15/05/2020

How to register laser hair removal system in Brazil

How to register laser hair removal system in Brazil How to register laser hair removal system in Brazil

For the sale of this equipment, you need to know that it is necessary to regularize it with ANVISA. You must register a laser hair removal system in Brazil, making it legal for sale. In this process, information about the equipment such as application, technical data, handling will help in its classification.

Anvisa classifies the laser system for hair removal as a correlate and its class as risk III - High Risk, and it is mandatory to obtain a Certificate of Good Manufacturing Practices. This certificate is mandatory for companies with products classified from risk class III. These are rules established for each process that the product goes through. Learn more: Certificate of Good Manufacturing Practices.

Anvisa

Anvisa (National Health Surveillance Agency) is the Brazilian agency responsible for regulating products: sanitizing, cosmetics, correlates, food and others. Any product within these segments needs to be regularized before being sold in Brazil.

Knowing the product's risk classification is the first step in registering a laser hair removal system in Brazil. In this content we have the necessary regulatory steps for the registration of the laser system and the ways to save your time and minimize your costs.

What does it take to register a laser hair removal system in Brazil?

Initially, to register a laser hair removal system in Brazil, it is necessary to regularize the company in Brazil, going through all the procedures and costs of an appropriate physical location for importing or manufacturing it.

 Follow below two options of regularization of the company and its steps to register laser system for hair removal in Brazil.

Option 1 - Regularization of the company in Brazil

-Establish physical location following all the requirements of Anvisa and VISA.

- Enter a request for an Operating License: This process is carried out by VISA - (Local Health Surveillance) of the state or municipality where the company is established. The company must adapt its structure to receive the visit of the inspector who will assess the adequacy made based on the RDC - (Resolution of the Collegiate Board) related to the activity performed by the company. Learn more: Operating License.

- Request Operation Permits: Process verified by Anvisa. This takes place in Brasília and it is in the Federal Official Gazette (DOU) that its AFE (Operating Permits) is published. learn more: Operation Permits

Option 2 - Holder service

In order to offer a quality service and with our Zero Bureaucracy policy, Stone Okamont offers Holder service. This service is only possible because it is a ready company with a license and authorization to register a laser hair removal system in Brazil. BRH (Brazilian registration holder) registers its products, without the need to bear the costs of establishing a physical company, thus legalizing its product for sale and providing freedom of choice over how many representatives it wants to have. Learn more: Holder Service.

Product registration

Completing Option 1 or choosing Option 2, we filed for registration. In this stage, technical information about the product is requested, such as: safety and effectiveness tests, composition material, instruction manual, accessories, frequency and others to ensure that the product will perform its role without taking any risk to the final consumer. After ANVISA's analysis, there being no requirements, it sends the registration number for publication in an official diary, which must be placed on the equipment labeling. Now yes success and great sales!  learn more: Product registration

Did you have any questions about how to register laser hair removal system in Brazil?

Count on us to assist in the entire regulatory process!

Fill out the form below, talk to one of our professionals and take all your doubts about how to register laser system for hair removal in Brazil.

Editor: Gabriela Batman Carvalho

Request a budget

* Required Fields

Type your search