Non-contact body temperature measuring device (Source: Patron website)

He stated, “The market for disease prediction, such as Watson’s genomics and Illumina’s genomic analysis, will grow the most,” adding, “The usability of mobile medical devices is low in the domestic market.” "Fear and regulations stemming from a lack of experience in utilizing mobile medical devices and data are the problem," they said, predicting that the market for medical device utilization will only grow once there is experience.

Park Ho-jun, Director of the KTL Medical Device Research Center, stated, “The scope of medical devices referred to in Article 2 of the Medical Devices Act is broad, so smart healthcare devices are often included,” adding that “the purpose of use is important.”

"Medical devices" as defined in the Medical Devices Act are instruments, machines, devices, materials, or similar products used on humans or animals. Products used for the purpose of diagnosing, treating, alleviating, managing, or preventing diseases; products used for the purpose of diagnosing, treating, alleviating, or correcting injuries or disabilities; products used for the purpose of examining, replacing, or modifying structures or functions; and products used for the purpose of controlling pregnancy are all classified as medical devices.

In other words, since all products for the diagnosis and prevention of disease are included, there is a high likelihood that they will be classified as medical devices unless they are fitness products. This means that the classification criteria vary depending on the intended use.

Body data can be obtained using smartwatches or smartbands (Source: IBM website)

For example, in Europe, oxygen saturation measuring devices used to check for the use of oxygen tanks during climbing are not classified as medical devices. However, in Korea, there was controversy over whether attaching an oxygen saturation device to the Galaxy Note 4 constitutes a medical device. The Ministry of Food and Drug Safety interpreted non-medical pulse oximeters as being for leisure purposes and did not classify them as medical devices.

Director Park stated, “While efficacy, economic efficiency, and safety are important for medical devices, safety is paramount for electronic medical devices,” adding, “To export medical devices overseas, there are many standards to adhere to, including management, medical device safety, and clinical trials.”

He noted the difficulty in complying with risk management standards among the many criteria, stating, “In the past, passing was granted if the deliverables met the standards, but with the revision of IEC 60601 to the 3rd edition, the number of items has increased from 379 to over 1,260.” He added, “In addition to this, manufacturers must add requirements if they deem something risky. Since the evaluation focuses on documenting the process rather than the results, it has become difficult to meet the regulations.” He explained that it is important to check standards related to how medical devices are classified, their scope of application, and their purpose.