Overview Medical

Medical Devices Sector at Saudi Food and Drug Authority plays a pivotal role ensuring safety, efficacy and performance of medical devices under a comprehensive legislation and regulation. Indeed, Saudi Medical Devices regulatory frame is aligned with international practice in terms of harmonization and convergence where it chaired the Global Harmonization Working Party (GHWP) and active member in many technical committees in IMDRF and ISO.

Medical Devices Regulation covers the entire lifecycle for medical devices starting from the idea, concept, manufacturing process and ending by reaching the product to end users in addition to monitoring the performance and safe use of medical devices.

The sector performs series of regulatory activities including reviewing the technical file of medical devices, clinical trials, postmarket surveillance plan, quality and other technical documents prior to granting the marketing authorization. Moreover, monitoring the approved devices via a well-designed model of post market surveillance focusing on the risk based approach. analyzing field safety notices, adverse events and other safety signals to ensure high degree of safety and efficacy of Medical devices. Also, communicating effectively with the healthcare providers, sharing series of updated safety communication recommendations and vigilance reports. In addition, the sector oversight and monitoring the medical radiation emitting devices, medical radioactive material and radiation protection and safety at healthcare providers ensuring the compliance of these radiology departments, nuclear medicine, radiotherapy, dermatology, and dentals clinics with SFDA regulatory requirements.

Based on its wide experience, the sector is managing a unique center with World Health Organization (Saudi FDA WHO- Collaboration Centre). The center provides international services to WHO and other countries in terms of training, workshops and the active participation of SFDA experts in many projects.