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Reporting Medical Device Incidents & Adverse Events to SFDA

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The Author

Heba Rasheed

Reporting medical device incidents, complaints, and adverse events is the essential post-marketing surveillance activity companies and their authorized representative (AR) must comply with in Saudi Arabia. The objective of reporting and subsequent evaluations is to improve the safety of patients, users, and others by disseminating information that may reduce the likelihood of or prevent the repetition of adverse events or alleviate the consequences. The monitoring process shall start after the SFDA medical device approval and continue in the market as long as the product is supplied.

Who Should Report?

Manufacturers, authorized representatives, importers, distributors, and healthcare providers.

Where to Report?

Adverse event reports and related documents can be reported to SFDA through one of the following channels:

Reporting Regulation

Manufacturers, authorized representatives, importers, and Distributors shall:

  • Report the following to the NCMD:
    • Incidences
    • Adverse events (Side Effects)
    • Complaints
    • Follow up investigation
    • Device deficiencies
    • Cases related to clinical trials.
    • All documents and information related to the case.
  • Appoint an authorized person to communicate with the SFDA.
  • Establish a tracking system to record all information related to the supply and distribution of
    medical devices.
  • Document and implement written work procedures to follow up on incidents and adverse events of
    medical devices.

Required Documents

Occurred Inside Saudi Arabia

  • Initial Report
    An initial report is the first information submitted about the adverse event. Reporters shall provide the investigation reports, technical documents, and test reports related to the medical device associated with the adverse event based on the investigation stage and the availability of the information. The initial report shall include the information mentioned in the SFDA medical device reporting form.
  • Follow-up Report
    A report that provides supplementary information about adverse events that was not previously available, such as additional information, investigation progress, and actions taken. If the investigation takes over thirty days, a justification shall be submitted to SFDA for assessment.
  • Final Report:
    The last submitted adverse event report shall contain all information, details, actions taken, and final recommendations. It also shall specify the implemented CAPA by the manufacturer or the authorized representative for SFDA assessment.

Occurred Outside Saudi Arabia

Incidents and adverse events that occurred outside Saudi Arabia but have potential Consequences on a product in the Saudi market need to be submitted to the SFDA. The data shall include all available details on the medical device and measures taken. Also include the Field Safety Corrective Action (FSCA), If applicable.

Reporting Timeframe:

Manufacturers or their AR shall report to the SFDA upon becoming aware that an incident or adverse event has occurred; the timeframe is as follows:

  • Not later than (2) calendar days
    If the incident or adverse event represents a serious public health threat.
  • Immediately, not later than (10) calendar days
    For the incident or adverse event that results in unanticipated death or unanticipated serious injury.
  • Not later than (30) calendar days
    For all other incidents and adverse events.
  • Investigation procedures
    Shall be concluded, and the final report shall be submitted within:
    • (15 days) from the date of occurrence or awareness of adverse events or complaints
      that do not require testing or technical evaluation.
    • (30 days) from the date of occurrence or awareness of adverse events or complaints
      that require testing the device inside KSA.
    • (60 days) from the date of occurrence or awareness of adverse events or complaints
      that require testing the device outside KSA.
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The Author

Heba Rasheed

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