The number of medical device approvals has been declining since the outbreak of the Covid-19 pandemic in early 2020 but domestic medical devices have outpaced imports in terms of approvals for three consecutive years, a government report showed. 

According to the report by the Ministry of Food and Drug Safety released on Tuesday, the total number of medical device approvals went down to 6,767 in 2022 from 7,060 in 2021. 

Among the total, 54.4 percent of the approvals were given to Korean medical devices, and 45.6 percent to imported products. 

The percentage of approvals for Korean products recorded at 51.6 percent in 2020, outpacing foreign products for the first time. Since then, the proportion of Korean medical devices continued to expand in approvals. 

An MFDS official attributed the better performance of Korean medical devices to local manufacturers’ active development of quarantine-related medical devices such as Covid-19 diagnostic reagents, sample collection tools, and skin infrared thermometers.

On the other hand, the number of licenses for imported medical devices has been declining since 2019. The figure slid for three consecutive years from 4,644 in 2019 to 3,088 in 2022. 

In particular, the approvals for eyeglasses and lenses, which are highly dependent on imports, showed a significant decrease from 575 in 2019 to 69 in 2022.