AIDOT (CEO Jung Jae-hoon) announced on May 19 that it has obtained GMP certification issued by Korea’s Ministry of Food and Drug Safety (MFDS), which verifies the safety, effectiveness, and quality management of in vitro diagnostic (IVD) medical devices.

Following its prior acquisition of GMP certification for conventional medical devices (MDD), AIDOT has continued to secure regulatory approvals for various AI-based medical device software products and advance commercialization, while also conducting clinical trials for products under development.

AIDOT stated that this newly obtained IVD GMP certification establishes a foundation for expanding into AI-driven IVD medical devices that utilize human-derived specimens. The company expects this to accelerate both regulatory approval and commercialization efforts for its current IVD pipeline, including a chronic alcoholic liver disease microbiome diagnostic support AI software (Class II) and a thyroid cancer recurrence prediction diagnostic support AI software (Class III).

IVD GMP certification (Quality Management Compliance Recognition) is described as part of a quality assurance framework intended to ensure that IVD medical devices manufactured by a company are produced consistently at a high level of quality—safe, effective, and fit for their intended use. It covers requirements across the full lifecycle and operations, including development, raw material procurement, manufacturing, inspection, packaging, installation, storage, shipment, and complaint handling.

With this certification, AIDOT said it can now expand its business scope beyond medical devices into the IVD medical device sector, broaden the range of products it can develop, and pursue clearer strategies to enter and scale in both domestic and international markets with a more diverse product lineup.

Published: May 21, 2023 / Korea Economic TV / Reporter Park Jun-sik