Operating Authorisation and Licensing: preparing your company to operate in medical devices.

We manage applications for and maintenance of ANVISA Operating Authorisation (AFE) and municipal/state health licences, the legal conditions for manufacturing, importing, distributing or storing medical devices in Brazil.

Register See what we deliver
Operating Authorisation and Licensing: preparing your company to operate in medical devices.
What we deliver

We manage the entire company authorisation cycle, from assessing activities to approval and periodic updates.

  1. Assessment of activities requiring AFE (manufacturing, importing, distribution, storage and dispatch).

  2. Electronic applications for AFE and Special Authorisation (AE), where applicable.

  3. Obtaining the health operating licence from the local health authority.

  4. Company registration and compliance in ANVISA systems (petitions and Solicita).

  5. Updates, amendments and renewals of AFE and licences.

Deliverables

What you receive

AFE approved and published in Brazil's Federal Official Gazette.
Health operating licence issued by the local authority.
An organised, traceable application dossier.
A maintenance schedule and renewal alerts.
References

Reference standards

  • Law No. 6,360/1976 and Decree No. 8,077/2013 (company operations).
  • Current ANVISA AFE/AE resolution and local health authority requirements.
FAQ

Frequently asked questions

Let's talk

Is your company still awaiting ANVISA authorisation?

We speak the agency's language and manage AFE from initial assessment to approval.

Or leave your details and we will get back to you:

We have received your details.

Our team will contact you shortly. Thank you!