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ABIMED features in a international regulators’ forum

Publicado em 04/05/2023 • Notícias • Português

On March 27th and 28th, the IMDRF 23 (International Medical Device Regulators) took place in Brussels (Belgium), , with ABIMED taking part. Established in 2011, the IMDRF is a forum of medical device regulators from various countries who work together for international regulatory harmonization and convergence.

On the first day of the event, a workshop was held, led by IMDRF and two organizations of which ABIMED is a member: DITTA (Global Diagnostic Imaging, Healthcare It & Radiation Therapy Trade Association) and GMTA (Global Medical Technology Alliance). With the theme “Life cycle of medical devices: the importance of post-marketing related activities”, improvement opportunities and challenges in Safety Notifications and Surveillance were discussed from the perspectives of regulators, industry, and healthcare professionals.

On the second day, it was time for the IMDRF Stakeholder Forum with regulatory updates from the IMDRF Management Committee and Official Observers (World Health Organization and Argentina); evaluation of the progress of IMDRF work items and the Stakeholders Session with presentations from the: African Medical Devices Forum, Global Harmonization Working Party, Asia-Pacific Economic Cooperation, PAHO (Pan American Health Organization), DITTA and GMTA.

It is important to note that the IMDRF Management Committee includes representatives of the European Commission and representatives of the EU Member States, along with Australia, Brazil, Canada, China, Japan, Singapore, South Korea, and the USA. The forum produces guidance documents aimed at simplifying the work of regulators and economic operators globally.

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