Saudi Arabia: Adopted Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices
Description
Adopted Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices
On 29 November 2020, the Saudi Food & Drug Authority adopted the Guidance on Artificial Intelligence (AI) and Machine Learning (ML) technologies based Medical Devices. The Guidance sets out requirements for obtaining medical markets marketing authorisations for AI and ML technologies based medical devices which are required for their release on the market.
Original sourceScope
Policy Area
Authorisation, registration and licensing
Policy Instrument
Authorisation of goods or services
Regulated Economic Activity
ML and AI development, other service provider
Implementation Level
national
Government Branch
executive
Government Body
other regulatory body