The Chemical Assessment Advisory Committee (CAAC) of the Environmental Protection Agency’s Science Advisory Board (SAB) met recently to evaluate the agency’s Integrated Risk Information System (IRIS) draft assessment of the carcinogenic effects of ethylene oxide (EO). The final draft conclusion on the risks of EO could have major implications for medical device makers.
Brazil’s medical device regulatory body, the Agência Nacional de Vigilância Sanitária (ANVISA), recently announced that it will now be accepting industry feedback following Brazilian Good Manufacturing Practice (BGMP) inspections.
With a comprehensive regulatory framework for medical devices set to take effect on Nov. 25, Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has made some changes that need to be addressed for device makers looking to remain compliant in the Asian market.
A group of experts will review the Australian Therapeutic Goods Administration’s (TGA) framework for the regulation of medical devices and pharmaceuticals, according to a recent government announcement.