How Foreign Manufacturers Can Market Medical Devices in Brazil

For foreign medical device manufacturers to distribute their products in Brazil without having a licensed company in the country, it is necessary to appoint a Brazilian Registration Holder (BRH). This regulatory representative acts as the link between the company and the National Health Surveillance Agency (ANVISA), ensuring that all legal requirements are met.

The Importance of Choosing a Regulatory Registration

Choosing a BRH is a strategic decision that directly impacts the operation and distribution of products in the Brazilian market. Since this is a long-term relationship, the manufacturing company must ensure that the chosen representative offers security, reliability and regulatory flexibility.

Many manufacturers choose a distributor as the registration holder. However, this decision can bring challenges if there is a need to change distributors in the future. By appointing an independent representative, such as QR Group, manufacturers maintain full control over their regulatory registrations and ensure greater operational flexibility.

QR Group: Specialist in Medical Device Registration with ANVISA

QR Group has extensive experience in the regulation of medical devices in Brazil, offering specialized Brazilian Registration Holder (BRH) services to foreign manufacturers. Our commitment is to ensure an agile, transparent and secure regulatory process, allowing your company to operate in the Brazilian market in full compliance with ANVISA.

Advantages of Counting on QR Group as your BRH

• Independence and Control: Does not link registration to a specific distributor, ensuring flexibility.
• Regulatory Compliance: Experts in ANVISA standards to ensure compliance with all requirements.
• Quick Access to the Market: Optimized process to reduce bureaucratic deadlines.
• Continuous Management: Constant monitoring and updating of product registration.

If your company is looking for a strategic partner to facilitate the entry of medical devices into Brazil, QR Group is the ideal solution. Get in touch and find out how we can assist in the regulatory process with ANVISA.

Source: QR Group