The Egyptian Drug Authority (EDA) held a virtual meeting with the Health Sciences Authority of Singapore (HSA) to discuss the inclusion of HSA among the Egyptian Drug Authority’s list of reference countries for medical devices, and to explore opportunities to strengthen technical and technological collaboration in this field.
The meeting was attended on behalf of the EDA by Dr. Miriam Boulos, Head of the Central Administration of Medical Devices, while the Singaporean side included Ms. Chua Siew Wee, Deputy Director of the External Engagement Office; Ms. Ong Shu Yi, Senior Manager at the same office; Mr. Desmond Sim, Director of the External Engagement Office; and Mr. Ong Ming Hao, Regulatory Consultant at the Medical Devices Cluster.
The meeting was held in light of the growing international confidence in the Authority’s regulatory system, as the EDA seeks to update its list of reference countries in accordance with the latest global standards and to benefit from leading international expertise. The Health Sciences Authority (HSA) of Singapore is classified as Maturity Level 4 (ML4) by the World Health Organization in the medical devices sector, which represents the highest international classification in this field.
For her part, Dr. Miriam Boulos, Head of the Central Administration of Medical Devices, delivered a presentation on the current regulatory reliance framework in Egypt, emphasizing the Authority’s aspiration to enhance its regulatory efficiency and progress toward achieving Maturity Level 4 through the exchange of expertise and international best practices to support and further develop the Egyptian regulatory framework.
Discussions addressed several priority technical topics, including regulatory frameworks for emerging medical technologies—particularly Software as a Medical Device (SaMD) and artificial intelligence applications—alongside the development of quality management systems (QMS) and the strengthening of post-marketing surveillance mechanisms.
The Singaporean side also presented its risk-based regulatory framework, facility licensing mechanisms, and strict adherence to global quality standards, reinforcing its position as an international model to be emulated in ensuring the safety and quality of medical devices.
The meeting concluded with reaffirmation that cooperation with Singapore within the framework of the Egyptian Drug Authority aligns with Egypt’s direction toward localizing the latest medical technologies and strengthening collaboration with leading international entities. This supports accelerating the availability of innovative and safe medical solutions for Egyptian citizens in accordance with global best practices.
This comes as part of the Egyptian Drug Authority’s ongoing commitment to strengthening international cooperation and localizing best regulatory practices to ensure the safety and quality of medical devices in the Egyptian market.