Saudi Arabia has issued a stern warning against violations involving medical devices, announcing severe legal consequences for unauthorized distribution or sale. The Saudi Food and Drug Authority (SFDA) clarified that it is illegal to market or use medical devices for purposes beyond their intended function without obtaining mandatory prior approval. This crackdown follows the recent inspection of a commercial establishment, which was referred to public prosecution for operating without the necessary permit.
The SFDA emphasized its zero-tolerance policy toward actions that endanger consumer safety. Under Saudi law, offenders can face penalties of up to 10 years in prison or a fine of up to 10 million Saudi riyals, or potentially both. These stringent measures are intended to enforce compliance with national standards that ensure the quality and safe use of medical products.
The authority highlighted that prior approval is essential to verify that medical devices meet established safety and performance standards. The violation by the cited establishment was reported by the Saudi Press Agency as a breach of both medical device regulations and the official distribution system. The SFDA urges all commercial entities to strictly adhere to regulatory requirements to avoid severe legal repercussions.
In an effort to safeguard public health, the SFDA has also encouraged citizens and residents to report any suspected violations. The public can contact the authority via the toll-free number 19999 to provide information on unauthorized medical device activities. This initiative underscores the government’s commitment to protecting consumers and maintaining rigorous oversight in the healthcare sector.
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