SFDA suspends medical device imports from erring international firm
Saudi Gazette report
RIYADH — The Saudi Food and Drug Authority (SFDA) has suspended imports from an international medical device and supplies factory, as part of its ongoing regulatory efforts to verify the safety of products under its supervision circulating in the Saudi market.
This import suspension decision followed an SFDA inspection tour that uncovered serious violations, according to a press statement from the authority on Thursday. These issues primarily centered on the factory's quality management system, manufacturing processes, factory work environment and deficiencies that could potentially lead to the contamination of medical devices.
Violations related to quality management systems accounted for approximately 10 percent of all recorded violations at medical device factories in 2024. Meanwhile, violations concerning manufacturing processes and the work environment represented a significant 49 percent of the total.
According to the statement, this action is one of several measures the SFDA takes when serious violations are found during inspections of facilities exporting medical devices to Saudi Arabia. The import suspension rate reached approximately 30 percent of all factories inspected in 2024.
The factory is also registered with several international regulatory authorities, including the US Food and Drug Administration (FDA) and the European Union, and its products are marketed globally. This demonstrates the efficiency and precision of the SFDA's regulatory system, highlighting its strong capabilities in detecting significant violations and implementing necessary measures based on an inspection methodology that aligns with international best practices.
The SFDA is committed to rigorous oversight of the imported medical device sector, ensuring that all products in circulation are safe and effective to protect public health and prevent the distribution of potentially harmful devices. It reaffirmed its dedication to implementing all necessary measures to uphold safety and quality standards in this vital sector.
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