Question 1

What is ANVISA and why is it important for medical device companies?

Accepted Answer

ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's health regulatory agency, equivalent to the FDA in the United States. It regulates medical devices, IVDs, pharmaceuticals, and other health products in Brazil's $7.3 billion medical device market. All medical device companies must obtain ANVISA approval and maintain compliance with RDC regulations to sell products in Brazil.

Question 2

What are the most important RDC regulations for medical devices?

Accepted Answer

Key RDC regulations include: RDC 751/2022 (medical device classification and registration), RDC 830/2023 (IVD device regulation), RDC 591/2021 (UDI requirements), RDC 982/2025 (risk-based manufacturing practices), and RDC 665/2022 (Good Manufacturing Practices). This page tracks all major RDC updates from premium regulatory intelligence sources.

Question 3

What is Brazil's UDI system (SIUD) and when does it take effect?

Accepted Answer

SIUD (Sistema de Identificação Única de Dispositivos Médicos) is Brazil's national UDI system launched in July 2025. Established by RDC 591/2021, it requires manufacturers to register devices in the SIUD database and apply standardized UDI labels. This aligns Brazil with global UDI standards (FDA, EU MDR) for improved device traceability and patient safety.

Question 4

How often does ANVISA publish new regulations and updates?

Accepted Answer

ANVISA publishes RDC regulations and updates regularly throughout the year, with major regulatory packages typically announced during annual priority planning periods. This page aggregates ANVISA news from 7 premium commercial sources including RAPS, Pacific Bridge Medical, Emergo by UL, and Citeline, providing daily updates on regulatory changes, public consultations, and enforcement actions.

Question 5

What is a Brazilian Registration Holder (BRH) and do I need one?

Accepted Answer

A Brazilian Registration Holder (BRH) is a legal entity in Brazil required for foreign medical device manufacturers without a physical presence in Brazil. The BRH acts as the legal representative for ANVISA registration, post-market surveillance, and compliance activities. All foreign companies must appoint a BRH to register and sell medical devices in Brazil. Learn more in our BRH selection guide.

Question 6

How can I stay updated on ANVISA regulatory changes?

Accepted Answer

This page automatically aggregates ANVISA news from 7 premium regulatory intelligence sources daily. You can also use our free ANVISA Device Classifier tool which includes analysis of official ANVISA documents and regulations. Pure Global provides comprehensive regulatory support for Brazil market access.

Question 7

What sources does this ANVISA news page aggregate from?

Accepted Answer

We aggregate Brazil and ANVISA news from 7 premium commercial regulatory intelligence sources: RAPS (Regulatory Affairs Professionals Society), Pacific Bridge Medical, Emergo by UL, Asia Actual, Citeline MedTech Insight, Pure Global's proprietary Brazil research team, and Qualtechs. All sources are filtered to show only Brazil-related regulatory updates using advanced keyword matching.

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