Brazil ANVISA Registration Holder for Medical Device Companies

Foreign medical device manufacturers that do not have a physical location within Brazil must appoint a Brazilian (Medical Device) Registration Holder (BRH). This person or 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 Braizlian 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 name of a distributor may limit your control over the device registration. If you select Emergo as your BRH, Emergo Brazil will be identified on your registration certificate as the “Registration Holder” and will control the registration. However, becasue we are an indepependent company will no vested interest in selling your products, there is no incentive for us to prevent you from switching to another registration holder in the future. This is your choice.  

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

Please contact us for more information or a free proposal on Brazil Registration Holder (BRH) representation.