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Clinical Investigations in Saudi Arabia

When are in-country clinical investigations needed?​

Clinical investigations conducted in Saudi Arabia may be necessary when:

  • The SFDA requires clinical data specific to the Saudi patient population
  • A novel device lacks sufficient clinical evidence from other markets
  • PMCF studies are required for Class C or D devices
  • A manufacturer wishes to generate Saudi-specific evidence to support MDMA

SFDA authorisation for clinical investigations​

Before conducting a clinical investigation in Saudi Arabia, manufacturers must obtain:

  1. SFDA approval — formal authorisation of the clinical investigation plan
  2. Ethics committee approval — from the relevant institutional review board (IRB) or the Saudi National Committee of Bioethics

Applications for clinical investigation approval are submitted via GHAD.

Clinical investigation plan requirements​

The clinical investigation plan must address:

  • Investigational device description and intended use
  • Objectives and hypothesis
  • Study design and patient population
  • Primary and secondary endpoints
  • Statistical methodology
  • Risk management plan for the investigation
  • Monitoring and data management plan
  • Adverse event reporting procedures

Using overseas clinical data for MDMA​

Where clinical investigations in Saudi Arabia are not required, the SFDA accepts clinical data generated in other countries, provided it is relevant to the Saudi patient population. Clinical data from GHTF-member markets (EU, US, Canada, Japan, Australia) is generally accepted with appropriate bridging justification.

Further reading​