Korea to set national standard for 'autonomous electric wheelchair' lacking international benchmark

2024.07.18. The Fair Economy — The Ministry of Food and Drug Safety announced on the 18th that it has prepared proposals to establish or revise 142 national standards (KS) for medical devices, aiming to strengthen domestic quality and safety management standards for medical devices and align with international standards such as those of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The ministry will accept opinions until September 16.

The ministry will establish 40 new standards across 12 fields, including medical electrical equipment.

To boost exports, it will adopt international standards for 33 items in 12 fields, including 'anesthetic and respiratory equipment' and 'dentistry,' and will newly establish glossaries for fields such as 'medical electrical equipment' and 'surgical implants' to prevent user confusion.

Notably, the ministry will proactively develop and establish national standards in Korea for seven types that currently lack international standards, including 'autonomous electric wheelchairs' and 'automatic blood typing devices and reagents for blood cell agglutination tests for transfusion.'

Autonomous electric wheelchairs are devices developed to improve usability for severely disabled individuals who have difficulty using conventional electric wheelchairs. The new standard will ensure reliability by establishing performance requirements and test methods for 'continuous driving tests.'

The automatic blood type determination device and transfusion blood cell agglutination test reagent, which are directly linked to public safety and life, such as preventing transfusion accidents, lack domestic and international standards, so analytical performance evaluation guidelines are being proactively established this time.

The ministry will amend standards for 95 types across 16 categories, including diagnostic imaging equipment, and abolish seven types across five categories.

It will improve 42 standards by reflecting international standards, including 'particular requirements for basic safety and essential performance of dental extra-oral X-ray equipment,' and promote international harmonization of national standards by reflecting standard formats and terminology in 53 standards, including 'surgical instruments.'

Seven standards will be abolished, including those that overlap with the newly established and enacted glossaries for the medical electrical equipment field.

The Ministry of Food and Drug Safety said, "We expect this KS revision to harmonize domestic medical device quality standards with international standards, thereby helping to boost exports of high-quality medical devices, and we plan to lead the field of international standards in medical devices by proposing our standards as international standards."

The ministry also said it will continue to develop and provide standards based on scientific knowledge and regulatory science expertise to promote medical device development among domestic companies and further enhance the safety of medical devices in circulation.

Details of this administrative notice can be found on the 'Ministry of Food and Drug Safety website (mfds.go.kr) → Laws/Data → Legal Information → Legislative/Administrative Notices' or on 'e-National Standards Certification (standard.go.kr) → National Standards → KS Notices.'