Regulatory Compliance in Brazil
Brazil Medical Device Registration
Is Brazil your first market to enter or are you able to lodge evidence from overseas approvals? We can support the preparation and submission of your technical documentation for from initiation. When you already have technical documentation for your device, we compare your existing documentation and supporting evidence to the Brazil requirements to identify the overlap and missing parts that need to be added. Together we determine the main differences between the country-specific requirements and EU/US medical device regulations to reduce your lead time to market.
Qserve has a Brazilian expert on the team who could communicate well with ANVISA and support Brazil's Medical Device Registration.
Benefits of Qserve engagement
Global support, local presence
- Qserve is a leading regulatory consulting firm offering medical devices and in vitro diagnostic regulatory and quality affairs services.
- We specialize in helping clients achieve and maintain market access around the world.
- Our team of experienced regulatory and quality experts have a deep understanding of the regulatory landscape and can help manufacturers navigate the complex requirements.
- Qserve uses a practical approach to support you every step of the way.
Market access Brazil
Do you want to learn more about Brazilian market access and its regulations?
We help you with a quick overview of:
- ANVISA RDC 751/2022
- The Brazilian medical device registration process
- Classification requirements
- Regulatory requirements
- Registration routes (general or customized to your device)
- Important guidance links
Market access Brazil