Entering the Brazilian market with your IVD device? You’ll need need a trusted Legal Representative in Brazil. With Sobel as your partner, you simplify the process without risking compliance.
International manufacturers of in vitro diagnostic medical devices (IVDs) must appoint a local entity to act on their behalf before Anvisa. It’s a legal requirement that directly impacts your ability to register and maintain your IVD product in Brazil.
Sobel’s experienced team helps you meet these obligations with precision, allowing you to scale your market entry without disruption.
Appointing a Legal Representative for IVD registration in Brazil is not optional, it’s a regulatory necessity.
Without a recognized legal entity, your IVD medical device cannot be evaluated or approved by Anvisa.
Furthermore, Brazil’s regulatory system requires a local contact for ongoing obligations like vigilance, distributor updates, and agency communications.
Sobel acts as your local representative in Brazil, officially recognized by Anvisa to represent your in vitro diagnostic medical devices.
Our local support helps bridge the gap between your global operations and Anvisa’s requirements.
We offer expert representation services tailored for IVD medical devices (Class I to IV), ensuring regulatory compliance and operational efficiency in Brazil.
To support your IVD journey in Brazil, Sobel offers other strategic services that may be relevant to your project.
We also work with Medical Devices, and some of these services apply across both categories:
Register your IVD in Brazil with expert support from Sobel. We assist with Anvisa submission, documentation, classification and more.
Navigate regulatory affairs with us, covering planning, gap analysis, and ongoing support.
Get support to meet Anvisa requirements with expert risk management services in Brazil for medical devices.
Partner with Sobel as your Authorized Representative in Brazil. With Sobel, you minimize risk, ensure regulatory alignment, and position your IVD product for long-term success in Brazil.
We handle the regulatory complexity, so you can focus on innovation.
1. What is a Legal Representative in the context of Brazilian regulation? A Legal Representative is a local entity officially appointed to act on behalf of a foreign IVD manufacturer before Anvisa, Brazil’s health regulatory agency. This representative is responsible for managing the product’s regulatory process and ensuring compliance with national requirements.
2. Is a Legal Representative mandatory for IVD registration in Brazil? Yes. Appointing a Legal Representative in Brazil is a legal requirement. Without a designated local entity, your IVD product cannot be registered, evaluated, or approved by Anvisa.
3. Can the Legal Representative be different from the distributor? Absolutely. In fact, appointing an independent Legal Representative—separate from the distributor—gives the manufacturer greater control over regulatory matters and flexibility to work with multiple distributors.
4. What are the responsibilities of the Legal Representative? The Legal Representative handles all regulatory communications with Anvisa, including:
– Submitting and maintaining product registrations
– Holding the technical documentation locally (Technical File)
– Managing vigilance and adverse event reporting
– Supporting distributor qualification and updates
– Acting as the official point of contact for inspections or audits
5. How is the Legal Representative formally appointed? The appointment is made through a Power of Attorney (PoA), signed by the manufacturer and legalized for use in Brazil. This document gives the representative authority to act on the manufacturer’s behalf in all regulatory matters.
6. Does Sobel provide representation for all IVD risk classes? Yes. Sobel acts as Legal Representative for IVD medical devices classified as Class I to Class IV under Brazilian regulation. We are equipped to support complex, high-risk product registrations with full regulatory rigor.
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