The nebulizer inhaler is classified by Anvisa (National Health Surveillance Agency) as a correlated risk class II - Medium risk, so it is not necessary to obtain the Good Manufacturing Practices Certificate.
Anvisa is the agency responsible for regulating products related to the health, sanitation and other areas, all products in these segments must be regularized before their sale.
Do you know what else is needed to sell nebulizer inhaler in Brazil? In this content we will talk about all the processes necessary to sell nebulizer inhaler in Brazil.
To sell nebulizer inhaler in Brazil, it needs to be registered. Product registration, it is important to have enough information to meet the standards established by Anvisa. All products must have safety and efficacy tests. Usually tests and reports from the country of origin are accepted, however it is not a rule and new tests may be requested. In addition, information directly linked to the product type is required. In order to sell nebulizer inhaler in Brazil, for example, information such as: Instruction manual, accessories that accompany the equipment, composition material for each item, effectiveness of nebulization and delivery of medication to the lung, safety of electrical equipment and others are needed.
But before registering the product so that it is possible to sell nebulizer inhaler in Brazil, the company also needs to be regularized.
Initially it is necessary that the company has a physical location in the country in order to be able to sell nebulizer inhaler in Brazil. From the physical location established, it is necessary to go through the following processes:
Operating license. with VISA - (Local Health Surveillance) is the first stage of regularization. It is up to the company to adapt its physical structure in accordance with RDC- (Resolution of the Collegiate Board) to receive the inspection of a VISA agent.
After that, its process goes to the federal level, being protocoled in Brasília and analyzed by Anvisa. The entire process must be prepared in a physical way and also be inserted digitally. Petitions, collection of fees and compilation of documents are some of the actions that take place in this process, that is the Operating Permits (AFE).
After these steps are completed, your company will be ready to register the product and sell nebulizer inhaler in Brazil.
Another alternative offered by Stone Okamont is the Holder service. With this service, Stone Okamont hosts your products without the need for your company to establish a physical location and to acquire a license and authorization. Stone Okamont has the necessary requirements with Anvisa, requiring only the registration of your product. This way you will have the freedom to choose how many distributors you want to keep in order to sell nebulizer inhaler in Brazil. Learn more> Holder Service
Selling a nebulizer inhaler in Brazil seems complicated due to the existing bureaucracies in the country. But we can help you, guiding and advising you in all processes to fulfill the requirements established here. Count on us to beat the bureaucracy and sell nebulizer inhaler in Brazil.
Fill out the form below, talk to one of our professionals and ask all your questions about how to sell nebulizer inhaler in Brazil.