The Brazilian healthcare industry has 18 months to prepare for a radical overhaul of the operational "management" and regulatory oversight of medical equipment and supplies.

All types of healthcare facility and support service are affected – from hospitals and "diagnostic support" services to home care – as are non-medtech products, including medicines, cosmetics and hygiene products.

Resolution RDC 2/2010, published in the Diário Oficial da União (DOU) of January 26, will require service providers to establish "a series of management and planning procedures that take into consideration the quality, efficacy, effectiveness, safety and traceability of products, from their delivery to their disposal", according to regulatory agency Anvisa.

The Resolution will also enforce new obligations regarding the reporting, on the part of healthcare and support service providers, of adverse events and technical faults.

Further details of these requirements and of their practical implications – such as product labelling – are to be set out in a forthcoming "medical technologies management guide" (Guia de Gerenciamento de Tecnologias em Saúde). This is being produced by Anvisa and is due to be completed "within the next six months".