SFDA Approves First Dual Glucose-Ketone Monitor

The Saudi Food and Drug Authority granted marketing authorization in August 2026 for an innovative medical device that offers continuous, simultaneous monitoring of glucose and ketone levels. Built on next-generation biosensor technology, it is the first device of its kind to be authorized in Saudi Arabia.

The approval was issued under the Medical Device Marketing Authorization (MDMA) system, which since January 2022 has been the mandatory route for any medical device placed on the Saudi market. Applications for such devices are submitted through the authority's dedicated electronic MDMA system, known as the GHAD platform.

How the process works

Under the MDMA framework, government assessment fees are set according to the device's risk classification (Class A to D), ranging from 15,000 SAR for Class A up to 23,000 SAR for Class D. Renewing an existing certificate carries a reduced fee of 5,000 SAR, while administrative changes such as label updates or minor manufacturer details cost 1,100 SAR. Changes affecting a device's risk classification or the legal manufacturer's name and address are charged the full fee again.

Other related costs include an Authorized Representative annual license fee of about 2,600 SAR, and Unique Device Identifier (UDI) code fees of roughly USD 15 for fewer than 150 codes and USD 18 for fewer than 500 codes. Review timelines for new applications typically range from 35 to 60 working days, depending on product type, risk class, and the number of products included.

For residents managing diabetes and related conditions, a locally authorized device that tracks both glucose and ketones at the same time could simplify daily monitoring and support earlier detection of complications. The authorization also reflects the Kingdom's steady expansion of access to advanced medical technologies through a regulated, transparent pathway.

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