Brazil ANVISA Registration Holder for Medical Device Companies

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Foreign 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. Emergo Brazil, with offices in the capital city of Brasilia, can act as your independent regulatory representative.

Reasons to appoint an independent Brazil 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 the manufacturer must maintain them as a BRH for the 5 year term of certification. Unfortunately, most medical device companies, in their rush to enter the Brazilian market, do not realize this until it's too late.

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

During registration, you may 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.
In the event of recall and/or incident involving your medical device, especially one that occurs in the distribution system, will the distributor defend their company or yours?
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? Emergo Brazil is a regulatory consulting firm so keeping clients updated on regulatory changes is included in our service.
Issuance of registration certificates by ANVISA in the name of a distributor may limit your control over the device registration. The BRH will “own” not only the registration but also the GMP certification and only the BRH can grant permission for others to import using the approval in their name. Please note, once a BRH is assigned to the device, it cannot be transferred for commercial reasons (i.e. you wish to switch distributors) and can only be transferred, for example, if two companies merge or one is spun off the other. If you select Emergo as the BRH, Emergo will be identified on the registration and would fully cooperate with you so that you control the approval of your device and who can and cannot import your products.

Emergo Brazil is a professional, independent in-country representative that specializes in medical device regulatory affairs. Your success in Brazil is our goal.