The autoclave equipment is classified by Anvisa (National Health Surveillance Agency) as a risk class II - Medium Risk correlate, and it is not necessary to obtain the Certificate of Good Manufacturing Practices. This certificate is mandatory for companies that work with products with risk classification III - High Risk and IV - Maximum Risk. Learn more: Certificate of Good Manufacturing Practices.
Anvisa is the Brazilian agency responsible for regulating products: cosmetics, sanitizing, medicines, correlates and others. All products in these segments need to be regularized before being sold.
There are some necessary regularization steps to sell autoclave in Brazil. In this content we will talk briefly about each regulatory step to sell autoclave in Brazil.
To sell an autoclave in Brazil, it needs to be registered. For this, it is important to present basic information such as: Safety and effectiveness 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. Generally, tests and reports from the country of origin are accepted by Anvisa, however it may request new tests for further proof. Learn more: Product registration.
To register products, it is essential that the company has the proper regularization. Below are two options for regularizing the company to sell autoclave in Brazil.
1: Establishment of Physical Location. In order to regularize your company and sell autoclave in Brazil, it is first necessary to establish a physical location, following the requirements of VISA and ANVISA.
2: Operating License - VISA (Local Health Surveillance). In this process, the company must adapt its structure to receive an inspection. The municipal or state VISA inspector will check your location following the guidelines of the RDC (Resolution of the Collegiate Board) according to the activity performed by the company.
3: Operation Permits - ANVISA (National Health Surveillance Agency). This process takes place in Brasília and every technical dossier must be filed for approval in the official gazette. For the protocol, it is necessary to collect fees that vary according to its size, in addition to compiling other documents.
Your AFE will be published in the official gazette and only after this publication will you be able to start the registration process to have the legalization to sell autoclave in Brazil
Stone Okamont has the objective of transforming the whole process into zero bureaucracy, facilitating the processes for you to sell autoclave in Brazil. Stone Okamont has all BRB - (Brazilian registration Holder), or Holder Services documentation to register your product without having the monthly cost of a physical company, being its annual installment. This function of hosting your product is provided by Holder Services. A faster process for your company!
Selling an autoclave in Brazil requires a complex regulatory bureaucratic process that requires competent advice. Stone Okamont is the right consultancy for your business! Count on us to assist in all processes to sell autoclave in Brazil.
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