On 19th of May, AIDOT (CEO Jae-hoon Jeong) announced that it has obtained the Good Manufacturing Practice (GMP) certification from the Ministry of Food and Drug Safety,
guaranteeing the safety, efficacy, and quality management of in vitro diagnostic medical devices.
After acquiring the existing Medical Device Directive (MDD) GMP, AIDOT has obtained approvals for various artificial intelligence medical device software and has been progressing
with commercialization. Clinical trials are also underway for the developed products.
AIDOT is seen as establishing a foundation for the business of artificial intelligence in vitro diagnostic medical devices that utilize human-derived materials. In particular, with the
approval and commercialization of in vitro diagnostic medical devices currently being developed by AIDOT, such as the AI software for assisting the diagnosis of chronic
alcohol-related microbiome disorders (Class 2) and predicting the recurrence of thyroid cancer (Class 3), it is expected that there will be an acceleration in progress.
In vitro diagnostic medical device GMP (Good Manufacturing Practice) is a part of quality assurance that ensures that the medical devices produced by in vitro diagnostic medical
device manufacturers are safe, effective, and consistently produced with the intended purpose and use. It regulates the requirements that must be followed to guarantee the
quality of medical devices throughout the entire process, from the development of the medical device to the purchase of raw materials, manufacturing, inspection, packaging,
installation, storage, shipment, and claims, in order to consistently supply high-quality products.
With this, AIDOT has expanded its business scope to include in vitro diagnostic medical devices, in addition to medical devices, and the range of its self-developed products has
also broadened. It is anticipated that strategies for market entry and expansion into various product categories will become visible in the domestic and international markets,
which are actively progressing in the field of medical devices.
Korean economy TV / 21st. May. 2023 / Reporter Joon-sik Park