In July 2025, Mexico’s Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published new guidelines establishing an abbreviated regulatory pathway for the registration of medicines and medical devices. One of the most significant developments is the recognition of Brazil’s National Health Surveillance Agency (ANVISA) as a National Regulatory Authorities of Regional Reference (RNAr)

This means that marketing authorizations and inspections conducted by ANVISA may now be accepted in Mexico, provided they meet the technical criteria set by COFEPRIS.

This recognition should not be seen merely as a diplomatic gesture. It reflects a technical endorsement of ANVISA’s regulatory processes, particularly its ability to ensure the safety, efficacy, and quality of health products.

The Concept of Reliance

The World Health Organization defines reliance as the process by which a regulatory authority uses the assessments performed by another trusted authority as part of its own decision-making. Even when applying this model, the local authority retains full responsibility for the final decision.

Mutual trust requires reciprocal confidence, but also clear criteria, transparency, and accountability. When implemented properly, it can reduce duplication of effort and accelerate access to health technologies, facilitating the entry of Brazilian products into the Mexican market in a more agile and efficient manner.

Reliance, Recognition, and Work-Sharing

These three regulatory approaches are often confused but have distinct meanings:

• Reliance: partial or full use of another authority’s assessments, with the final decision remaining local
• Recognition: full acceptance of another authority’s decision, with no further evaluation
• Work-sharing: simultaneous collaboration between authorities on joint assessments

Understanding these distinctions is essential to accurately interpret the scope of COFEPRIS’s new guidelines.

What COFEPRIS Has Established

The guidelines, published in Mexico’s Official Gazette, allow the country to recognize the requirements, testing, and evaluation procedures of authorities such as the FDA (USA), EMA (EU), Swissmedic (Switzerland), Health Canada, TGA (Australia), and now ANVISA (Brazil) as equivalent.

This enables Brazilian companies with ANVISA-approved registrations to use those approvals as the basis for seeking registration in Mexico via the abbreviated pathway. The same applies to inspections conducted by ANVISA at medical device manufacturing sites.

Opportunities for Industry

This decision offers a significant competitive advantage for Brazilian companies by reducing the time and costs associated with entering the Mexican market. With COFEPRIS’ recognition of ANVISA’s evaluations, Brazilian companies can take advantage of prior product approvals, facilitating their registration in Mexico through an abbreviated regulatory pathway.

If applied rigorously, reliance can benefit the public by facilitating faster access to safe and effective health technologies. However, this benefit depends on maintaining high standards of quality and regulatory oversight.

COFEPRIS’s recognition of ANVISA marks a significant step toward regulatory convergence in Latin America. It presents a concrete opportunity for industry, a test of maturity for regulatory systems, and a validation of Brazil’s regulatory model—provided that Brazil continues to invest in quality, transparency, and international cooperation.

If your company operates in the medical device sector and is considering expansion into the Mexican market, now is the time to review your regulatory strategy and assess how the abbreviated pathway can be applied safely and effectively to your business.

COFEPRIS’ recognition of ANVISA marks an important step towards regulatory convergence in Latin America. For Brazilian companies, this not only represents an opportunity to access the Mexican market more quickly, but also a validation of Brazil’s regulatory model in the international context. Brazilian companies should take advantage of this opportunity to review their regulatory strategies and assess how this simplified process can accelerate their entry into Mexico, reducing time and costs in the registration process.