Market Intelligence
Medical Devices Brazil

Brazil Clinical Medical Tests at Drugstores

In May 2023, Brazil’s National Health Surveillance Agency (Anvisa) published regulation RDC No. 786, updating technical sanitary requirements for the operation of clinical laboratories. The purpose of the new regulation is to increase people’s access to rapid and point-of-care clinical tests. This new regulation opens a new sales channel for manufacturers of several different clinical tests that can now be performed at pharmacies and clinics.  

U.S. exporters looking to sell their clinical tests to Brazilian clients must register their products at Anvisa through a local Brazilian importer or distributor. The new regulation entered into force on August 1, 2023.  

For more information about the types of tests included in the regulation, how to register products with Anvisa, and guidance on how to do business in the healthcare sector in Brazil please contact:
Jefferson Oliveira
Senior Commercial Specialist
U.S. Commercial Service – Brazil