The Ministry of Food and Drug Safety (MFDS) issued an administrative notice Friday that it would establish, revise and abolish 166 Korean Standards (KS) in the medical devices area and receive comments until Aug. 13.

The notice is designed to improve the quality and safety of Korean medical devices and harmonize them with international standards, including those of the International Electrotechnical Commission (IEC).

In detail, it will establish KS for 34 devices in 14 areas, including diagnostic imaging devices, revise 99 KS in 17 fields, including dental and surgical instruments, and abolish 33 KS in 10 fields, including anesthesia and respiratory devices and surgical implants.

More specifically, the notice also calls for the internationally harmonizing basic safety and essential performance requirements for “diagnostic X-ray devices” and “dental units” highly used in the industry, introducing a validation method for “in vitro diagnostic medical devices” to help domestic industry reinvigorated their exports, and establishing domestic standards for performance evaluation, such as testing physical and chemical properties of “contact lenses.”

In particular, the ministry plans to increase the reliability for the safety and validity of domestic medical devices by preemptively establishing its own standards for “paraffin baths,” “antinuclear antibodies,” and “automated reading devices,” for which no domestic or international standards have been established, and propose them as international standards.

Industry officials can find more information on this administrative notice by visiting the ministry’s website (mfds.go.kr) or the e-Korean Standards certification website (standard.go.kr).