Yonsei University obtains additional qualifications for screening medical device technical documents, and other devices are also possible
Oct 19, 2024
The subject of technical document review by Yonsei University Dental Medical Device Test Evaluation Center has been expanded.
In accordance with the regulations on the designation of a medical device technical document review agency, the Ministry of Food and Drug Safety selects an agency to review technical documents on medical device items. The Yonsei University Dental Device Test and Evaluation Center (hereinafter referred to as the Evaluation Center) was designated as a screening agency in June 2020.
Until now, the evaluation center has only reviewed technical documents on dental devices, but after recent deliberations by the Ministry of Food and Drug Safety, the review items have been expanded to all areas of medical device supplies. The subjects of the examination included not only dental-related medical devices, but also medical devices used in cardiology and ophthalmology such as cardiovascular machinery, surgical instruments, vision correction lenses, and drug injectors.
The evaluation center conducts complex evaluations such as technical documents, test tests, and biological safety for medical device licensing, and has also started chemical analysis services essential for issuing Biological Evaluation Report (BER) from this year.
Kwon Jae-sung, head of the Dental Medical Device Test and Evaluation Center (chief professor of dental biomaterial engineering class), said, "We will provide broader evaluation services as the evaluation items have been expanded from dentistry to other departments such as cardiology. We will do our best to contribute to the improvement of patient health by marketing safe medical devices in domestic and international markets."."
In accordance with the regulations on the designation of a medical device technical document review agency, the Ministry of Food and Drug Safety selects an agency to review technical documents on medical device items. The Yonsei University Dental Device Test and Evaluation Center (hereinafter referred to as the Evaluation Center) was designated as a screening agency in June 2020.
Until now, the evaluation center has only reviewed technical documents on dental devices, but after recent deliberations by the Ministry of Food and Drug Safety, the review items have been expanded to all areas of medical device supplies. The subjects of the examination included not only dental-related medical devices, but also medical devices used in cardiology and ophthalmology such as cardiovascular machinery, surgical instruments, vision correction lenses, and drug injectors.
The evaluation center conducts complex evaluations such as technical documents, test tests, and biological safety for medical device licensing, and has also started chemical analysis services essential for issuing Biological Evaluation Report (BER) from this year.
Kwon Jae-sung, head of the Dental Medical Device Test and Evaluation Center (chief professor of dental biomaterial engineering class), said, "We will provide broader evaluation services as the evaluation items have been expanded from dentistry to other departments such as cardiology. We will do our best to contribute to the improvement of patient health by marketing safe medical devices in domestic and international markets."."
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