«الغذاء والدواء»: مخالفات الجودة تعلق استيراد منتجات مصنع طبي

The Saudi Food and Drug Authority has suspended the import of products from a medical devices and supplies factory located outside the Kingdom, as part of its ongoing efforts to verify the safety of products under its supervision that are traded in the Saudi market.

During a field inspection, the Authority's inspectors identified serious violations related to the quality management system, manufacturing processes, and the work environment within the factory, which could lead to contamination of medical devices. Violations related to quality management systems accounted for 10% of the total violations recorded against medical device factories last year, while violations related to manufacturing processes and the work environment reached 49%.

The Authority confirmed that this action is part of a series of measures taken when serious violations are detected during its inspection visits to factories of medical devices and supplies exported to the Kingdom, with the suspension rate for imports being 30% of the factories inspected last year. The factory is registered with several international regulatory bodies, including the U.S. Food and Drug Administration (FDA) and the European Union, and its products are marketed in various markets around the world, highlighting the efficiency of the Authority's regulatory system and its ability to detect substantial violations and take necessary actions, based on a precise inspection methodology that aligns with best international practices.

The Drug Authority stated in its announcement that the suspension decision reflects its commitment to enhancing oversight of the imported medical devices sector and ensuring that all products in circulation are safe and effective, thereby protecting public health and preventing the circulation of any products that pose a risk to consumers. It reaffirmed its commitment to taking all necessary measures to maintain safety standards in this vital sector.