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Hosting Service - ANVISA

The Brazilian Registration Hosting Service system is a program specifically designed for foreign enterprises wishing to market their products in Brazil in a practical, cost-effective, and safe fashion.


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Under this system, a Brazilian company is given the authority to obtain all the licenses, permissions, registrations and certificates required for foreign businesses to adequately operate and market their products. This process utilizes all of BRH’s regulatory documentation infrastructure, simplifying all the steps in the initial regulatory process for a foreign company.

Why choose RAGB?

We hold Operating Licenses and Business Operating Permits (AFE) that allow us to ensure that products, materials and equipment comply with ANVISA regulations. Furthermore, we rely on our multidisciplinary team, which has expertise on the regulatory structure of Brazilian government agencies. This makes the entire bureaucratic process faster and more easily understandable.

Why choose a Hosting Service?

An international company can only operate in the Brazilian market if it has a relationship of some kind with an entity in the country. This link may be established through:

  • Opening your company’s own office or plant in Brazil, or working through a distributor (RAGB can administer Turn Key projects or new company registration)
  • Utilizing a Brazilian Registration Hosting Service.

The Hosting Service is a strategic legalization option, since it facilitates compliance with business and product regulations.

What can be registered with the BRH of RAGB?

Healthcare products, supplies and equipment

Cosmetics, personal hygiene products and perfumes

In vitro diagnosis

Sanitizers

Household products

Food

Note: this service does not apply to pharmaceutical companies or products subject to MAPA regulation.


Why choose BRH Services instead of a distributor?

Although it is entirely possible to designate a distributor located in Brazil, there are valid reasons not to name a distributor or sales representative for the BRH function. To list a few:

  • Access to privileged information: Your company must grant access to information and documentation on your products (mandatory for registration purposes). This is problematic, as most companies prefer not to trust design information and (confidential) industrial secrets to the hands of their distributors.

 

  • Conflicts of Interest: A conflict of interest may occur, in the event of a Recall or an Incident Report between your company (the manufacturer) and the distributor. If ANVISA questions an incident, or an inadequacy in the distribution system, would your distributor defend themselves or your company?

 

  • Updating of regulatory changes: A distributor is focused on sales and marketing, not regulatory issues. They may fail to keep your company up to date on relevant regulatory changes in Brazil, or to provide opportune notifications when such changes affect your products.

 

  • Security: The issuance of registration certificates by ANVISA on behalf of a distributor might limit your control over registration of the device. The BRH would be the “Registration Holder” and grant other distributors or importers permission to market and import your products. Bear in mind, once a BRH service is hired, your product registration will be safe and may be transferred for commercial purposes (should your company desire to change distributors).

 

  • Complete Control: By utilizing RAGB as your BRH, we will fully cooperate with your company so that you have complete control over the approval process of your products, having the final say on who can or cannot import and market your products.

Some of the benefits of Hosting

Time Saving

The average time for a company to start legally marketing its products in Brazil is of one and a half year, depending on the product line. This time can be reduced to approximately three to six months when utilizing RAGB’s Brazilian Registration Hosting Service.

Free Choice of Distributors

The company has control over its registrations, and is free to choose as many importers or distributors are deemed necessary.

Cost Reduction

The company benefits from being exempt of costs related to the opening and maintenance of a corporate entity, such as the hiring of technical professionals, office rental, wages, telephone lines, among others.

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