The Saudi Food and Drug Authority (SFDA) has granted marketing authorisation to two locally developed medical software products that use artificial intelligence in diagnostic support. The decision provides an example of how such products can progress through the Saudi regulatory process. It does not represent a general change to the rules for all medical devices.
The first product, Dental IQ, analyses dental X-rays and helps healthcare professionals identify potential signs of disease. The second, SAARIA, analyses retinal images to support screening for diabetic retinopathy. Both products are intended to support, rather than replace, professional clinical judgement.
According to the SFDA, the developers took part in its Innovative Medical Devices Pathway. The regulatory review included technical documentation and clinical evidence, as well as clinical studies conducted in Saudi Arabia. The developers also committed to clinical follow-up after the products enter the market.
For Slovenian medical technology companies, the cases are particularly relevant because of the emphasis on local validation. Companies considering entry into the Saudi market should assess the requirements applicable to their specific product and its intended use.
Source: SFDA: marketing authorisation for Dental IQ and SAARIA.