Systems, Kits & Procedure Packs

A system or kit combines medical devices and/or IVDs sold as a single unit. Each component device must be individually registered with ANVISA. A separate system registration is required only if the combination creates a new intended use or alters the safety/performance characteristics of the individual components.

The system's packaging and labelling must clearly identify all components and their individual ANVISA registration numbers.

---

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.