The Brazilian Health Regulatory Agency (ANVISA) enabled the import of reconditioned medical devices and used medical devices destined for reconditioning in Brazil under specific conditions. Rules for the commercialization and donation of used or reconditioned medical devices were also enacted.
RDC Resolution n.º 579/2021 from the Brazilian Health Regulatory Agency (ANVISA) revoked RDC Resolution n.º 225/2001 in order to enable the import, commercialization, and donation of used or reconditioned medical devices, specifically medical devices regulated by RDC Resolutions n.º 185/2001 and n.º 36/2015, destined for use in Brazil.
According to ANVISA, the new resolution maintained the general prohibition on the import, commercialization, and donation of used or reconditioned medical devices (article 4), but allowed flexibility for specific products under specific conditions. Among those, it enabled the import of reconditioned medical devices – i.e., equipment or instruments for in vitro diagnosis that undergo an industrial reconditioning process (e.g., to repair or replace parts) by the original producer or their corporate group, or by companies qualified by the original producer to carry the required industrial processes (see article 3 for definitions).
According to article 15, reconditioned medical devices with valid product registration within ANVISA may be imported. Articles 16 to 18 provided specific conditions for reconditioned medical devices. Additionally, according to article 4, the import of used medical devices (equipment or instruments for in vitro diagnosis) is only allowed when destined for reconditioning in Brazil, in line with RDC Resolution n.º 81/2008.
Conditions related to used medical devices are provided in articles 6 to 14.
