Medical Device Approvals Decline, but Domestic Products Lead Imports for 3 Consecutive Years

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Amid a decline in medical device approvals (licenses, certifications, and notifications) during the COVID-19 pandemic, domestic medical devices have surpassed imported products in approval share for three consecutive years.

According to the "2022 Medical Device Approval Report" published by the Ministry of Food and Drug Safety on the 25th, the total number of medical device approvals last year was 6,767, a decrease of 293 from the previous year (7,060). Among these, approvals for domestically manufactured products accounted for 3,679 cases (54.4%), while imported products accounted for 3,088 cases (45.6%). Although the total number of approvals has been declining since the outbreak of COVID-19, the proportion of approvals for domestically manufactured medical devices has gradually increased since it first surpassed imported medical devices at 51.6% in 2020. A Ministry of Food and Drug Safety official explained, "The sustained COVID-19 pandemic has influenced the increase in domestically manufactured products over the past three years, driven by active development of quarantine-related medical devices such as COVID-19 diagnostic reagents, specimen collection tools, and infrared skin thermometers based on excellent domestic technology."

On the other hand, approvals for imported medical devices have been continuously declining since 2019. The number of approvals for imported medical devices, which was 4,644 in 2019, decreased for three consecutive years to 3,088 last year. This decline is mainly attributed to a reduction in notifications and certifications among imported products. In particular, eyeglass lenses, which have a high import dependency, showed a significant decrease from 575 cases in 2019 to 69 cases in 2022.

The number of approvals for in vitro diagnostic medical devices was 1,012 last year, maintaining a similar level to the previous year (1,036). In vitro diagnostic medical devices saw a surge in approvals to 1,500 cases in 2020, nearly doubling from 760 cases in the previous year due to the COVID-19 outbreak, before shrinking to 1,036 cases in 2021. The proportion of in vitro diagnostic medical devices within the total medical devices was 9.2% in 2019, 18.3% in 2020, 14.7% in 2021, and 15.0% in 2022. While the approval share of medical devices last year was 12.9%, in vitro diagnostic medical devices accounted for a high share of 36.6%. This is due to the steady demand for self-test kits following the reorganization of the testing system by health authorities (from polymerase chain reaction (PCR) testing to antigen testing), which increased the number of approvals for antigen products. In fact, among the total 62 approvals for COVID-19 diagnostic reagents last year, antigen diagnostic reagents (34 cases) surpassed PCR diagnostic reagents (19 cases) for the first time. Twelve COVID-19 and influenza simultaneous diagnostic reagent products (2 PCR and 10 antigen) were also approved.

Software medical devices are also steadily being approved. The number of approvals for software medical devices, which was only 20 cases in 2018, increased to 97 cases last year, growing more than fourfold in four years. Among these, artificial intelligence (AI)-based software medical devices accounted for 41 cases, making up the majority. The number of approvals for medical devices requiring clinical trial data submission has also increased over the past three years (123 cases in 2020 → 133 cases in 2021 → 139 cases in 2022). As of last year, high-risk class 3 and 4 medical devices accounted for 124 cases, representing 89.2% of the total.

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