As part of the Saudi Food & Drug Authority (SFDA) vision ‘to be a leading international science-based regulator to protect and promote public health’, the agency is updating its 2020 guidance on the classification and registration of combination products.
In connection with the guidance updates, a new regulatory framework is being developed to align with international best practices for regulating products that combine a drug or biologic medicinal product with a medical device.
Members of the SFDA Cross-Sector Combination Products Task Force hosted a webinar in mid-November to share the latest regulatory and technical requirements for combination products, explain the classification and registration pathways, and raise awareness about the guidance. Comments submitted are now being reviewed and updated guidance will be published in early 2026.
Implementation is planned in three phases, from submission according to the current data requirements (drug or device leading sector) in 2026-2027, to voluntary submission under the new guidance in 2027-2028, and mandatory submission from 2029-2030.
The Saudi FDA’s vision aligns with the broader Saudi Vision 2030, which aims to diversify the economy, empower citizens, and create a vibrant environment for local and international investors.
In 2023, the World Health Organisation (WHO) announced that Saudi Arabia had become the third regulatory system to reach WHO Maturity Level 4 for medicines and vaccines regulation, following evaluation using the Global Benchmarking Tool. Level 4 signifies that the SFDA is operating at an advanced level of performance with continuous improvement.
