QR Group analyzes the impact of agency performance for companies seeking registration of health products in Brazil

ANVISA was rated 10 in the OECD Index of Good Regulatory Practices, according to a report released in April 2024. The index, prepared by the Organization for Economic Cooperation and Development, measures the quality of standard-making processes in member and partner countries.

This international recognition strengthens the credibility of the Brazilian regulatory system and has direct implications for companies that wish to register or regularize health products in Brazil. QR Group, a specialist in regulatory consulting, analyzes what this performance represents in practice for the productive sector.

What does the Good Regulatory Practice Index mean?

The index evaluates three main pillars:

• Transparency in regulatory processes,

• Technical basis in decision-making,

• Ability to analyze regulatory impact.

The maximum score achieved by ANVISA reflects the agency’s commitment to robust regulatory governance, continuous regulatory updating, and alignment with international standards — such as those required by the IMDRF (International Medical Device Regulators Forum) and the WHO.

This reinforces ANVISA’s image as one of the most technical and reliable health authorities in the world.

Impacts for companies seeking to regularize products in Brazil

The improvement in ANVISA’s performance has practical effects on the day-to-day life of companies that operate or wish to enter the Brazilian health products market:

• Greater regulatory predictability in the petitioning and technical analysis processes;

• More structured, transparent and evidence-based processes;

• Greater international credibility for products registered in Brazil;

• Reduction of risks in audits and inspections, especially for exporting companies.

These factors increase the competitiveness of companies that maintain regulatory compliance and follow good practices from the beginning of the process.

How QR Group helps your company act with regulatory excellence

With extensive experience in the regulatory sector, QR Group offers complete solutions for companies that wish to register, import or manufacture health products in Brazil, maintaining alignment with the high standards required by ANVISA:

• Strategic regulatory consulting, with a focus on risk mitigation;

• Development of technical and clinical dossiers with high documentary quality;

• Management of regulatory processes with traceability and transparency;

• Dialogue with ANVISA’s technical areas and continuous regulatory updating.

Our commitment is to transform regulatory requirements into market differentials for our customers.

Talk to QR Group

Does your company need to register health products in Brazil with security and high regulatory performance?
QR Group is ready to support you with technical excellence and agility. Contact us and talk to us.

Source: QR Group