The link between
your company and ANVISA.
Registration Holder Service for foreign manufacturers of medical devices.
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for a consulting pro.
The link between your company and ANVISA.
Registration Holder Service for foreign manufacturers of medical devices.
How it works?
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), responsible for the registration of medical devices in the country.
As this is a long-term relationship, choosing your BRH (Brazilian Registration Holder) is a very important decision, as while you are distributing your products in Brazil, you must keep your Brazilian registration holder.
How it works?
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), responsible for the registration of medical devices in the country.
As this is a long-term relationship, choosing your BRH (Brazilian Registration Holder) is a very important decision, as while you are distributing your products in Brazil, you must keep your Brazilian registration holder.
Critical aspects to consider when choosing your regulatory representative at ANVISA.
Many medical device companies select a distributor as the holder of registration 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.
Critical aspects to consider when choosing your regulatory representative at ANVISA.
Many medical device companies select a distributor as the holder of registration 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 your records and your GMP (Quality System Compliance) certification. Once a BRH is 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 and design results 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 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 his company or yours?
Focus
Distributors are focused on sales and marketing, not regulatory issues.
Flexibility
BRH controls your records and your GMP (Quality System Compliance) certification. Once a BRH is 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 and design results 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 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 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 owning a company in Brazil, acting as an independent BRH eliminates
any possibility of restricting your product to an underperforming distributor during your registrations.
As your BRH, QR Consulting will provide:
Why choose QR Consulting as your Registration Holder?
In addition to being licensed by ANVISA and owning a company in Brazil, acting as an independent BRH eliminates any possibility of restricting your product to an underperforming distributor during your registrations.
As your BRH, QR Consulting will provide:
Check some of our clients:
Check some of our clients:
