In a step toward consolidating regulatory reliance, The Brazil Health Regulatory Agency (ANVISA) said on 8 April that it would recognize decisions by regulators in the United States, Japan, European Union, and Australia to register certain medical devices. The policy, which takes effect on 3 June, will shorten analysis times and lead to faster registrations, ANVISA said. Applicants must demonstrate that any product destined for the Brazilian market has “the same production characteristics, indications and intended use” as a product submitted to the foreign regulatory agency whose decision will be referenced.
In recent years ANVISA, one of the founding members of the International Medical Device Regulators Forum (IMDRF), has been updating its device rules and working toward greater alignment with other major global agencies. The new device reliance measures come after a public consultation process opened by ANVISA last fall on the use of analyses by the same foreign authorities. While ANVISA did not say in its 8 April statement which device classes would be covered by the new rule, the public consultation covered risk classes 3 and 4 as well as in vitro diagnostic devices…
