KFDA to approve in vitro diagnostics as OTCs

The KFDA plans to switch in vitro diagnostics into OTCs in a bid to foster a biotechnology industry and protect the consumers.

Noting that since a majority of self-test kits are classified into prescription drugs except for pregnancy diagnosis, diabetic and blood sugar examinations, their limited use in hospitals and clinics does not satisfy the needs of customers, the KFDA intends to switch...