ANVISA Recognized as a WHO Transitional Listed Authority for Medical Devices

The World Health Organization (WHO) has included Brazil’s National Health Surveillance Agency (ANVISA) in its first list of Transitional WHO Listed Authorities for Medical Devices (tWLAs-MD), announced on 1 July 2026. The designation recognizes ANVISA’s regulatory oversight of medical devices and in vitro diagnostic (IVD) medical devices and marks an important milestone in WHO’s transition from the Stringent Regulatory Authorities (SRA) framework to the WHO Listed Authorities (WLA) model, supporting greater international regulatory reliance and cooperation.

Key Update: ANVISA Added to the WHO Transitional Listed Authorities (tWLAs-MD)

WHO has officially published the first Transitional WHO Listed Authorities for Medical Devices (tWLAs-MD), with ANVISA among the recognized regulatory authorities.

The transitional list is designed to facilitate the global shift from the long-established Stringent Regulatory Authorities (SRAs) framework to the more comprehensive WHO Listed Authorities (WLA) system.

Recognition under the transitional framework reflects WHO’s confidence in ANVISA’s regulatory oversight functions for:

• Medical devices
• In vitro diagnostic (IVD) medical devices
• Regulatory review and oversight activities

This milestone further strengthens Brazil’s position within the global medical device regulatory landscape.

What Is the WHO Listed Authorities (WLA) Framework?

The WHO Listed Authorities (WLA) framework is an international initiative that identifies national and regional regulatory authorities that consistently demonstrate robust regulatory systems and performance.

The WLA framework aims to:

• Promote international regulatory reliance.
• Encourage regulatory convergence.
• Improve access to safe, effective, and quality medical products.
• Reduce duplication of regulatory assessments across jurisdictions.

The publication of the tWLAs-MD represents an important transitional phase before authorities receive full WHO Listed Authority designation.

ANVISA Joins Leading Global Regulatory Authorities

With this recognition, ANVISA becomes one of 12 regulatory authorities and regional regulatory systems included in WHO’s transitional list.

Other recognized authorities include:

• U.S. Food and Drug Administration (FDA)
• Health Canada
• Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
• Therapeutic Goods Administration (TGA), Australia
• National Medical Products Administration (NMPA), China
• European Medical Devices Regulatory Network (European Union)

Being included alongside these well-established regulatory agencies highlights ANVISA’s growing role in international medical device regulation.

What Does the Transitional Designation Mean?

The tWLAs-MD designation is valid for five years.

During this transitional period, WHO will:

• Define the scope of recognition for each authority.
• Continue assessing regulatory performance.
• Support authorities in progressing toward formal WHO Listed Authority (WLA) designation.

WHO also emphasizes that national regulatory authorities, procurement organizations, and other stakeholders remain responsible for determining how the transitional list is applied within their own regulatory reliance frameworks.

In other words, inclusion on the transitional list does not automatically change regulatory requirements in other countries, but it provides an internationally recognized benchmark for regulatory capability.

Why This Matters for Medical Device Manufacturers

Recognition of ANVISA under the WHO Transitional Listed Authorities framework may provide several long-term benefits for medical device manufacturers and IVD companies operating globally.

Potential implications include:

• Increased confidence in ANVISA’s regulatory decisions.
• Greater opportunities for regulatory reliance by other jurisdictions.
• Enhanced international cooperation between regulatory authorities.
• Support for more efficient regulatory pathways over time.

Although each country will determine how it uses the WLA framework, the initiative reflects the growing trend toward international regulatory harmonization.

Conclusion

ANVISA’s inclusion in the WHO Transitional Listed Authorities for Medical Devices (tWLAs-MD) represents a significant milestone for Brazil’s regulatory system and the global medical device sector.

As WHO continues implementing the WHO Listed Authorities (WLA) framework, this recognition supports greater international collaboration, regulatory reliance, and confidence in ANVISA’s oversight of medical devices and IVDs. While the designation does not immediately alter regulatory pathways, it reinforces Brazil’s position as an internationally recognized regulatory authority and lays the foundation for future harmonization efforts.

Learn more about ANVISA Brazil medical device registration, read the ANVISA official publication, and see the WHO list of Transitional WHO Listed Authorities for Medical Devices.