'Revised Guidelines for COVID-19 Diagnostic Device Evaluation Aligned with International Standards'

MFDS Supports Commercialization of In Vitro Diagnostic Medical Devices in Harmony with Global Regulations

The Ministry of Food and Drug Safety announced on the 13th that it has revised the related guidelines to align with global standards by relaxing some conditions that were recommended during the approval and review of COVID-19 in vitro diagnostic medical devices. The performance evaluation guidelines for high-risk infectious agents were also revised and distributed to harmonize with international standards.

When approving and reviewing COVID-19 diagnostic devices using the polymerase chain reaction (PCR) method, the Ministry previously recommended detecting two or more COVID-19 virus genes, but this condition has been removed in the new guidelines. This measure was taken considering that the World Health Organization (WHO), the United States, and Europe do not separately limit the number of detected genes.

Considering that the majority of the public has experience using COVID-19 self-test kits, the usability evaluation data will also be simplified. Usability evaluation is a test to confirm whether non-experts can accurately use the product based only on instructions for use. From now on, usability evaluation data will only need to be submitted if the product or usage method differs from existing products.

The Ministry also recommended evaluation of major COVID-19 virus variants (Alpha, Beta, Gamma, Delta, Omicron) designated by the WHO and provided detailed evaluation methods.

Clinical performance standards for influenza antigen test reagents and high-risk virus (HIV, HBV, HCV, HTLV) test reagents were also aligned to international performance levels.

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, said, "We expect this guideline revision to help the development of excellent diagnostic medical devices domestically," and added, "We will continue to proactively present internationally harmonized approval and review standards to actively support the in vitro diagnostic medical device industry in securing global competitiveness."

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