[Healthcare] Review of legal matters regarding whether medical devices and wellness products fall under healthcare.

Law firm Veat undertook legal review on behalf of healthcare platform A regarding whether the healthcare platform constitutes a medical device.

A provides services through its platform using an AI system that learns medical big data based on user’s health information. Therefore, A inquired to Law firm Veat regarding whether the customer’s platform, which provides healthcare services, constitutes a medical device.

Law firm Veat comprehensively examined the possibility that A’s platform-provided healthcare services fall under the definition of a “medical device” as stipulated in the ‘Medical Device Act,’ and, according to relevant agency guidelines, products that aim to maintain or improve general health conditions, without the purpose of diagnosing or treating diseases or medical conditions, are considered medical devices.

Furthermore, Law firm Veat provided legal review guidance regarding inquiries about whether the customer’s services fall under the category of wellness products, such as those mentioned in the guidance of the Ministry of Food and Drug Safety as examples of general wellness products.

Generally, wellness products are defined as products that simply present analytical results based on specific numerical values or transmit, output, or analyze health data for general health management purposes.

With the development of technologies such as IoT and artificial intelligence, various products combining these latest technologies with medical devices and health aids are being developed and launched. Careful examination is necessary to ensure compliance with relevant regulations such as the ‘Medical Device Act’ and procedures.

Law firm Veat is staffed with engineers and lawyers who simultaneously understand ‘digital, IT/technology’ and ‘law’, providing comprehensive legal consulting for digital healthcare and wellness fields.

If you need legal advice regarding whether the technology being developed or conducted falls under the category or in order to grow as a healthcare company, please contact Law firm Veat. A digital healthcare lawyer from Law firm Veat will assist you.

Thank you.

Law firm Veat