The lung ventilator has the function of providing respiratory support, that is, maintaining the lungs in their functioning artificially. Lung ventilators are extremely important in intensive care units for critically ill patients.
Do you know what it takes to sell lung ventilators in Brazil? In this content we will briefly explain all the steps necessary to sell lung ventilators in Brazil.
Before selling lung ventilator in Brazil, you need to know the ways to carry out this action.
In Brazil, these products must undergo regularization before being sold, as well as cosmetics, medicines, sanitizers and correlates products. The agencies responsible for this regularization are VISA (Local Health Surveillance) and ANVISA - (National Health Surveillance Agency).
To sell lung ventilator in Brazil, there are two options: Establish a regularized company in Brazil and regularize the products, or join the Holder services.
Below we will explain how each option works:
Establish company in Brazil
To establish a company in Brazil, it is necessary to find a physical location that meets the requirements related to the type of activity that it will develop, in addition to the authorization of the municipality's master plan, after which a regularization order follows:
- Operating License: This process consists of adapting the company to receive an inspection by VISA. The VISA agent will inspect the place following the guidelines of the RDC - (Collegiate Board Resolution) related to product classification. In the event of situations not complying with the RDC, VISA will request corrections as required. Do you want to know more? >
- Operation Permits (AFE): This process, unlike the first, is protocoled in Brasília and is analyzed directly by Anvisa. In this phase there are petitions, collection of fees and compilation of documents, these must be done physically and online.
Product regularization
Before selling lung ventilator in Brazil, it is necessary to classify them. Anvisa has a risk classification system from 1 to 4, with 1 being the lowest risk and 4 being the maximum risk.
Anvisa classifies pulmonary ventilator as a correlate risk class 3 - High risk. Companies with products with a risk rating from 3 must obtain the Good Manufacturing Practices certificate. Good Manufacturing Practices are rules and standard operating procedures established for each step that the product passes.
Finally, to sell lung ventilator in Brazil, it is necessary to register. In this final stage, information about the product is presented, such as: Composition material, instruction manual, durability and others. In addition, it is essential to present reports and tests that prove the effectiveness and efficiency of the product. Anvisa generally accepts tests and reports from the country of origin, but it may refuse and require further tests. Do you want to know more? > Product Registration.
Holder Services
Choosing Holder Service allows you to take your products to Brazil without the need to establish a physical company, thus making it a much faster process. Stone Okamont hosts its products, as it already has the license and authorization for such activity, requiring only the registration of the product which will also be done by us. In addition, with Holder you will be free to choose how many distributors you want to keep.
Talk to those who understand!
It is necessary to go through a lot of bureaucracy before being able to sell a lung ventilator in Brazil. Stone Okamont has trained and updated professionals in the current legislation. You can count on us to help you in the whole bureaucratic process so that you can sell lung ventilator in Brazil.
Fill out the form below, talk to one of our professionals and ask all your questions about how to sell lung ventilator in Brazil.
