Biomerica Earns Brazilian Approval for Several Clinical Lab Products

Irvine, Calif.-based Biomerica Inc. has received its first Brazilian ANVISA approvals for several of its clinical lab products. ANVISA is Brazil’s equivalent to the U.S. Food and Drug Administration and is responsible for the oversight of all pharmaceuticals and medical devices in the Brazilian market. The approved products will be distributed through a new Brazilian distribution partner. Several other Biomerica product approvals are pending.

With a population of over 200 million people, Brazil is South America’s largest market for in vitro diagnostic products. It represents Biomerica’s first major push into the Latin American market and, according to company officials, should provide the impetus to further penetration of the South American continent.

“We are pleased to receive our first approvals for products in Brazil,” said Zackary Irani, Biomerica’s CEO. “This represents a breakthrough for the company in what should be a very lucrative market for our products. Brazil is the world’s ninth largest economy, as well as one of the world’s fastest growing medical device markets,”

Biomerica makes diagnostic products used at the point-of-care and in hospital/clinical laboratories for the early detection of medical conditions and diseases.