Since the publication of MEDDEV 2.7/1 rev4 and the Medical Devices Regulation (MDR), clinical data is under heavy scrutiny by Notified Bodies and Competent Authorities...
ANVISA Allowing Automatic Deadline Extensions for Medical Device Registrants
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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.
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