Kingdom of Saudi Arabia
2023-02-28

KEYU series Feces Analyzers and related reagents have been granted the MDMA (Medical Device Marketing Authorization) by SFDA (Saudi Food and Drug Authority).

SFDA was established in 2003. The main objectives of the SFDA is to ensure safety of food, drug for human and animal, safety of biological and chemical substance as well as electronic devices that related to human health. This is a good start for KEYU to successfully exploit the Middle East market.

The Kingdom of Saudi Arabia is the largest market for medical devices in the GCC region. SFDA medical device registration regulations are based on existing regulations in Australia, Canada, the European Union, Japan and the United States.

At the same time, SFDA regulatory authorities are very careful when reviewing application materials for medical devices, especially in terms of consistency of the required documentation. As a professional service provider of in vitro diagnostics, KEYU passed the rigorous review with high standards of products. Previously, KEYU series Feces Analyzer had been granted access to the EU market, thus accelerating the approval of the SFDA.

The SFDA certification is a full recognition of the quality of the KEYU series product, which lays a good foundation for KEYU to Develop global market and serve more people.

       

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