Seoul City to Crack Down on Uncertified 'Oxygen Saturation Monitors' Used Deceptively for Treatment

Intensive Crackdown in April on Advertising and Sales of COVID-19 Treatments
Only 10% of Products Sold on Major Online Shopping Malls Are Officially Certified Medical Devices

[Asia Economy Reporter Lim Cheol-young] The Seoul Metropolitan Government's Civil Life Judicial Police Unit announced on the 31st that it will conduct intensive crackdowns in April on the advertising and sale of "oxygen saturation monitors," which have seen a surge in demand due to the recent rapid increase in COVID-19 cases, without certification as medical devices.

An oxygen saturation monitor is a device that measures the amount of oxygen in the blood to indicate whether oxygen is being adequately supplied to the body. It is an essential medical device that allows high-risk COVID-19 patients undergoing home treatment to consult a doctor and respond to emergencies if their oxygen saturation level falls below 94.

Seoul City monitored the sales status of oxygen saturation monitors at five major online shopping malls in March and found that only about 10% of the top 10 best-selling products were certified medical devices by the Ministry of Food and Drug Safety (MFDS). The majority of the other products resembled medical devices in appearance but had not undergone official performance verification.

The targets of this crackdown include manufacturing, importing, and selling uncertified medical devices; advertising that may mislead consumers into thinking non-medical devices are medical devices; and false or exaggerated advertising. When importing or selling oxygen saturation monitors for medical purposes, MFDS medical device import certification must be obtained. Avoiding this by importing them as industrial products and selling them without Korean labeling constitutes uncertified medical devices and violates the Medical Device Act.

Cases where uncertified products are sold with labels stating "This product is not a medical device," but the main advertising content includes phrases like "Silent hypoxia of COVID-19" and "Prevent emergencies in advance with oxygen saturation monitors," misleading COVID-19 patients to use them, are also subject to crackdown. Additionally, advertising that deceives consumers with false or exaggerated claims will be punished under the Medical Device Act.

Previously, the Seoul Civil Life Judicial Police Unit conducted intensive crackdowns on illegal products such as masks, hand sanitizers, and thermometers, which are major quarantine supplies, from 2020 to 2021, resulting in 44 criminal charges. This year, they continue to monitor the distribution of COVID-19-related quarantine supplies. To prevent citizens from suffering harm due to unverified oxygen saturation monitors, when purchasing COVID-19-related products, citizens are advised to check for ▲the Korean label "medical device" ▲the "certification number-model name" label, and if suspicious, verify certification on the "Medical Device Electronic Civil Service Window" website before purchase.

Seoul City accepts reports of illegal medical devices through various channels such as smartphone apps, the Seoul City website, phone calls, visits, and mail. If citizens contribute to public interest by reporting criminal acts with decisive evidence, they may receive rewards up to 200 million KRW according to the Seoul Metropolitan Government Ordinance on Protection and Support for Public Interest Whistleblowers.

Kang Ok-hyun, head of the Seoul Civil Life Judicial Police Unit, explained, "At a time when many citizens have heightened interest in health due to COVID-19, we will strengthen monitoring to ensure that citizens' health is not threatened by unsuitable quarantine products and will conduct strict investigations upon discovering illegal activities."

Certification Advertising Unrelated to Medical Devices, KC Certification

This content was produced with the assistance of AI translation services.