Preliminary Steps

 

A structured evaluation of key decision points each company has to face when entering Brazil.

This allows the company's decision makers to make a knowledge based decision regarding the company's strategy in Brazil. 

Market Reasearch

Besides the usual market research conducted prior to entering a new market, there are several issues that need to be addressed while preparing this analysis:

1.     General market data including trends, developments and size.
2.     Regulatory classification
3.     Taxes
4.     Local infrastructure i.e. manufacturing, distribution, representation etc.

Classification

The requirement for medical device registration and/or listing with ANVISA is determined by the classification of the device into four risk classes (I to IV) based on 18 classification rules. 

Classes I, II, III and IV represent low-, medium-, high- and very-high-risk devices, respectively.    Medical devices classified as Class I and Class II may or may not require registration depending on their use. In some cases they may require GMP audits similar to those of higher risk classes.

Class III and Class IV devices require listing and registration, and all the parameters and specifications of the device have to be given during the registration process.

To insure fluent registration process it is important to classify the device properly. 

Brazilian regulatory advisors can assist your company to determine the device
classification and evaluation of the related registration costs.

Taxes

There are 90 different taxes, duties and contributions that are currently charged in Brazil, Some are really specific and some almost unknown.

The main ones, however, are commonly known by anyone doing business in the country.

Taxes in Brazil can be divided into various categories, based on different governmental sphere:

  • Federal taxes, regulated and collected by the Federal government

  • State taxes, regulated and collected by each state’s government

  • Municipality taxes, regulated and collected per each municipality’s government

 

 

 

Sales Channel

Brazil consists of 26 states and a federal district divided to 5 regions. There are cultural and even language differences between the regions. When establishing a sales channel a company
needs to consider the complexity and relations between the regions and the states. Should we work with one distributor? Exclusivity? Should we cover the entire country or focus on one region? What about sub distributors? Knowing the answers to these questions supports the company's decision making process and establishing a strong and profitable sales network. 

 

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