Digital thermometer is an instrument used to measure body temperature. It is a small device with a metal tip or nozzle to measure the temperature and a display to show the results.
The digital thermometer is classified by Anvisa (National Health Surveillance Agency) as a risk class II- Medium risk, so it is not necessary to obtain the Certificate of Good Manufacturing Practices to register a digital thermometer in Brazil. This certificate is mandatory for companies that work with products classified as risk III- High risk and risk IV- Maximum risk.
Anvisa is the Brazilian agency responsible for regulating products: correlates, medicines, cosmetics and others. Any product of these segments must be regularized before being sold in Brazil.
Knowing the risk classification is the first step to register a digital thermometer in Brazil. Here is some information on how this regulatory process for registering a digital thermometer in Brazil works.
In order to register a digital thermometer in Brazil, it is necessary to present tests that prove the safety and efficacy of the device, in order to guarantee a final, safe and quality product that will perfectly perform the function for which it was produced. In addition, specific information about the product will also be requested, such as: Composition material, instruction manual, components and others.
But, before regularizing the product, it is necessary to regularize the company! Below are two options for regularizing your company in Brazil.
Seeking to offer a quality service focused on the zero-bureaucracy method, we have the Holder Service. With this option, your company will have its products hosted by Stone Okamont through BRB (Brazilian Registration Holder). Choosing this option, after regularizing the products, they will be free to be sold freely in Brazil.
Establishment of a physical company: The first step to regularize the company is to establish a physical location following the rules imposed by VISA and Anvisa to then start the regularization of the company.
Operating License: Process requested from VISA (Local Health Surveillance)-(municipal or state). This regularization consists of adapting the physical location to the guidelines of the RDC (Resolution of the Collegiate Board) related to the activity performed by the company. Verification of conformities and non-conformities will be carried out by a Visa inspection agent.
Operation Permits (AFE): In this phase of regularization, documents are compiled, fees are collected, among other actions. The process must be filed in Brasília, it will be analyzed by Anvisa.
Register digital thermometer in Brazil is a complex regulatory process that requires the assistance of a competent adviser. Stone Okamont is the right advisor for your business! Count on us to assist in all processes to register digital thermometer in Brazil.
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