Expanding your operations into the Brazilian market is an excellent opportunity for companies in the health, cosmetics, food, and pharmaceutical sectors. However, obtaining ANVISA (Brazilian Health Regulatory Agency) registration to market products in Brazil can be a complex and bureaucratic process. The good news is that there are different approaches to becoming an ANVISA registration holder, each with its own advantages and challenges.
In this article, we will explore the four main options and highlight the pros and cons of each model.
- Through Distributors
Medical device distributors already established in Brazil have the required health licenses and ANVISA Authorization to apply for registrations. This is a simple and more cost-effective approach to legalizing products in Brazil.
Advantages:
- Lower initial investment, as the distributor usually covers these costs and handles the regulatory bureaucracy.
- Faster market entry, as the distributor already holds the necessary health licenses.
Disadvantages:
- Limited control over operations and sales strategy.
- Complete dependence on the distributor to keep the registration updated.
- The distributor has greater leverage in commercial negotiations.
- Distributors often make it difficult to add new distributors or transfer the registration if needed.
- If the distributor loses the registration or faces regulatory issues, your transactions may be directly affected.
- In case of adverse events, there may be a conflict of interest between the distributor’s responsibility and the manufacturer’s. The distributor is likely to defend its own interests over the manufacturer’s.
- Starting a Company from Scratch
Opening your own company in Brazil to directly handle the ANVISA registration process offers full control but requires significant time and investment.
Advantages:
- Full control over registration, distribution, and market strategy.
- Flexibility to adapt operations as needed.
Disadvantages:
- High initial cost, including company setup, operational structure, taxes, and legal and accounting consulting fees.
- The company legalization process can be long and bureaucratic, delaying your market entry.
- Complexity in dealing with tax, labor, and bureaucratic issues.
- Adapting to the local culture may take time and could lead to operational frustrations.
- Independent Company for Registration Representation (Brazil Registration Holder Service – BRHS)
Using a BRHS allows foreign manufacturers smoother access to the country, with calculated risks and providing time to learn and adapt to this new market.
Advantages:
- Low entry barrier.
- Less bureaucracy for the foreign company.
- Fast market entry.
- Control over your own registration.
- Possibility to transfer registration ownership to third parties.
- No limits on choosing or changing distributors.
- Professionalism and independence of a consulting company to maintain registrations and post-market surveillance.
Disadvantages:
- Initial investment in regulatory consulting and annual maintenance for the registration.
- Acquiring a Shelf Company
Acquiring a Shelf Company — a company already registered in Brazil but not yet operational — can be an ideal solution for companies seeking a quick and efficient market entry. This option is becoming increasingly popular among companies looking to avoid the complications of starting a new company from scratch. It’s more recommended for companies with prior experience in the Brazilian market, either through a distributor or a BRHS. We recommend this step as a second phase when your business has matured in the market.
Advantages:
- Quick market entry, as a Shelf Company already has a CNPJ (Brazilian company registration number) and the possible authorizations.
- Significant reduction in bureaucracy and waiting time to start operations.
- Greater control over operations compared to using distributors or BRHS.
Disadvantages:
- Acquisition costs may be high, depending on the company’s structure.
- Risk of hidden liabilities if due diligence is not properly conducted.
- The company structure may need adjustments to meet your specific needs, such as changing the corporate name, address, or legal and technical representative.
Accelerate Your Entry into the Brazilian Market with Brisa Advisors
Now that you understand the main options for becoming an ANVISA registration holder, let’s focus on the most efficient, fast, and secure solutions: the BRHS service or acquiring a shelf company with Brisa Advisors.
At Brisa Advisors, we offer both BRHS services and Shelf Companies for sale, ready to operate, allowing your company to enter the Brazilian market quickly with the security of an already registered structure in full compliance with legal requirements. Here’s why our solution might be ideal for you:
- Immediate Market Entry
A) For companies unfamiliar with the Brazilian market, we recommend registering through our BRHS, Brazil Import Healthcare Solutions (BIHS). The registration application starts immediately, ensuring safety and reliability for your products.
B) Using the Shelf Company acquisition model, you can request registrations immediately after completing the acquisition process. This is crucial for companies seeking agility and speed in launching their products and is highly recommended for those with prior market experience via distributors or BRHS.
- Guaranteed Compliance with ANVISA
We understand that registration with ANVISA is one of the biggest hurdles for foreign companies. Whether using our BRHS service or acquiring one of our Shelf Companies, it will be possible to immediately start the registration process with ANVISA.
- Reduced Bureaucracy
By choosing Brisa Advisors’ services, you eliminate much of the bureaucracy associated with creating a new company. This allows foreign medical device manufacturers to focus on the strategic and commercial aspects of their business.
- Flexibility and Control
Unlike options with distributors or starting a company from scratch, by using Brisa Advisors’ services, foreign manufacturers maintain full control over their operation, allowing direct management of sales, marketing, and pricing strategy.
- Specialized Consulting
At Brisa Advisors, you will find comprehensive consulting to ensure that your company makes the right choice and maximizes the benefits of this strategy. Our specialists will support you throughout the process, from acquisition to the start of operations.
Comparative Table of Approaches to Becoming an ANVISA Registration Holder
| Discretion | Distributor | Start from Scratch | BRHS | Shelf Company |
| Time to Market Entry | Fast (via licensed distributor) | Slow (until company setup and licenses obtained) | Fast (BRHS has the necessary licenses) | Fast (company already set up) |
| Control over Operations | Limited (depends on the distributor) | Full control | Partial (BRHS holds regulatory control) | Full control |
| Initial Investment | Low | High (setup and structure costs) | Medium (BRHS costs) | High (acquisition costs) |
Conclusion
If you are looking for a faster and more efficient way to enter the Brazilian market and obtain ANVISA registration, contact Brisa Advisors. With years of experience and expertise in the market, we offer consulting services, BRHS, and ready-to-operate companies, simplifying bureaucracy and speeding up your entry into Brazil.
Get in touch with Brisa Advisors today to discover how we can help your company conquer the Brazilian market with security, speed, and efficiency!
Find out more about BPO in RA!
*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br
