device. Companies take part on their own responsibility in order to have the performance of their solutions independently verified. The target group, according to the source, are products designated by the MFDS leadership, such as heart rate monitors for sport and leisure. After the corresponding legal basis took effect, specific performance criteria were developed for this purpose.
Advice at the trade fair
To establish the system, the MFDS is promoting it together with the Korea Information and Communication Technology Association (TTA) and the Korea AI Medical Healthcare Research Institute. The presentation takes place at the 14th Busan International Medical Device Exhibition from October 23 to 25 at Bexco in Busan. The participating institutions offer advice at booths B200 and B206, particularly for small and medium-sized enterprises and start-ups. A specialist seminar is also scheduled.
What this could mean for you
For developers of digital health applications, such a voluntary procedure could be a means of demonstrating performance. Whether and to what extent this gains significance in other markets is left open by the available information. The source names reliability explicitly as a growth factor but does not document any effects on international standards.
Sources
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