What is ANVISA?
Agência Nacional de Vigilância Sanitária (ANVISA) is an independent organization aiming
"To protect and promote health, ensuring the hygiene and safety of
products and services and taking part in developing access to it".
Similar to FDA and CE, ANVISA is the health control and enforcement agency of
goods and products entering the Brazilian market (domestic and international
origin). Goods and products include medical drugs, foods, cosmetics, cleaning
products, diagnostic devices, hospital equipment and much more. In addition
ANVISA is responsible for inspection and enforcement of services such as
emergency out-patient care, hospitalization, production etc.
What is the process of obtaining ANVISA?
In order to obtain ANVISA market clearance there is a structured process a
product/company needs to follow:
Find a local partner that has required certificates such as company working allowance (AFE), facility operation license (LF) and relevant Brazilian Good Practices certificates.
Get a device classification, from a local expert, which will also determine if audits are required. Classification consists of classes and rules (exceptions).
GMP audit and INMETRO certification for those devices answering specific criteria.
Prepare and translate required documents such as technical files, labeling, free sales certificate etc.
Submission of registration forms to ANVISA
Publication in the DOU and market clearance. Registrations are valid for 5 years
Why does my company need a partner in Brazil?
Foreign companies wishing to sell in Brazil are required to have a local establishment/partner who will act as their in-country representative withANVISA. The local partner will hold the ANVISA approval on behalf of thecompany and control all import/export/sales of the product. This approval isnon transferable from one partner to another, even if both parties agree to itand hold all required permits. Therefore, the decision on which Brazilian partnerto collaborate with can be crucial.
How can my company obtain a partner?
There are several ways for a company to set up a Brazilian entity:
Establish a Brazilian branch
Sign an agreement with a distributor/manufacturer (BASE Brazil can find a leading distributor for your company)
Host the marketing approval with a third party (BASE-Brazil can act as your company's partner).
What is the advantage of BASE Brazil?
BASE Brazil offices are located in both Israel (Herzelia) and Brazil (Sao-Paulo). When using BASE-Brazil hosting service the company keeps control (not ownership)over the sales network it establishes in Brazil and has the flexibility ofexpanding and changing the distributors it works with thus maximizing the salespotential.
In Addition, we will accompany you throughout the registration process, with our group of experts, and according to your company's requirements provideadditional services.
What additional services can my company receive from BASE Brazil?
Consulting and filing of ANVISA regulatory process
Establish sales network
Supporting the company in negotiations with distributors
Creating a network of key opinion leaders
Representation in local, regional and international exhibitions
Ongoing representation of your company in Brazil
Clinical studies in leading hospitals