Brazil Medical Device Registration

Qserve is your regulatory consultancy partner for medical device registration services in Brazil.

Achieving regulatory compliance ANVISA RDC 751/2022 Regulation

Brazil Medical Device Registration

Qserve supports the registration of medical devices and maintenance of registered products in the Agência Nacional de Vigilância Sanitária (ANVISA) database, the National Health Surveillance Agency. 

We understand the requirements for Brazil's Medical Device Registration protocol and are experienced in preparing the required documentation to legally register a medical device in Brazil. Market Access/Medical Device Registration in Brazil.jpg?preset=content

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. 


Do you need assistance with Brazil's medical device registration or go-to-market strategy?

Qserve is your trusted partner for market access in Brazil.

Contact us

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

How Qserve can help

  • Regulatory market access strategy
  • Registration support in Brazil
  • Technical documentation gap analysis
  • Classification assessment
  • ANVISA, INMETRO, ANATEL certification
  • Brazilian GMP support
  • Local independent license holding Brazil (Brazilian Registration Holder)
  • Translations of labels and IFUs based on requirements
  • Build MDSAP compliant QMS
  • Risk management
  • Clinical evaluation
  • Post-market surveillance
  • Vigilance reporting ANVISA

Contact us

News and events

Latest blogs, upcoming events or on-demand webinars