> >>> Doing business in Medical Devices in Brazil

To market health and beauty products in Brazil, you must first register with the appropriate local agency: ANVISA, (National Health Surveillance in Brazil).

The ANVISA registration must be obtained before any commercial application for the following types of products:

This administratively complex process involves a high level of risk. Our services are intended to reduce this risk (commercial, legal, and technical) by taking these time-consuming steps for you.

Good To Know

Beyond navigating complex administrative issues, our work deals with a number of practices unique to Portuguese business culture:

  • Anvisa Registration must be requested through a Brazilian law firm that will own these records EXCLUSIVELY for five years;
  • The company must be in good standing and fully authorized by ANVISA.
  • This procedure is similar to that of the FDA.
  • The Anvisa registration process takes 6 to 12 months before your registration goes into effect;
  • he Anvisa registration is always held by the agency that filed the application.
Three Options Only

There are basically three ways to access the Brazilian market.

  • #1
    Having your own local branch (creation, merger/JV or acquisition): this approach involves the registration of your subsidiary and products in order to bring your products to Brazil. This option is usually slow and costly (medical staff hiring, etc.) and best justified for proven markets and businesses with high investment capacity and international infrastructure.
  • #2
      Using a local distributor:you will need to find and negotiate with a local distributor knowing that it usually carries several competing brands and often focus on one region or state. Statistically, this option most of the time, results in failure within 24 months and becomes very costly.
  • #3
    Joining forces with a trusted third party recognized by ANVISA, Group Trammit International (master distributor), get you up and competing faster and at much less cost with lower risk.

1 - Creating a local subsidiary
Cost
High
  • Property Investment(s)
  • Employing a doctor and / or pharmacist.
  • Business trips.
Implementation
12 to 18 months
  • Creating a business structure.
  • Registering your affiliate.
  • Registering your products.
Risk Level
Medium
  • Legal risks.
  • Salery and wage risks.
  • Commercial failure risks.

2 - Outsourcing to one of your local distributors
Moderate
  • Negotiating and ratifying a contract.
  • Often with a reference product and high commission.
  • Annual negociation.
10 to 12 months
  • Language and translation barriers in carrying out your requests.
  • Lack of responsiveness on the part of the distributor.
  • Lack of transeparency.
Very High
  • Legal risks(Brazilian contracts law).
  • Commercial risks.
  • (competing products).
  • Risks associated with the owenership of your registration. (exclusive rights).
  • Risks associated with exclusive distribution rights.

3 - Working with Trammit, a specialized hosting provider and Master Distributor.
Low
  • Presentation of a clear and accurate estimate.
  • Fixed amount per product (with discounts for multiple products).
  • No commission or percentage of sales.
9 to 12 months
  • Expedited process based on access and established relationship with ANVISA.
  • Your own dedicated billingual contact.
  • Documentation and case management is included with our services
  • Transeparency and full autonomy.
Low
  • Contats conform to French law.
  • No salery, administrative or overhead costs.
  • Operated by a trusted third praty who can provide local assistance whenever you need it.
  • No exclusivly agreements .
  • We can propose several regional distributors.