The Saudi Food and Drug Authority (SFDA) has suspended imports from an international medical device and supplies manufacturer. This action is 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. These issues primarily centered on the manufacturer's quality management system, manufacturing processes, and factory work environment, deficiencies that could potentially lead to the contamination of medical devices.

Violations related to quality management systems constituted about 10% of all violations recorded at medical device factories in 2024. Meanwhile, violations concerning manufacturing processes and the work environment represented a significant 49% of the total.

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. In fact, the import suspension rate reached approximately 30% of all factories inspected in 2024.

It's important to note that this specific 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 powerfully 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.

This action reflects the SFDA's commitment to robust oversight of the imported medical device sector. It ensures that all products in circulation are safe and effective, thereby protecting public health and preventing any risky items from reaching consumers. The SFDA firmly reiterates its dedication to implementing all necessary measures to uphold safety standards in this crucial sector.