Medical devicemakers must now obtain approval from the Saudi Food and Drug Administration before starting clinical investigations in the country, under guidance released May 27.
No investigational device will be cleared from any port of entry before obtaining SFDA approval. However, sponsors may submit a port of entry clearance letter prior to the agency’s completion of the review process.
Applicants must provide a signed agreement with the clinical investigation site and the contract research organization, if applicable, an approval letter from the investigation review board, the clinical investigation plan and the investigator brochure.
The guidance also sets out requirements for labeling and progress reports on investigational devices. Labeling must include the manufacturer’s name and address, the intended use, the residual risks and a cautionary note.
The label and instructions may be in English if the users are likely to be qualified professionals. Instructions for importers and distributors on handling, storage and transportation, however, should be in both English and Arabic, the guidance says.
The guidance also explains the timeframes in which principal investigators and sponsors must submit progress reports on topic such as adverse effects, plan deviations, recalls, withdrawal of approval and premature termination. Companies should send a clinical trial report to the SFDA and reviewing IRBs within six months of the study’s completion or termination.
In the case of emergency deviations, sponsors must notify the SFDA no later than two calendar days after the emergency occurred.