MFDS Grants First Official Approval for COVID-19 Diagnostic Kit

[Asia Economy Reporter Choi Dae-yeol] The Ministry of Food and Drug Safety announced on the 1st that the COVID-19 diagnostic reagent developed by SD Biosensor has received official approval. While many products have been used on the front lines under emergency use authorization, this is the first time official approval has been granted.

This item has already received emergency use authorization and export approval using the molecular diagnostic (RT-PCR) method. This approval was obtained through procedures under the In Vitro Diagnostic Medical Device Act, including clinical trials and quality inspection standards (GMP), granting domestic manufacturing approval.

Typically, official approval takes more than a year, but this process was completed in about four months. This was made possible because the Ministry of Food and Drug Safety established a fast-track approval support plan for diagnostic reagents in April to prepare for the COVID-19 outbreak. The fast-track approval support plan is a temporary measure to encourage domestic manufacturing approval of COVID-19 diagnostic kits and will operate until October this year.

Yang Jin-young, Deputy Director of the Ministry of Food and Drug Safety, said, "This product is the first among emergency use authorization products used temporarily during infectious disease crisis situations to receive domestic approval after undergoing clinical trials and quality inspection standards review," adding, "It is significant in that it enhances international trust in quality and opens the way for stable supply of COVID-19 diagnostic reagents in domestic medical settings."

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