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.