Seoul National University Dental Hospital First KOLAS Accredited Dental Testing Institution

Seoul National University Dental Hospital’s Dental Medical Device Suitability Testing Center has achieved a milestone by becoming the first accredited testing institution in the dental field, as officially recognized by the Korea Laboratory Accreditation Scheme (KOLAS). 

This recognition, received on the 25th of April, is said to highlight the center’s commitment to providing specialized suitability testing services for dental medical devices and aims to enhance the international competitiveness of the domestic dental medical industry.

KOLAS Recognition System

The KOLAS testing institution recognition system evaluates the quality system and technical competence of testing institutions, formally recognizing their testing capabilities in specific fields. According to a press release, the resulting test reports issued by KOLAS carry international credibility, objectivity, and reliability, making them mutually accepted with accredited reports from major countries across the Americas, Europe, and Asia.

The Center embarked on the accreditation process by submitting the necessary application documents in November of the previous year. After undergoing thorough document review in January and on-site evaluation in March, it ultimately obtained recognition as a KOLAS accredited testing institution in the field of electrical testing for medical devices.

Evaluation Process

Suitability testing, a critical aspect of the center’s services, assesses the effectiveness, efficiency, and user satisfaction when utilizing medical devices as per the provided instructions within the intended use environment. This evaluation helps identify potential risks associated with usage errors and aims to prevent them from occurring during actual usage.

With the implementation of the Medical Device Act and In Vitro Diagnostic Medical Device Act, companies in the medical device industry must obtain Good Manufacturing Practice (GMP) certification to sell their products. Starting from July 2022, suitability testing has become mandatory as part of the evaluation process for all medical devices seeking GMP certification. This requirement emphasizes the significance of ensuring the safety and quality of dental medical devices.

Positive Step for Korean Dentistry

Director Lim Young-jun of the Dental and Life Sciences Research Institute expressed the center’s pride in this achievement, stating, “As the first KOLAS accredited testing institution in the dental field, we feel a great sense of responsibility. We will do our best to provide high-level suitability testing services specialized for dental medical devices in the future.”

Furthermore, Director Lee Yong-moo highlighted the positive impact of the accreditation on Seoul National University Dental Hospital, saying, “Through this recognition of the testing institution, our hospital can now deliver high-quality test results to dental medical device development companies. As the national central dental hospital, we will continue to make various efforts to enhance the international competitiveness of the domestic dental medical industry.”

The recognition of Seoul National University Dental Hospital’s Testing Center by KOLAS reportedly marks a significant step forward for the dental medical field in South Korea, ensuring rigorous testing standards and fostering innovation and competitiveness within the industry.