Dr. Miriam Boles

Position: Head of the Central Administration of Medical Devices, Egyptian Drug Authority (EDA)
Categories: MedDevreg Speakers 25

Dr. Miriam Boles currently serves as the Head of the Central Administration of Medical Devices at the Egyptian Drug Authority (EDA). She holds a Bachelor’s degree in Pharmaceutical Sciences from a well-established Egyptian university and a Master’s degree in Business Administration with a specialization in Supply Chain Management from the Arab Academy for Science, Technology & Maritime Transport (AASTMT).

With over two decades of experience in the medical device regulatory sector, Miriam has built a distinguished career in public service. She began her journey as a Medical Devices Registration Reviewer, later advancing to Senior Reviewer, and subsequently to Director of the Medical Devices Unit. In November 2020, she was appointed as the Head of the Central Administration of Medical Devices at the EDA.

In her leadership role, Miriam is dedicated to developing and implementing strategic plans for premarket regulation of medical devices and in-vitro diagnostics (IVDs), in alignment with the EDA’s mission to ensure the safety, quality, and effectiveness of medical devices in Egypt.

Key Achievements under her leadership include:

  • Egypt, represented by the Egyptian Drug Authority, became the Vice Chairman of the African Medical Devices Forum (AMDF) in April 2025, winning the position for a three-year term.
  • Egypt, represented by the EDA, became an Affiliate Member of the International Medical Device Regulators Forum (IMDRF) in October 2023.
  • Egypt, represented by the EDA, became a Permanent Member of the Global Harmonization Working Party (GHWP) in December 2023.
  • The Egyptian Drug Authority joined the African Medical Devices Forum (AMDF) in February 2024.
  • Enhanced localization of numerous medical devices and equipment.
  • Implemented Unique Device Identification (UDI) for all medical devices circulating in the local market in October 2022.
  • Established “MeDevice”, an online platform for automating administrative processes and enabling electronic archiving in 2021.
  • Developed a national procedure to regulate the importation and circulation of laboratory and IVDs — the first of its kind in Egypt in 2021.
  • Issued comprehensive regulatory guidelines for premarket approvals, unique device identification (UDI), and labeling requirements.

Dr. Miriam is recognized for her dedication, professionalism, and passion for regulatory excellence. She values teamwork, positivity, and motivation through achievement. Her interests include data analysis, problem-solving, and continuous learning — particularly in staying updated with global developments in medical device and IVD regulations.