South Korea has created a procedure that allows makers of digital medical devices to have core components — such as artificial intelligence algorithms and sensors that measure vital signs — evaluated before the finished product wins approval. The change is expected to shorten the time it takes such devices to reach the market by easing the burden of having core technologies reviewed from scratch only after a full product has been developed.
The National Institute of Food and Drug Safety Evaluation, an arm of the Ministry of Food and Drug Safety, said on the 16th that it had issued a guideline on performance evaluations for digital medical device components. The document spells out the scope, application procedures and required documents for a new component performance evaluation system introduced under the Digital Medical Products Act, which took effect this year.
A component refers to a key part or program that performs an independent function while affecting the overall performance of a digital medical device. Typical examples include sensors that measure vital signs such as a patient's electrocardiogram or blood pressure, related software, and AI-based programs that carry out medical functions.
Previously, companies had to develop a finished product containing such technology and then have its performance assessed during the device approval process. Under the new system, the performance of core components such as AI algorithms or sensors can be evaluated by the ministry in advance. A digital medical device that uses an already evaluated component can then draw on those results when applying for approval, reducing the burden of proving the same core technology's performance again for each product.
The guideline includes criteria and examples for determining which technologies qualify for advance performance evaluation. It also lays out the application procedure, how to fill out the application form, and sample formats for supporting documents that must be submitted. The ministry said it ran a consultative body of experts, including manufacturers, importers and testing laboratories, to reflect industry views in the guideline.
Because digital medical devices often apply or update a single technology — such as software or an AI algorithm — across multiple products, the ability to evaluate core components first is also expected to improve predictability in product development. The guideline, however, only formalizes the advance evaluation procedure for components and does not eliminate the approval process for individual digital medical devices themselves.
The ministry expects the system to reduce development costs for the industry and shorten the time needed to bring products to market. It said it would continue to draw up related guidelines to support faster market entry for digital medical devices.
