How to register prosthesis at Anvisa?

How to register prosthesis at Anvisa?

Are you looking for how to register a prosthesis at Anvisa? In this content we will explain this process  step-by-step, so you need to read the content until the end,don't miss any details and register your prosthesis with Anvisa correctly.

The prosthesis is a part or device that aims to meet the total or partial needs of the limbs or organs of the body.

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What is needed to register a prosthesis at Anvisa?

To register prosthesis with Anvisa, you must  regularize your company, for that, there are some steps that shall be followed.

The first step is to obtain your Operating License, this is done with Visa – Local Sanitary Surveillance in your municipality. In this phase, the company adapts to Visa's parameters to receive an inspection.

If there is any nonconformity, the company will have a stipulated period to correct and receive a new inspection. At the end of a successful inspection, your Operating License will be issued, and then it will be possible to proceed to the next step.

The second step is to acquire your Company Operating Authorization (AFE), this process is filed and takes place entirely in Brasília, as it is analyzed directly by Anvisa – National Health Surveillance Agency.

In this step, documents, petitions, collection of fees and others are compiled.

Security requirements.

The prostheses must meet the safety and efficacy requirements established in the Resolution of Collegiate Board of Directors nº 56, of April 6, 2001 or its updates, as well as the applicable standards and technical norms.

Compliance with the requirements related to the safety and effectiveness of the prosthesis must be verified by the health surveillance from inspection in production and registration to inspection in the trade.

Do I need a Good Manufacturing Practices Certificate to register a prosthesis at Anvisa?

The establishments that manufacture prostheses classified in classes III and IV, according to the classification provided in the Resolution of the Collegiate Board of Directors nº 185, of 2001 or its updates, must have a Certificate of Good Manufacturing Practices issued by Anvisa.

In case of doubt about the classification, the classification of the medical product will be assigned by ANVISA.

All ready! You can now register prosthesis at Anvisa

Regularizing a company and product with regulatory agencies is not an easy task! It requires a lot of skill and knowledge;  so Stone Okamont has excellent professionals, trained in several areas to suit your needs in an individual and personalized way.


Contact us! Fill out the form below, talk to one of our consultants and ask all your questions about how to register a prosthesis at Anvisa.

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