Brasília – The National Health Surveillance Agency (Anvisa) has approved a new regulation that reclassifies saline solutions — chloride-based products used for nasal irrigation — from medicines to class IV medical devices. The rule applies to both powder formulations and 0.9% saline solutions.

The measure formalizes a decision first announced in 2023 and sets May 30, 2026, as the deadline for companies to cancel existing medicine registrations and reapply under the new medical device framework. It also establishes transitional provisions, allowing the continued use of current Good Manufacturing Practices (GMP) certificates for medicines during the adaptation period.

According to Anvisa, the new classification provides regulatory clarity and predictability for manufacturers and distributors while aligning Brazil’s approach with international standards for medical device oversight.

Source: Anvisa

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