Regulatory Support
Expanding your medical device business into Brazil represents a promising opportunity—but navigating the country’s regulatory requirements can be complex. All medical devices must comply with the standards established by Anvisa (Agência Nacional de Vigilância Sanitária), the Brazilian Health Regulatory Agency responsible for regulating health-related products and services.
For companies unfamiliar with Brazilian legislation, the path to compliance can seem overwhelming. That’s where our regulatory services come in. Our specialized team works alongside your company to support the registration and notification of Anvisa regulated products, helping you navigate each stage with clarity, efficiency, and confidence.
How We Make Compliance Easy
We offer end-to-end regulatory support to help your product reach the Brazilian market. Our services are tailored to the specific classification of your device and the applicable regulatory pathway—whether it requires notification or registration.
Some of the key activities we handle include:
Preparing and reviewing documentation according to Anvisa’s requirements;
Reviewing INMETRO certificates, when applicable;
Compiling technical files and assembling dossiers in accordance with Anvisa’s expectations;
Submitting petitions for product registration, notification, modifications, or retifications;
Providing guidance in response to Anvisa’s requests, including technical clarifications or required adjustments;
Supporting the localization of user manuals and instructions for use in Brazilian Portuguese;
Assisting with updates related to manufacturing sites, product labeling, and model lists;
Reviewing marketing history, clinical evaluations, and risk management documentation;
Coordinating communications and follow-ups with Anvisa until final approval.
This comprehensive approach enables your company to stay focused on your operations while we manage the regulatory demands required for market access in Brazil.
Why do you need this service?
Save time and reduce costs: A detailed document review early in the process minimizes the likelihood of rejection or repeated submissions, helping to avoid costly delays.
Alignment with local expectations: Brazilian regulatory requirements are unique. Our experience helps prevent common errors and facilitates better communication with Anvisa.
Focus on what matters most: While we handle the regulatory process, your internal teams can remain focused on product development, commercialization, and strategic growth.
Partnering with a regulatory affairs specialist not only reduces risks and streamlines your market entry, but also ensures ongoing alignment with evolving legislation—helping you maintain business continuity and avoid potential compliance setbacks.
Whether your company is preparing for a new product registration with Anvisa, updating an existing submission, or responding to agency requests, we are ready to assist. Rely on Sobel’s expertise in regulatory affairs to minimize risks and streamline your go-to-market strategy.
Looking for Regulatory Assistance?
We understand the importance of timing, accuracy, and compliance in the Brazilian market. That’s why we continuously monitor regulatory updates, adapt strategies accordingly, and work closely with your team to ensure the documentation meets Anvisa’s current requirements.
Our support model is built on clear communication, technical accuracy, and full alignment with your business goals—providing you with a strategic partnership to guide your company through medical device registration with Anvisa.
If you are looking for a reliable partner to support and streamline your regulatory processes in Brazil, we are here to help.
Take the first step toward hassle-free compliance with Sobel!
