Brazil Medical Device Registration and Local Holder Support

COMPLIANCE IN BRAZIL

Foreign medical device manufacturers cannot hold an ANVISA marketing authorisation directly. You need a legally established Brazilian partner to act as the registration holder. MEDAGENT do Brasil combines local representation with practical support for documentation, submission and ongoing compliance.

What is a Brazilian Registration Holder?

The Brazilian Registration Holder is the local company legally responsible for the products registered, imported and distributed in Brazil. It represents the foreign manufacturer before ANVISA, holds the authorisation and manages essential regulatory activities throughout the registration lifecycle.

The route depends on the device type and risk classification. Lower-risk and higher-risk devices follow different regularisation pathways, and some products may also require additional evidence or certification.

Discuss your ANVISA registration

What MEDAGENT supports

  • Act as your Brazilian Registration Holder and official ANVISA-facing partner.
  • Assess the device, proposed grouping and applicable registration route.
  • Prepare, review and coordinate the required technical documentation.
  • Submit and maintain the ANVISA application or notification.
  • Support applicable Brazilian Good Manufacturing Practice and INMETRO certification activities.
  • Coordinate authority questions, updates, renewals and ongoing compliance actions.
How the Process works

4 Easy Steps to your successful launch in Brazil!

1. Enquire About Our Service

Let us know what services you’re interested in.
Enquire about specific services with us and get connected with one of our experts.

2. Getting Connected

We’ll follow up on your enquiry via your preferred contact method.
You’ll receive a tailored quote, service overview, and global launch support plan.

3. Send Us Required Documents

Complete the Checklist & Submit Documents.
We take care of the administrative processing and submit the necessary documents.

4. Finalization & Launch

Successful Approval & Ongoing Support.
After approval, we provide ongoing regulatory updates and support tailored to your requirements. We’re also available to assist with any additional needs as they arise.
Contact Us
FAQ - Brazilian Medical Device Registration

Frequently asked questions

Can a foreign manufacturer apply directly to ANVISA?

No. ANVISA states that foreign companies must work with a legally constituted Brazilian partner that is responsible for the imported and distributed products.

Does every device follow the same registration route?

No. The route depends on device type, classification and applicable rules. MEDAGENT can assess the product and identify the appropriate pathway.

Will we need INMETRO or Brazilian GMP evidence?

Some products and risk classes may require additional certification or manufacturing evidence. This should be assessed for the specific device before the filing plan is finalised.

Who owns the registration?

The Brazilian Registration Holder holds the local authorisation. Commercial, transfer and termination arrangements should therefore be clearly addressed in the written agreement and reviewed internally before appointment.

Start Your Registration Today

Stay Updated on Regulatory Changes

We publish monthly newsletters that summarise changes in medical device regulations on our LinkedIn Newsletter.

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MEDAGENT helps medical device manufacturers navigate regulatory requirements, quality management and compliant market entry across international markets.

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78570 Mühlheim
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