ANSWERED ON THIS PAGE:
- Are we required to appoint an in-country representative to sell in Brazil?
- What should we consider when choosing a Brazil Registration Holder (BRH)?
- What are the responsibilities of a Brazil Registration Holder?
What is a Brazil registration holder (BRH)?
Foreign medical device manufacturers without a physical location in Brazil must appoint a Brazil Registration Holder (BRH). The BRH acts as a liaison between your company and Brazil's National Health Surveillance Agency (ANVISA), is responsible for your medical device registration in Brazil, and is identified on the device registration. You must maintain your BRH for as long as you sell medical devices in Brazil, so it is important to choose your representative wisely.
Benefits of appointing an independent Brazil Registration Holder
Many medical device companies select a distributor as their registration holder in Brazil. But this can present serious issues if you ever need to change distributors. Most medical device companies do not realize this until it's too late. Appointing an independent ANVISA representative gives you the most flexibility and control over your registration in Brazil. Here's why:
- The BRH controls your registrations and your Brazil Good Manufacturing Practice (B-GMP) certification. Once a BRH is assigned to the device, it cannot easily be transferred without the cooperation of your original BRH. This is why you want a BRH who is not involved in selling your products.
- During registration, you will need to provide confidential design and testing results information to your BRH. Most manufacturers prefer to provide this information to an independent firm to protect their intellectual property.
- Distributors are focused on sales and marketing, not regulatory issues. Will they keep you updated on important ANVISA regulatory changes that affect your devices?
- A conflict of interest may occur in the event of a recall or incident report. If ANVISA questions an incident or non-compliance that occurred in the distribution system, will your distributor defend their company or yours?
Choose Emergo by UL as your BRH to register your medical device in Brazil
Emergo by UL is the official in-country regulatory representative for more than 2,000 medical device and IVD companies worldwide. With an office in Brazil, we can act as your independent BRH and remove any possibility that you will be stuck with an underperforming distributor for the duration of your registrations. Our experienced consultants in Brazil will also guide you through each step of Brazil's registration process. As your BRH, we will:
- Provide authorization to place the Emergo by UL name, address, and phone/fax number on your device submissions and registrations to ANVISA.
- Liaise between ANVISA and your company during registration, and provide access to device documentation for inspection by ANVISA if requested.
- Request B-GMP quality system inspections on your behalf and submit self-inspection reports to ANVISA.
- Assist in renewal of device registrations.
- Coordinate with distributors to produce import authorization letters.
- Assist you in the event of a recall or incident report.
- Act as the BRH for your INMETRO, ANATEL or MTE certificates
Appointing a registration holder is an important decision. Hiring Emergo is a small investment in maintaining flexibility and control over your registrations in Brazil.
Brazilian Registration Holder FAQs
How do we control our registration if Emergo is 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 your independent regulatory representative.
Can I transfer my registration to another company?
Brazilian Resolution RDC 102/2016, which went into effect December 25, 2016, allows greater flexibility for registration transfers. However, transfers will require the cooperation of the previous BRH: they must sign the transfer contract and ask ANVISA to cancel the registration under their name. ANVISA will issue a new registration number one the transfer is approved, but the registration will carry the original validity date.