Mandatory requirements for additional product information  for medical devices (MDs) and in vitro diagnostic medical devices (IVDs) have exponentially increased recently. Under the current legislative system in the EU, both essential information (information needed...

The regularization of medical equipment and software as a medical device at ANVISA is a crucial process for ensuring safety and efficacy in healthcare technology. The Management of Medical Equipment Technology, known as GQUIP, plays a vital role in this regulation....

The FDA just issued final revised guidance explaining how sponsors can get preliminary, non-binding FDA feedback on a product’s regulatory identity (drug, device, biologic, or combination) and Center assignment (CDER, CDRH, or CBER). It replaces the Feb 2018 version...

Nesta semana decorreu mais uma edição da formação exclusiva da Formiventos CTD MODULO 3, bajo o lema : Uma revisão exaustiva de todos os pontos críticos a considerar para  garantir o cumprimento dos requisitos regulamentares e  atingir  os melhores prazos de resposta...