Date: November 3, 2025
The ANVISA has approved a new regulation classifying sodium chloride-based products intended for nasal irrigation as medical devices.
The decision was approved by ANVISA’s Collegiate Board (Dicol) on October 29, 2025 and formalized through a new Collegiate Board Resolution (RDC), granting the measure full regulatory and normative effect.
What does the new regulation establish ?
The regulation applies to:
- Sodium chloride 0.9% solutions for nasal irrigation
- Powdered sodium chloride products intended for preparation
These products are now explicitly classified as Class IV risk medical devices, in accordance with RDC 751/2022 (or its updates)
This clarification provides greater legal certainty and regulatory predictability for manufacturers and distributors operating in Brazil.
Transition Rules for Companies
The new RDC introduces structured transition provisions, including:
- Defined deadlines for regulatory adaptation
- Rules for depletion of packaging, labeling, and IFU stocks
- Criteria for commercialization of batches produced during the transition period
GMP flexibility
An important regulatory improvement is the possibility of using Good Manufacturing Practices (GMP) certification for these products. According to Director Daniela Marreco, rapporteur of the matter:
“The Good Manufacturing Practices requirements, both for health products and for medicines, are sufficient to guarantee the quality and safety of these products.”
Under RDC 576/2021, companies have until May 30, 2026 to:
- Cancel existing notifications as medicines
- Register the products as medical devices
After this deadline, any remaining medicine notifications will be automatically canceled by ANVISA.