Systems, Kits & Procedure Packs
A system or kit combines two or more medical devices and/or IVDs sold as a single unit with a single instruction for use. Each component device must be individually registered with ANVISA before the system can be registered. A separate system registration is required only if: (1) the combination creates a new intended use not covered by individual component registrations, (2) the combination alters the safety or performance characteristics of individual components (e.g., through electromagnetic interactions), or (3) ANVISA determines that the system combination requires dedicated safety and performance data.
The system's packaging and labelling must clearly identify all components and their individual ANVISA registration numbers.
Verify all information against official ANVISA sources before making regulatory decisions.