BR hubs

ANVISA Sanitary Authorization: Who Qualifies and What You Get

Learn if your clinic needs ANVISA authorization and what is required to maintain compliance for medical waste and sterilization.

This authorization is a requirement for clinical operations to ensure they meet health and safety standards.

Who it's for

This is intended for any clinic that handles medical waste or performs sterilization procedures.

What you get

You receive certification that confirms your clinical operations comply with federal health and safety regulations. This is often referred to locally as an Alvará sanitário.

What it costs you

While the direct cost is not specified here, you must invest time and resources into periodic inspections. You are also required to maintain strict adherence to all waste management protocols (Resíduos de saúde).

The catch to know

The most common pitfall is failing to maintain perfect documentation for your hazardous waste disposal, as this is a frequent point of audit.

How to apply

  1. Review the specific sanitary requirements for your type of clinic.
  2. Ensure your waste management and sterilization protocols are documented.
  3. Submit your application through the official government portal.
  4. Prepare for inspections to verify your compliance.

https://www.gov.br/anvisa/pt-br