The link between your
company and ANVISA
Brazilian Registration Holder Service for foreign medical device manufacturers.
Fill out the form and wait contact a consultant.
The link between your company and ANVISA
Brazilian Registration Holder Service for foreign medical device manufacturers.
How does it work?
In order for foreign medical device manufacturers to be able to distribute their products without having the company licensed in Brazil, it is necessary to appoint a Brazilian Registration Holder. The registration holder acts as a link between your company and the National Health Surveillance Agency (ANVISA), which is responsible for registering medical devices in the country.
Because this is a long-term relationship, choosing your BRH (Brazilian Registration Holder) is a very important decision, because as long as you are distributing your products in Brazil, you must keep your Brazilian registration holder.
Main aspects to consider when choosing your regulatory representative at ANVISA
Many medical device companies select a distributor as the registration holder in Brazil, but this can pose serious problems if you need to change distributors. By appointing an independent representative at ANVISA, you will have more flexibility and control over the registration of your products in Brazil.
How does it work?
In order for foreign medical device manufacturers to be able to distribute their products without having the company licensed in Brazil, it is necessary to appoint a Brazilian Registration Holder. The registration holder acts as a link between your company and the National Health Surveillance Agency (ANVISA), which is responsible for registering medical devices in the country.
Because this is a long-term relationship, choosing your BRH (Brazilian Registration Holder) is a very important decision, because as long as you are distributing your products in Brazil, you must keep your Brazilian registration holder.
Main aspects to consider when choosing your regulatory representative at ANVISA
Many medical device companies select a distributor as the registration holder in Brazil, but this can pose serious problems if you need to change distributors. By appointing an independent representative at ANVISA, you will have more flexibility and control over the registration of your products in Brazil.
Flexibility
BRH controls its records and its GMP (Quality System Compliance) certification.
Once a BRH has been assigned to the device, it cannot be easily transferred
without the cooperation of its original BRH. That's why it's best to have a representative
who is not commercially involved with your company.
Reliability
During registration, you will need to provide confidential test result and design information to your BRH. Most manufacturers prefer to provide this information to an independent company to protect their intellectual property.
Interest
A conflict of interest can occur in the case of a recall or incident report. If ANVISA questions
an incident or non-compliance that occurred in the distribution system, will your distributor defend his company or yours?
Focus
Distributors are focused on sales and
marketing, not regulatory issues.
Flexibility
BRH controls its records and its GMP (Quality System Compliance) certification. Once a BRH has been assigned to the device, it cannot be easily transferred without the cooperation of its original BRH. That's why it's best to have a representative who is not commercially involved with your company.
Reliability
During registration, you will need to provide confidential test result and design information to your BRH. Most manufacturers prefer to provide this information to an independent company to protect their intellectual property.
Interest
A conflict of interest can occur in the case of a recall or incident report. If ANVISA questions an incident or non-compliance that occurred in the distribution system, will your distributor defend his company or yours?
Focus
Distributors are focused on sales and
marketing,
not regulatory issues.
Why choose QR Consulting as your Registration Holder?
In addition to being licensed by ANVISA and having a company in Brazil, acting as an independent BRH eliminates any possibility of restricting your product to an underperforming distributor during registration.
Meet some of our partners and customers:
A structure dedicated to the development of your business.
A structure dedicated to the development of your business.
Fill out the form and wait contact a consultant.
