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ANVISA Registration Holder Service for Device Companies With No Office in Brazil

Brazil Registration Holder for over 200 device companiesForeign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian (Medical Device) Registration Holder (BRH). This company acts as a liaison between your company and Brazil's National Health Surveillance Agency (ANVISA) and is responsible for your medical device registration in Brazil.

Important things to consider when selecting a Registration Holder

Many medical device companies elect to have a distributor coordinate their medical device registration with ANVISA. Distributors welcome this opportunity because they know that the name of the Brazil Registration Holder (their company) must be identified on the medical device registration certificates issued by ANVISA and they will "own" that approval for 5 years or more.  

Most medical device companies, in a rush to enter the Brazilian market, don’t realize this until it's too late. This could present serious issues for you as a manufacturer if you have a need to change distributors.

Appointing an independent Brazil registration holder

Here are some additional reasons to consider appointing an independent regulatory consulting company as your Brazil Registration Holder (BRH):

  • During registration, you will need to provide confidential design information on your medical device to your BRH. Most manufacturers prefer to provide this information to an independent regulatory consulting firm rather than a distributor.
  • The BRH will “own” both the registration and the GMP certification. Only the BRH can grant permission for others to import using the approval in their name. Once a BRH is assigned to the device, it cannot be transferred for commercial reasons (example: you wish to switch distributors).
  • Distributors are focused on sales and marketing, not regulatory issues. Will they keep you updated on important ANVISA regulatory changes in Brazil that affect your devices?

Choose Emergo as your regulatory representative in Brazil

With offices in the capital city of Brasilia, Emergo specializes in regulatory affairs and can act as your independent Brazil registration holder. Here’s why you should work with us:

  • Emergo acts as the official in-country regulatory representative for hundreds of medical device and IVD companies worldwide
  • As your BRH,  we will fully cooperate with you so that you control the approval of your device and who can import your products. 
  • Our experienced consultants can assist you with each step of Brazil’s registration process.

Please contact us for more information on Brazil Registration Holder (BRH) representation.

 

Ask us for detailed information about Brazil registration holder services.

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Listen to our 9 minute audio podcast interview on in-country representation in Brazil:

Interested in learning more about in-country representative requirements in Brazil? Emergo's Ann Marie Boullie, Vice President of Business Development, and Tatiana Sell, International Projects Manager, discuss the role of the Brazil Registration Holder (BRH) in this podcast interview.


Frequently Asked Questions

 

How are we actually able to control our registration if we select Emergo as our BRH?
Brazilian Regulation RDC 81/2008 allows registration holders to give authorization to other companies to import products. Through this regulation, Emergo can send a notarized letter authorizing your distributor(s) to import your devices. Therefore, you can change and add distributors at will, since Emergo will issue authorization letters to your customers as often as you need. Your commercial relationship with your distributor will be direct – Emergo does not need to be involved in the shipment release or payment cycle and remains an independent regulatory representative.

 

Can I transfer my registration to another company?
ANVISA generally does not allow transfer of a registration. According to Brazilian Resolution RDC 22/2010, registrations can only be transferred under the following scenarios: merger, spinoff, incorporation or succession of the BRH. Therefore, ANVISA would not allow a transfer if your distributor was not performing and you wanted to transfer your registration to another distributor/registration holder.