Brazil’s Medical Device Regulator ANVISA Announces Clinical Investigation Database

By Luiz Levy and Evangeline Loh

As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.

Background on clinical investigations in Brazil

Some medical devices are exempt from ANVISA approval of the study (RDC 837/2023, Article 2 (§ 1º)), including Class  I and II medical devices, IVD clinical performance studies, devices already registered with ANVISA and used with the same indications and usability studies.

Clinical investigations with Class III and IV medical devices must be reviewed and authorized by ANVISA.

Initiatives are aligned with ANVISA’s digital transformation objectives

ANVISA has worked diligently to provide more information and transparency of its activities.

As part of this, ANVISA announced (December 19) the launch of a clinical investigation database.

ANVISA clinical investigation database

The ANVISA clinical investigation database provides information (in Portuguese) about the clinical investigations that ANVISA has authorized in Brazil. The database is based on a Microsoft PowerBI platform (business intelligence dashboard).

There are “buttons” that allow the user to filter by the category of medical device, material or equipment and the year. In addition, it is also possible to filter between clinical investigations that have been cleared, cleared with clinical investigation completed or cleared with Investigation started.

Preliminary clinical investigation data

Information is provided about the type of investigation, the investigational medical device, indications for use/purpose, title of the investigation as well as the sponsor.

While there is an option to filter between material and equipment, there was actually only one equipment clinical investigation, which commenced in 2022. In addition, only data from the past nine years (to 2016) was posted.

Concluding remarks

This clinical investigational data on Brazil is welcome and coincides with the release of clinical investigational data in Europe. In Europe, Clinical Investigation Reports (CIR) have been posted to the European CIRCABC (November 30).

In addition, as we recently wrote, Health Canada makes clinical information available on Class III and Class IV medical devices (Public Release of Clinical Information).

Regulators recognize the importance of publicizing this clinical investigational data.