Hosting Service - ANVISA

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.