The Ministry of Food and Drug Safety (MFDS) has opened the door for people to test themselves at home for sexually transmitted diseases, drugs, and influenza.
The MFDS said Sunday it issued an advance notice of a revised regulation on "Classification and Grade of In Vitro Diagnostic Medical Devices," expanding the range of in vitro diagnostic devices approved for self-testing.
Under the revised regulation, self-test products will be eligible for approval in three areas: sexually transmitted infection agents including syphilis, gonorrhea, chlamydia, and trichomonas; drug metabolites; and influenza viruses.
The move expands the self-testing market, which had been limited primarily to COVID-19 rapid test kits, into areas such as STDs and narcotics. The MFDS has been pursuing the regulatory reform since September last year, reflecting input from the medical community, industry, and consumer groups. COVID-19 self-test products will be reclassified from the existing mid-level category system to a product-specific subcategory system, aiming to refine the management framework by function.
The MFDS plans to strengthen labeling requirements on the outer packaging of self-test products, including a "for self-testing" mark and enhanced precautions, while also conducting education and public awareness campaigns on specimen collection and result interpretation. "This regulatory improvement will contribute to early response to infectious diseases and prevention of drug misuse, and will also have a positive impact on expanding people's right to self-determination in health," an MFDS official said. "However, self-test results should be used as a supplementary tool before visiting a medical institution," the official stressed.