Nov 3, 2014
Brazilian medical device market regulator ANVISA has begun allowing automatic extensions for deadlines for market registrants to comply with new requirements issued by the regulator.
ANVISA’s new service order (OS 002/2014 (GGTPS)) will automatically add 60-day extensions for 30-day deadlines to meet requirements set forth by Brazilian regulators in cases where firms need more time to comply. Currently, firms and registrants must file deadline extension applications with ANVISA in order to be granted more time to comply with new requirements.
The new process will be applied to all orders and requirements issued by ANVISA’s GGTPS office for managing health technology products going forward. According to the regulator, implementing the new deadline extension is intended to provide more efficiencies to ANVISA’s processes overseeing Brazil’s medical device sector.
New regulations were recently enacted by Brazil's National Health Surveillance Agency (ANVISA).
Brazil’s National Agency for Sanitary Surveillance (ANVISA) will purportedly begin charging inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) every two years rather than on an annual basis.