TFDA Announces Amendments to "Reference Guidelines for Classification of Medical Software"
 

The TFDA published the "Reference Guidelines for Classification of Medical Software" in  2015 years, but with the prevalence of wearable devices, revised guidelines were announced this month.

Manufacturers can follow the guidelines to determine the attributes of the relevant products, such as heart rate, blood oxygen function if not claimed medical functions, but only to provide personal independent health management, you do not need to apply for a license.

However, if the monitoring data is to be provided to hospitals for clinical diagnosis and treatment, it is still considered a medical device, and manufacturers can apply for services through the medical device attribute management inquiry or write to the Food and Drug Administration.

In addition, whether the management attribute of a health promotion product is a medical device depends on factors such as the risk of the product.

Besides, whether the product is invasive, implantable, or causing injury or disease to users and other potential risk factors, and its management attributes are evaluated in a comprehensive manner.

reference:https://www.fda.gov.tw/TC/newsContent.aspx?cid=3&id=26636
https://tw.appledaily.com/life/20201224/CPHK3S44GNH4RCNPZJVL45NOIE/