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Saudi FDA: Clinical investigation of COVID-19 devices not approved

Legal action taken against a company for conducting tests without prior approval

Last updated:
Samir Salama, Associate Editor
1 MIN READ
Shutterstock
Shutterstock
Shutterstock

Abu Dhabi: Saudi Food and Drug Authority has confirmed the clinical study announced by a company regarding the completion of testing of the effectiveness of rapid examination devices for COVID-19 has not been approved.

The authority requires prior approval before conducting any clinical investigation of a medical device within the Kingdom.

The pre-approval requires the submission of a technical file for the device, in addition to the approval of the local research ethics committee.

The Saudi FDA confirmed that legal action has been taken against the company, calling on all relevant sectors to follow official procedures.

The authority regulates medical device clinical investigation through:

  • Developing regulations for conducting clinical studies.
  • Reviewing and evaluating clinical studies applications.Inspection visits to clinical studies sites.
  • Collaborating with clinical Investigations stakeholders to enhance the quality of clinical research in the Kingdom.

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