Brazil Siscomex 2025: What Medical Device Importers Must Know

Brazil’s Siscomex system has announced changes under Import Announcement No. 070/2025, introducing updates to the Product Catalog attributes as part of the New Import Process (NPI). These changes are crucial for companies importing into Brazil—especially medical device manufacturers, who must align product descriptions and regulatory data to avoid clearance delays and ensure full compliance with ANVISA and related authorities.

What Is the Siscomex Product Catalog?

The Siscomex Product Catalog is a centralized, structured data system created for each importing company, linked to its Brazilian taxpayer ID (CNPJ). It captures detailed product information based on the applicable NCM (Mercosur Common Nomenclature) code.

Each imported item must be described using predefined attributes—such as brand, model, application, technical specs, and packaging details—specified by the Brazilian customs authority. The objective is to create a standardized, digital import environment, consistent with the World Customs Organization’s single trade window framework.

Key Changes in Import Announcement No. 070/2025

Published on July 23, 2025, Import Announcement No. 070/2025 outlines updates to the Product Catalog that will impact how import data is submitted and processed. These focuses on:

• Harmonizing information across import declarations

• Meeting the data requirements of consenting bodies (e.g., ANVISA, INMETRO)

• Improving the consistency and traceability of goods through updated product classification attributes

These attribute changes go into effect on the dates listed in the official implementation spreadsheet (check the "Implementation Date" column for each item).

Why This Matters to Medical Device Importers

As medical devices fall under the jurisdiction of ANVISA, any information submitted via Siscomex must be consistent with ANVISA registration or certification documents.

Failure to comply may result in:

• Customs clearance delays or refusals

• Additional review by ANVISA or Receita Federal

• Penalties for misclassification or missing product details

These updates reinforce the importance of maintaining accurate, harmonized product data across customs and regulatory platforms.

How to Prepare for the 2026 Deadline

To stay ahead of the regulatory transition, medical device companies should take proactive steps now:

1. Map all imported devices to their correct NCM codes

2. Identify and complete mandatory product attributes using Siscomex guidelines

3. Ensure consistency with ANVISA registration data

4. Appoint an experienced Importer of Record (IoR) if you don’t have a legal presence in Brazil

5. Use the Siscomex training environment to test catalog entries before the official launch

At Pure Global, we support MedTech companies by acting as the Importer of Record and in-country representative, ensuring that all Siscomex and ANVISA requirements are met for a smooth market entry.

Related Resources

• Pure Global- ANVISA Brazil Medical Device Registration

• Pure Global - ANVISA Brazil Medical Device Regulations

• Pure Global - ANVISA Brazil Medical Device & IVD Classification & Grouping

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