Changes to regulations in Brazil are making room for major progress in easing medical device registration for high-risk devices. Currently, Brazil has the 7th
largest economy in the world and the largest medical device market in South America, which is valued at USD $5,981.9 million and expected to reach USD $8 billion in revenue this year.
Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária
or ANVISA) has two tracks for medical device registration: cadastro
. The cadastro
process is implemented for lower-risk devices, under which most Class I and II products are registered (excepting a published list of specific device types), and registration is usually completed within four to six months. Device registered via registro
typically belong to higher-risk classes and regulatory approval can take as long as 24-30 months to obtain. While there are many attractions to the Brazilian market, medical device manufacturers with products that must go through the registro
system have faced sometimes-insurmountable challenges when attempting to obtain...