Regulatory Strategies
The Brazilian legislation establishes that only national companies can register medical devices in Brazil, and these companies must have local and federal sanitary licenses. Foreign companies that wish to sell their products in Brazil must establish a local Brazilian manufacturing unit or a local office. Another option is to appoint a partner company legally constituted in Brazil, such as Qualithings, that will be the holder of the authorization issued by Anvisa (the Brazilian Registration Holder, or BRH) and legally responsible for the products imported to and distributed in the Brazilian territory. In other words, foreign manufacturers must have a Brazilian agent who has a business license in Brazil and will communicate with Anvisa in Portuguese on your behalf. The BRH will be responsible for maintaining the registration during its lifetime.
Product Registration Options
If you choose an Authorized Representative or Hosting Services to be your BRH:
Authorized Representative
To simplify sales activities of medical devices in Brazil, an excellent solution is appointing an authorized representative. An authorized representative is usually an importer that has solid knowledge of its area of expertise and extensive market share. In most cases, they are large companies with a complete structure dedicated to international business. These companies will usually bear all the expenses from product registration to customs fees, with a counterpart: have exclusive rights over the product in Brazil.
The main advantage is having sound experience and rapidly enter the market, without the need to establish a subsidiary in Brazil and get all the licenses required by Anvisa.
Hosting Services
To simplify the registration process, an option is to hire hosting services. With hosting services, product registration will be issued on behalf of a third consulting party that owns and hosts the registration and provides an import authorization for any distributors designated by the manufacturer. In this case, the consulting party will only act as the BRH and will not perform any marketing, distribution, or sales activities. This option gives more flexibility and control of the manufacturer over the product than appointing an importer for that role. And there’s no need to choose an importer or distributor beforehand. It also reduces time and costs without binding to one agent.
The "QualiThings" Advantage:
We take the best out of both options and bring them to your company!
QualiThings is licensed to act as your BRH – and more!
Where most Brazilian Registration Holders focus only on the registration processes and others only on sales, QualiThings works with Regulatory Affairs, Quality Assurance and all aspects related to nationalization, distribution, and commercialization of medical devices.
We are a consulting company and work as a boutique office with modular services, which means that we leave our clients free to make their own decisions and pick-and-choose which services they want to hire. This way, our clients know exactly what they are paying for and, overall, it turns out cheaper for them.
The Brazilian legislation allows the BRH to give import permits authorizing the distributor(s) of your choice to import your devices, which means you will have full control over your registration and technical documents.
Once your product is registered in Brazil, you can choose if you want to work with your own distributors or if you want to use our network. If you decide to use your own distributors and they cannot import products into Brazil, you can choose to hire your own importation partner or you can hire QualiThings.
Choosing a...
Representative
... as your BRH:
Pros:
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Large companies with solid knowledge and extensive market share
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Minimal short-term investment required
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Customer service
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Sound market experience
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Cons:
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Exclusive rights (the manufacture can sell the products only to the authorized representative)
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The BRH “owns” the product registration​​​​​​​​​
Choosing...
Hosting Services
... as your BRH:
Pros:
-
More flexibility and control over the product and the registration
-
No binding to one agent – the manufacturer can choose the distributor(s)
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Sound Regulatory Affairs experience
​
Cons:
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More investment
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Lesser control of the market
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Distributors are usually small companies with little knowledge of the market
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The BRH is a third-party with no knowledge of the market
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Services provided are limited to regulatory affairs
Choosing...
QUALITHINGS
... as your BRH:
Pros:
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Sound experience in Regulatory Affairs, Quality Assurance, import, distribution, and related areas of the Brazilian market for medical devices
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Overall reduced costs
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Flexibility
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No binding to one agent
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Extensive network of specialized experts
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Modular services (you pay only for what you really need), no hidden costs
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Customer service
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Less bureaucracy - There's no need to establish a subsidiary or get all the licenses required to sell in Brazil
​
Cons:
We can't think of any!
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Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726