The Korea Disease Control and Prevention Agency (KDCA) will establish the “National Standard Implementation Plan for Medical Devices in 2023” to lead international standards and help domestic medical equipment makers advance overseas.
The main content of the implementation plan includes a push to win the final approval from the International Organization for Standardization (ISO) for two existing international standard plans suggested by Korea, three new international standard plans, and Korea’s hosting of international assemblies for electrical medical products, the agency said Wednesday.
“We are doing our best to ensure that medical device technology in which Korea has strengths can be enacted as the ISO standards,” the KDCA said.
The agency noted that it is continuously participating in ISO’s general assembly and working-group meetings and positively presenting its opinions so that ISO approves the two international standards in dentistry it had submitted this year, adding that it would suggest three new international standard plans this year to lead making international standards in medical devices.
More specifically, KDCA is promoting to get the ISO’s final nods for “general requirements for non-hinged dental handhelds” and “frontal apparatus - part 4: auxiliary apparatus" as international standards in dentistry. In addition, it will push to make three new standards -- general requirements for hinged hand tools for dentistry,” “focused tube equipment - part 8: precision of electronic root tube length meter,” and the “classification of dental equipment and devices according to reprocessing – as international standards.
Besides, the agency is pushing to streamline 144 Korea Standards in various areas -- 22 standards related to electric and electronic medical devices, 110 related to dental, surgical, and in vitro diagnostic areas, and 12 related to individual medical devices and those used by the vulnerable class.
Meanwhile, the agency plans to hold an international assembly of electric medical devices to be attended by about 150 experts from 20 countries in September to heighten Korea’s status in the international community regarding this field.
The international meetings planned by the agency are the general assembly of the International Electro-technical Commission (IEC) and its technological group, TC (Technical Committee) 62, which deals with electric and mechanical safety, risk management, validation, and data security.
In these meetings, participants will discuss and decide on making and revising international standards regarding electrical medical products' safety and essential function, including diagnostic imaging devices and radiation devices, the agency said.
“We will communicate with relevant experts based on regulatory expertise and maintain national standards (KS) continuously to ensure that the public can use high-quality medical devices with confirmed safety and high performance,” the KDCA said. “In addition, by reflecting Korea's strong technical standards in the field of medical devices in international standards, we will actively support to enhance the status of the domestic medical device industry and help K-medical devices advance into overseas markets.