How ANVISA’s role at the WHO influences the regulation of medical devices in Brazil

The recent appointment of ANVISA as Brazil’s official representative on the Executive Board of the World Health Organization (WHO) has important implications for the regulation of medical devices in the country. With a strong technical performance, the Brazilian agency reinforces its international role, directly impacting the regulatory processes conducted by ANVISA.

QR Group, a specialist in health regulation, explains how this participation further strengthens national standards and what this represents for international manufacturers who want to operate in Brazil.

What does ANVISA’s entry into the WHO Executive Board mean?

ANVISA’s election to the WHO board represents a recognition of its high regulatory standard and its technical contribution to global health decisions. The WHO Executive Board is responsible for defining strategic guidelines and international health policies, with representatives from only 34 member countries.

This move reinforces Brazil’s regulatory alignment with international standards, increasing the rigor, predictability, and reliability of the evaluation processes of medical devices, such as health devices and technologies.

Impacts for Medical Device Manufacturers

ANVISA’s role in the WHO implies, among other points, in:

• Faster adoption of international guidelines, such as those of the International Medical Device Regulators Forum (IMDRF);

• Strengthening of regulatory equivalence between Brazil and other countries;

• Greater technical requirements in regulatory dossiers to ensure safety, efficacy and quality;

• Increased global visibility of the processes conducted by ANVISA, increasing international confidence in Brazilian registrations.

For international manufacturers seeking to insert their products in the domestic market, this new position of ANVISA brings both opportunities and challenges, requiring an increasingly technical, detailed and robust regulatory process.

How QR Group supports its customers in the face of this new scenario

QR Group acts as a bridge between global manufacturers and the demanding Brazilian market, offering:

• Specialized and up-to-date regulatory advice based on WHO and ANVISA guidelines;

• Technical mapping of risks and specific requirements for each product category;

• Personalized ANVISA petitioning strategies with a focus on speed and security;

• Multidisciplinary team with international experience and mastery of Brazilian legislation.

In the face of an increasingly sophisticated regulatory scenario, QR Group guarantees practical solutions, regulatory compliance and faster access to the Brazilian market — without giving up the safety and quality of the products.

ANVISA’s appointment to the WHO Executive Board reinforces the agency’s international relevance and signals the continuous strengthening of regulatory processes in Brazil. For medical device manufacturers, complying with these guidelines is essential to ensure competitiveness and permanence in the domestic market.

Are you an international manufacturer and need to ensure regulatory compliance with ANVISA?
Contact QR Group and find out how we can accelerate your entry into the Brazilian market with security and technical excellence.

Source: ANVISA