How to Register Software in Anvisa

Need to Register Software on Anvisa? Today the RAGB tells you everything you need to know about it. With this guide you avoid bureaucracy and rework. Check out:

Since 2017, the software sector has been growing in Brazil. The T.I sector was generally one of the first to react to the economic crisis that Brazil experienced in 2018, growing almost 7% compared to the previous year. Investing in technology in Brazil has a great chance of success.

The growth in the area of health Software has grown along with the market and so today we tell you everything you need to know to Register Software in Brazil. Check out:

How Anvisa understands the Software

In technical note number 04/2012 created by the National Health Surveillance Agency (Anvisa) defines which are the Software Regulated by Anvisa. As the municipality is directly linked to the Ministry of Health, it is responsible for the regulation of health software.

How to register Anvisa Software

The Registry of Software in Anvisa is similar to the one of Health Equipment.

The main difference between Software and correlates is classification. In addition to the risk grade rating, which ranges from I to IV, they should be previously classified into four types. Which are:

  • They do not need hardware to function.
  • Performed on isolated computers.
  • Marketed as a part or as an accessory to a hardware.
  • Those that do not have diagnostic, preventive or rehabilitation purposes.

The process for Registering Software in Anvisa can still be divided into two more options:

  • National software.
  • International software.

Get to know more about the differences in the Regularization of National and Imported Software:

 Regularization of National Software in Anvisa

The process for Registering National Software should be followed exactly as the record of correlates in general. The Agency does not register any products for individuals.

The producing company of the Software must be duly regularized before the autarchy before the regularization of the service itself and for this, some documents are required. Which are:

  • Operating License with the Municipal Sanitary Surveillance
  • Authorization of business operation with ANVISA (Brasilia).

Only after regularization of the company can we start to register your software at Anvisa.

Registration of Imported Software in Brazil

Registering Imported Software in Brazil may be easier if you choose Hosting Service. RAGB can host your Software, saving you time and money.

Our expertise in Regulatory Affairs allows us to offer faster and less bureaucratic the regularization of your Software.

Got any questions? Talk to one of our experts right now!

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