Hosting, Registry Maintenance &
Regulatory Compliance
Hosting │ BRH
The Brazilian Registration Holder (BRH, also known as Host or Hosting service provider) – in Portuguese “detentor do registro” – is the company that “owns” the registration and responds directly to ANVISA as the entity legally liable for the medical device in Brazil.
The BRH possesses the right to sell and distribute your devices in the Country and is responsible for ensuring the quality and safety of your products in the Brazilian territory.
​
The BRH’s responsibility doesn’t end when the registration is granted. The BRH is also responsible for continuously monitoring the product use, answering to complaints, issuing warning and field actions, keeping the document repository updated, acting as a link between the manufacturer, ANVISA and the users, emitting import and distribution authorizations, etc.
​
So, you need to truly trust your BRH and count on them for sustainable growth.
Document Repository
In 2020, ANVISA created an online repository for publicly storing and accessing digital documentation of medical devices. With Resolution RDC 751/2022, registration holders are required to add their medical device’s Instructions for Use (IFU) to the repository and ensure that this information is kept updated.
​
The BRHs of newly registered medical products or of previously registered products that undergo changes must ensure that the product’s IFUs are added to Anvisa’s online repository within 30 days of these being published in the Official Federal Gazette (DOU).
​
It is important to note that any public advertising or communication regarding medical devices must be consistent with the information submitted to ANVISA by the BRH.
Registry Maintenance &
Regulatory Compliance
Product Registration Certificates are valid for 10 years and the renewal application must be submitted in a timely manner.
Any post-approval changes made to the medical devices must be sent to Anvisa, with relevant documents according to the current requirements.
​
As part of our daily routine, QualiThings follow all official publications, keeping updated with the latest news and regulatory changes.
More Than Just a BRH
Where most Brazilian Registration Holders focus only on the registration processes and others only on sales, we work with Regulatory Affairs, Quality Assurance and all aspects related to nationalization, distribution, and commercialization of medical devices.
Boutique Services
We work as a boutique office with modular services - our clients are free to make their own decisions and pick-and-choose which services they want to hire.
Network of Partners
We can connect you with our network of partners, distributors, and clients, to expedite market growth.
Flexibility to Transfer or Change Distributors
Brazilian legislation allows the BRH to give import permits authorizing the distributor(s) of your choice to import your devices, which means you will have full control over your registration, your technical documents, and your products.
Keep your Company and Product Compliant
We can timely alert the foreign companies in case any prompt action is required to maintain the product registration valid and avoid penalties.
...and much more!
Get in touch
Send us a message, we will be glad to help you through the pathway into the Brazilian market.
+55 (51) 3937-8726