Building regulatory capacity and exchange of experts has always been a key objective for WHO. A number of WHO resolutions have been adopted in this regard. WHO resolution WHA65.19 emphasized the need to establish regulations, mechanisms and collaboration to combat substandard falsely-labeled medical device products, while resolution WHA67.32 emphasized the importance of Member States having regulatory systems to regulate medical devices throughout their life cycle.
As part of the ongoing collaboration between WHO and Oman's Ministry of Health, a WHO expert on medical devices regulation, Professor Nazeeh Alothmany of King Abdulaziz University, Saudi Arabia, visited Oman on a mission to work with the division of medical devices within the Directorate of Pharmaceutical Regulations at Oman's Ministry of Health. The main objective of the mission was to share knowledge on the challenges and importance of medical device regulation, and to provide technical advice on the development of regulations in Oman.
During the mission, from 4 to 8 November 2018, meetings were held with Ministry of Health officials, and private and public sector stakeholders, to explain the importance of medical devices regulation. The visit concluded with a workshop held on the 7 November under the auspices of H.E. Dr. Mohammed bin Saif Al Hosni, Undersecretary for Health Affairs, Ministry of Health of Oman, with the attendance of Dr Akjemal Magtymova, WHO Representative to Oman, Dr Mohammed Al-Rabea, General-Director for Pharmaceutical Regulations, other officials, partners and biomedical engineers.
The proposed new medical devices regulation was presented along with exampleas of medical devices regulation from around the world. The elements in the regulation of the life cycle of a medical device were introduced, and cases of counterfeited products, medical device adverse events and poor medical device manufacturing practices were presented to show the importance of establishing a regulatory framework to assure the safety and efficacy of medical devices entering the country. Additional examples were presented to show how a good device can become dangerous if misused by an untrained individual. The workshop was well attended by more than 120 participants from different institutions and government organizations, with the audience engaging in lively discussion on the issue.
The visit concluded with a meeting with H.E. Minister of Health Dr Ahmed Mohammed Al Saidi to share the mission's recommendations. The Minister commended the mission and underlined his support for further allocation of resources and continued collaboration with WHO to further the medical devices regulation agenda.
