Brazilian Regulators Allow More Flexibility for Device Registration Transfers, Extend Tech File Deadline
Brazilian medical device market regulator ANVISA has signaled that a new regulation providing more flexibility for transferring medical device registrations between holders.
At a recent ANVISA meeting attended by Emergo consultants, the agency announced that agreement on the final contents of the new device ownership transfer rule has been reached; Emergo expects the new rule to be officially published in August or September 2016, at which point further details regarding transfer requirements and fees will be available.
In addition, ANVISA announced at the meeting that it has extended its deadline for compiling technical dossiers for lower-risk cadastro device registrations. The deadline had originally been set for August 26, 2016, but now the regulator plans to allow two years from the official date of publication of these modified requirements for medical device manufacturers to comply, and three years from that publication date for IVD manufacturers.
As Emergo reported in August 2015, Brazilian regulators announced new technical dossier requirements last year for cadastro devices whose manufacturers had previously not had to maintain such documentation. The initial 360-day deadline for compliance was apparently inadequate for affected ANVISA registrants to prepare for the new requirements.
It should be noted that until ANVISA publishes official changes to its registration transfer and cadastro technical dossier deadline rules, current requirements for these processes remain in place.