Brazil ANVISA 2025 Regulation on Saline Solution Reclassification

The Brazilian Health Regulatory Agency (ANVISA) has officially approved a 2025 regulation for the sanitary classification of saline solutions used for nasal irrigation — including 0.9% sodium-chloride and powdered formulations — as Class IV medical devices. The decision, published on October 30 2025, establishes a clear legal framework for these products and sets a compliance deadline of May 30 2026 for companies to complete reclassification from medicines to medical devices.

Key Updates from ANVISA’s 2025 Regulation

Approved by ANVISA’s Collegiate Board (DICOL) on October 29 2025, this new Collegiate Board Resolution (RDC) formalizes earlier internal decisions (Vote No. 128/2023/SEI/DIRE3/ANVISA) that had already reclassified saline products in principle but lacked an official regulatory instrument.

The new resolution now:

• Confers legal validity to the reclassification, ensuring predictability and transparency.

• Defines the sanitary framework for sodium-chloride nasal irrigation products under RDC 751/2022 (or updates).

• Classifies these products as Class IV medical devices, the highest medical device risk class in Brazil.

Transition Rules and Deadlines

The regulation introduces specific transition provisions that were previously undefined, including:

1. Adaptation deadlines: Manufacturers must reclassify affected products by May 30 2026, as per RDC 576/2021.

2. Stock depletion conditions: Rules are set for using existing packaging, labeling, and instructions during the transition.

3. Batch marketing criteria: Defines how products manufactured before full implementation can be marketed until stocks are exhausted.

4. Automatic cancellation: After the deadline, any notifications still filed as medicines will be automatically cancelled by ANVISA.

Use of GMP Certification Simplifies Compliance

A key advancement is the acceptance of Good Manufacturing Practice (GMP) certification for saline solutions now classified as medical devices. Director Daniela Marreco, rapporteur for the matter, highlighted that GMP standards applicable to both health products and medicines are sufficient to guarantee safety and quality. This change removes a significant barrier for manufacturers and aligns requirements with broader international norms.

Impact on the Regulated Sector

This regulatory update provides:

• Legal certainty for companies operating in Brazil’s health-product market.

• Clearer classification criteria for sodium-chloride-based solutions.

• Alignment with global medical-device frameworks such as the IMDRF and ISO 13485.

For the production sector, it streamlines compliance, enabling companies already compliant with pharmaceutical GMP to transition smoothly without redundant audits.

How Companies Should Prepare

To ensure timely compliance, ANVISA recommends that manufacturers and distributors:

1. Identify affected SKUs registered as medicines.

2. Plan reclassification under the Class IV medical device pathway.

3. Update technical documentation and labeling to meet RDC 751/2022 requirements.

4. Maintain GMP certification to benefit from simplified approval.

5. Monitor ANVISA communications for additional guidance during the transition period.

Official Source and Further Reading

For the full text and official updates, visit:
ANVISA Official Website – gov.br/anvisa

Related resources:

• Brazil ANVISA Medical Device Classification

• Brazil ANVISA Medical Device Registration Process