Apple receives GMP compliance evaluation from MFDS for medical devices
Interpreted as preliminary work to add ECG function
Samsung obtains software medical device approval for mobile app
[Asia Economy Reporter Han Jinju] As Apple has begun the medical device approval process with the Korea Ministry of Food and Drug Safety (MFDS), the Apple Watch with the electrocardiogram (ECG) function activated is highly likely to be sold as a medical device in South Korea. Apple first introduced the ECG function in the Apple Watch in 2018 but sold it domestically without this feature activated because it had not obtained medical device approval.
According to the MFDS on the 2nd, Apple has passed the GMP conformity evaluation with the addresses of its headquarters and factory and was recognized as a Class 2 medical device. GMP conformity refers to an evaluation of whether a medical device manufacturer has established a system to manage the entire process from design, development, manufacturing, to marketing of the medical device.
Apple received GMP conformity approval as a product categorized as a "biological phenomenon measuring device." Although various devices fall under the category of biological phenomenon measuring devices, the most convincing interpretation is that Apple Watch will receive certification because it is the only product equipped with health-related measurement functions. Industry insiders view this as Apple’s preliminary step to activate the ECG function and other features on the Apple Watch.
Apple has equipped the ECG measurement function starting from the Apple Watch Series 4. An ECG measures the electrical impulses that cause the heart to beat, serving as an indicator not only of heart rate but also of whether the atria and ventricles are functioning regularly. In South Korea, Apple has not received certification from the MFDS to activate the ECG function, so the feature cannot be used. Some domestic users have bypassed this restriction by exploiting a bug during the iOS 13.4 update earlier this year, changing their country settings to use the ECG function.
Although Apple has passed the first stage of medical device certification, it cannot be ruled out that it will also seek approval for the ECG measurement app. If the Apple Watch is approved and sold as a medical device, there will be restrictions on sales channels. To actually sell the Apple Watch as a medical device in South Korea, a separate medical device sales license must also be obtained. Previously, Samsung Electronics received MFDS approval for a mobile app to provide blood pressure and ECG measurement functions. An MFDS official explained, "If a product is not certified as a medical device, it can be sold freely, but if it is certified as a medical device, it can only be sold at specialized medical device stores, which is why Samsung obtained approval for the app."
In the United States, Apple has received medical device approval from the FDA for its atrial fibrillation and ECG measurement app. Apple is aiming to enter the healthcare market by collaborating with local hospitals using the ECG function. However, even if the ECG function is activated on the Apple Watch in South Korea, the use of this data for medical treatment depends on the doctor's judgment. Remote medical treatment is prohibited under Korean medical law, so doctors cannot provide treatment or prescriptions based on this data. Current medical law deems "remote medical care," where treatment is provided through medical devices connected via communication networks without visiting a hospital, illegal.
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