Brazil's New Import Model Takes Effect: What ANVISA's DUIMP Transition Means for Medical Device Companies

What's Changed?

On 12 June 2026, Brazil's National Health Surveillance Agency (ANVISA) announced additional support measures as the country transitions to the Declaração Única de Importação (DUIMP), Brazil's new Single Import Declaration system. Since 27 April 2026, DUIMP has become mandatory for many import operations requiring ANVISA authorisation, replacing the previous Import Licence (LI) and Import Declaration (DI) processes. The new model centralises customs, fiscal, commercial, and logistics information through Brazil's Single Foreign Trade Portal.

While the regulatory objective is to simplify and modernise import procedures, ANVISA emphasised that the quality and accuracy of submitted information will play a critical role in ensuring efficient processing during this transition.

Why This Change Matters

For medical device manufacturers and importers, import procedures are an essential component of market access.

The implementation of DUIMP represents more than a digital system upgrade; it introduces a new way of managing regulatory interactions across Brazil's import process.

Companies that fail to adapt their documentation, internal workflows, and submission practices may experience delays, while those that prepare early are more likely to benefit from a smoother regulatory process.

Who Needs to Pay Attention?

This regulatory change is particularly relevant for:

✔ Medical device manufacturers

✔ Importers and distributors

✔ Authorised representatives

✔ Regulatory affairs professionals

✔ Supply chain and logistics teams

✔ Companies planning market entry into Brazil

Organisations relying on imported healthcare products should review how the new import model may affect day-to-day regulatory operations.

What Companies Should Do Next

1. Review Import Workflows

Assess whether current import procedures align with the DUIMP process and identify any operational gaps.

2. Strengthen Documentation Quality

ANVISA has highlighted that complete and accurate information is essential for efficient processing. Companies should ensure documentation is reviewed before submission.

3. Coordinate Regulatory and Logistics Teams

Successful implementation requires close collaboration between regulatory affairs, customs brokers, logistics providers, and commercial teams.

4. Monitor Additional Guidance

As implementation continues, companies should remain alert to further operational guidance or support measures issued by ANVISA.

ARQon Insight

Digital transformation is reshaping healthcare regulation around the world, and import procedures are no exception.

Brazil's transition to DUIMP demonstrates that regulatory modernisation is increasingly focused on creating integrated, data-driven processes rather than simply replacing paper-based systems.

For companies operating internationally, regulatory readiness now extends beyond product registration. It also requires robust documentation practices, cross-functional collaboration, and adaptable operational processes.

🌍 Global Regulatory Trend

Brazil is not alone in modernising regulatory operations.

Across global healthcare markets, regulators are investing in digital systems to improve efficiency, transparency, and oversight. Similar modernisation initiatives have been observed in countries such as the Philippines, Canada, and Singapore, reflecting a broader international shift toward digital regulatory ecosystems.

Manufacturers with globally harmonised regulatory processes will be better positioned to navigate these evolving requirements across multiple markets.

Key Takeaway

Brazil's adoption of DUIMP marks an important milestone in the modernisation of import procedures for regulated healthcare products.

For medical device companies, early preparation, accurate documentation, and coordinated regulatory planning will be essential to maintaining efficient market access as the new system becomes fully embedded.

How ARQon Can Support

ARQon helps healthcare and life sciences companies navigate regulatory change through:

• Regulatory intelligence and monitoring

• Brazil market access strategy

• Medical device regulatory consulting

• Import and compliance planning

• Global regulatory support

• Cross-border market expansion

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.