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Biomedical Testing Research Center Designated as a Medical Device Testing Institution

작성자대외협력과 작성일2019.09.20 09:23 조회70

CNU has been designated as a medical device testing institution to conduct testing procedures for the approval and registration on behalf of the Ministry of Food and Drug Safety.

According to CNU, the CNU Biomedical Testing Research Center (Director: Professor Park Sang-won, School of Dentistry) passed the qualification test on August 12. Therefore, CNU will be able to conduct physical and mechanical safety tests, biocompatibility tests (Biological safety tests), and specified performativity tests of the designated product groups for domestic medical device manufacturers and importers.

There are twenty-six medical device inspections and CNU received an approval for five item groups such as medical instruments for treatments, implantable medical devices, artificial human tissues or functional substitutes, materials for dental alloys, and materials for dental treatment. CNU will apply for additional categories of testing groups to expand its capacity.
 
The Biomedical Testing Research Center is also applying for the GLP (Good laboratory practice) certification to be recognized as a non-clinical testing institution to guarantee reliability in areas requiring safety evaluation for developing and selling products for orthopedic surgery, contact lenses, and cosmetics produced by local Gwangju industrial manufacturers of medical supplies.

GLP certification is conferred to the manufacturing facilities that fulfill regulations to ensure the reliability required for the safety assessment of pharmaceuticals and medical devices, and cosmetics.

The center has been preparing for the designation of medical device testing and inspection institutes with 2 billion KRW from the Gwangju Metropolitan city government’s budget and funding of 500 million KRW respectively from the CNU Industry-University Liaison Office and CNU Hospital. This fruitful result is expected to contribute to the activation of medical industries, which have been fostered and touted as the future industry of Gwangju- this will increase the city’s attractiveness to companies in related fields and increase employment.

Professor Park said, “We will try to contribute to the development of Korea's medical industry across the region through the excellent test evaluation and clinical capability of CNU and CNU Hospital”.