As per Notice from MFDS:
The Heart Rate Monitor and Pulse Monitor that are used for exercise and leisure purpose need not be included in the product classification for the medical purpose.
In defining the Heart Rate Monitor and Pulse Monitor, those that are designed for exercise and leisure will be excluded (Appendix A26080.01, A26080.02).
Recently, Heart Rate Monitor and Pulse Monitor are continually incorporated into devices such as smart phones, and these Heart Rate Monitor and Pulse Monitor incorporated into smart phones are mostly not used directly for medical diagnosis of illness, but are used for exercise and leisure purpose. Nonetheless, there are confusions regarding classification and designation of these devices into the medical device classification, thus requiring them to be licensed in accordance with the Medical Device Act.
Henceforth, the products used for exercise and leisure are to be excluded from the medical device classification for the product classification purpose of Heart Rate Monitor (A26080.01) and Pulse Monitor (A26080.02), and those exercise and leisure products shall be required to obtain the license as medical devices only when they change the marketing purpose to include the medical use.
Furthermore, those who received manufacturing/importing license of Heart Rate/Pulse Monitor as exercise/leisure purpose shall receive the license to change from Minister of Food and Drug Safety of the regional office within 6 months in order to change the said purpose to the medical purpose.
By excluding Heart Rate Monitor and Pulse Monitor for the exercise/leisure purpose from the designation of the medical device product classification, it Is possible for a reasonable regulatory operation to be efficiently administered, and for the international harmonization to be promoted; subsequently, there is a practical benefit to classify/maintain these devices as the medical purpose and the exercise purpose.
See the original notice here.
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