www.fdanews.com/articles/126212-brazil-implements-new-requirements-making-device-registration-tougher
Brazil Implements New Requirements, Making Device Registration Tougher
April 14, 2010
Devicemakers are concerned that a May 24 deadline for good manufacturing practice inspections of facilities seeking to register
or reregister in Brazil could cause major disruptions in supplies to the Brazilian market. The regulation requires all local and foreign device companies
that are registering or reregistering a product to undergo an on-site audit before entering the market.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor