HOW WE HELP

INMETRO & ANATEL
Certification
support

Technical compliance that clears the way for ANVISA registration.

For many medical devices, especially those involving electrical components or wireless technology, ANVISA registration isn’t the only regulatory step. You may also need certification from other Brazilian agencies — specifically INMETRO and ANATEL — to demonstrate product safety and technical compliance.

When are INMETRO and ANATEL Certifications required?

INMETRO certification is mandatory for several categories of medical devices — such as electromedical
equipment (e.g. those subject to IEC 60601), hypodermic syringes and needles, gloves, condoms, and more. This certification confirms your product complies with Brazil’s safety and performance standards.

ANATEL certification is required for medical devices that use wireless technologies like Bluetooth or Wi-Fi. If your product connects to other devices or networks, this certification will likely apply.

If your product falls into one of these categories, certification must be secured through a Brazilian-accredited certification body before you submit your product for ANVISA registration.

Guiding you through the entire process

Our team has extensive experience with both INMETRO and ANATEL pathways. We’ll help you understand what applies to your device and guide you through the process from start to finish:

  • Document analysis: We review your current documentation, including IEC 60601 reports, to check what’s valid for Brazilian standards.
  • Certification Body and Lab selection: We help you choose the right certification body and accredited testing lab for your product and timeline.
  • Coordination: We request quotes, organize paperwork, and stay in touch with local partners so you don’t have to.

You’ll have full visibility and support while we handle the local side.

Our team knows how to keep things on track—advising on next steps, flagging potential issues early, and making sure everything is properly documented for your ANVISA submission.

Start with
the right
information

Get our exclusive step-by-step INMETRO & ANATEL Certification Flowchart and
understand how technical approvals fit into your Brazil market strategy.

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    How we help

    Medical Device Registration in Brazil

    Seamlessly navigate Brazil’s regulatory landscape with our support in registering your medical devices, including SaMD and IVDs, efficiently.

    Your brazilian regulatory team

    Whether you call us your Brazilian Registration Holder or Authorized Representative, DOMO Salute manages every certification and regulatory requirement for ANVISA, INMETRO, and
    beyond.

    INMETRO & ANATEL Certification support

    Receive expert assistance in managing the certification processes for your electromedical equipment and related devices, facilitating a smooth market entry.

    BGMP Certification management

    We guide you through the process of preparing and submitting the necessary documentation for compliance with Brazilian Good Manufacturing Practices (BGMP) standards, ensuring quality and safety.