After two years of preparation, Beijing Lingze Medical has successfully obtained Medical Device Marketing Authorization (MDMA) from Saudi Arabia's Food and Drug Authority (SFDA) on June 25, 2025. This approval covers our full product line, including PICC catheters, enteral feeding pumps, enteral feeding sets, TPN bags, and nasogastric tubes, marking a significant step in our expansion into the Saudi market.
The medical device regulatory authority in Saudi Arabia is the Saudi Food & Drug Authority (SFDA), which is responsible for regulating, supervising, and monitoring food, pharmaceuticals, and medical devices, as well as establishing mandatory standards for them. Medical devices can only be sold or used in Saudi Arabia after being registered with the SFDA and obtaining Medical Device Marketing Authorization (MDMA).
The Saudi Food and Drug Authority (SFDA) requires medical device manufacturers to appoint an Authorized Representative (AR) to act on their behalf in the market. The AR serves as the liaison between foreign manufacturers and the SFDA. Additionally, the AR is responsible for product compliance, safety, post-market obligations, and medical device registration renewal. A valid AR license is mandatory for customs clearance during product importation.
With our SFDA certification now in place, L&Z Medical is fully prepared to supply Saudi healthcare institutions with our complete line of medical products. Stay tuned for more updates as we continue expanding our presence in the Middle East market.
Post time: Jun-25-2025