How to register Autoclave at ANVISA?

What are autoclaves?

Autoclaves are equipment with an ideal process for sterilization, they are used under pressure, with water in liquid and gaseous forms.

What is needed to register an autoclave with ANVISA?

To register an autoclave with ANVISA, it is important to present studies such as safety and efficacy tests. These tests are mandatory for all types of products regulated by ANVISA. In addition, information regarding each type of product is requested, such as: composition material, maximum temperature reached, instruction manual, accessories and others. In the case of imported products, generally the tests and reports from the country of origin are accepted by ANVISA, however, it may request new tests for further evidence.

To obtain the registration of the autoclave directly, it is essential that the company has the proper regularization. If your company is not yet regularized by ANVISA, see below the necessary steps for the regularization of your company, thus being able to continue the process of registering the autoclave.

How to regularize your company?

The regularization processes to be able to register an autoclave with ANVISA consist of two steps:

Operating License – Local Sanitary Surveillance (VISA), in this process it is up to the company to adapt its structure to receive an inspection. The municipal or state VISA inspector will verify your location following the guidelines of the Collegiate Board Resolution (RDC) according to the activity carried out by your company.

The next step is the Company Operating Permit – ANVISA, this process takes place in Brasilia. At this time, fees are collected, documents are compiled and others.

Steps completed, now you can register your autoclave.

Registering an autoclave with ANVISA may seem like a complex bureaucratic process that requires the assistance of competent advice and consultancy. Stone Okamont is the right consultancy for your business! Count on us to assist in all processes to register an autoclave with ANVISA.

Don't waste any more time! Fill out the form below, talk to one of our professionals and get all your questions answered about how to register an autoclave with ANVISA.