MOH and WHO conducted medical devices registration guideline consensus building workshop at National Confederation of Eritrean Workers' Conference Hall in June 2019. Medical devices including In-Vitro Diagnostics (IVD) constitute a vital component of healthcare products and healthcare technologies that contribute to the attainment of the highest standards of health for all people living in Eritrea. To ensure safety, quality and conformity of these medical products, strict regulation at all levels is important
The guideline is primarily developed to support applicants in complete and appropriate submission of the product dossiers, to the National Medicines and Food Administration unit (NMFA) prior to any procurement process. The guideline is also intended to support all stakeholders to appropriately monitor the safety, performance and conformity of medical devices including In-Vitro Diagnostics according to their level of risk. As incomplete submissions and untimely response to queries results in unnecessary delays to the registration process, applicants are reminded to strictly follow the requirements outlined in the guideline.
The workshop was officially opened by the Director General of Medical Services, Mr Berhane Gebretnsae, who highlighted that one of the World Health Assembly resolution was on 'WHO global model regulatory framework for Medical Devices including IVDs', inviting all member states to develop regulatory frameworks for medical devices. He added that in order to keep abreast with the above resolution, this guidance document is adopted from the Global Harmonization Task Force and is drawn into the Eritrean context.
Mr Iyasu Bahta, director of the National Medicines and Food Administration unit addressed the participants that medical devices are an integral part of the healthcare delivery system and it is also well noted that these devices carry a degree of risk that could cause problems in certain circumstances. Therefore, from a regulatory perspective, it is important to understand that it is not only accessibility but also safety and performance of medical devices that count, he added.
The government of Eritrea, has identified and prioritized the fast tracking for the development of policies, regulatory framework for medical devices guidance documents to streamline the procurement, access of medical devices which will go towards the improvement of health service delivery, whilst creating an enabling environment for involvement of stakeholders, policy makers and government input.