ANVISA REGISTRATION HOLDER
Foreign medical devices, cosmetics, foods, and sanitizers manufacturers or
distributors/exporters worldwide that do not have a physical office/location in
Brazil must appoint a Brazilian Registration Holder – BRH. This can be achieved in
many ways, but the most practical (and useful one) is appointing an independent
ANVISA representative.
With an experience of 15 years in the Brazilian market, we are a registration
holder, ready to make your product legalized in Brazil. As a Brazilian office, we
can act as your independent BRH and you will be in charge of how the product will be
marketed in the country, without being tied up to a local company that may be
underperforming its sells and distributions. Our experienced consultants in Brazil
will also guide you through each step of Brazil's registration process. As your BRH,
we can:
Provide authorization to place Solufy Brazil Holder’s name, address, and phone/fax number
on your device submissions and registrations to ANVISA.
Act as a link between ANVISA and your company during the registration of your
products and provide access to the device’s documentation for ANVISA’s inspection,
if necessary.
Request B-GMP (Brazil’s Good Manufacturing Practice Certificate) quality system
inspections on your behalf and submit self-inspection reports to ANVISA
Assist in the renewal of your device’s registrations.
Coordinate with distributors to elaborate import authorization letters, necessary
for other distributors to import and market your product in Brazil.
Assist you in the event of a recall or incident report.