The massager cream, is classified as cosmetic by ANVISA (National Health Surveillance Agency), that’s, it’s a product type that has the purpose of beautification. For the commercialization of this product to be approved, your company must be regularized with the competent body.
It’s necessary to understand that, in order to perform the petitioning of any product’s mandatory the regularization of the company responsible for producing and distributing the products.
For this, Stone Okamont’s at your disposal to answer your questions. Click on the link below and request your quote!
Request a budget
How can we help you?
To register massager cream with ANVISA, there’re several rules and steps that must be followed, this content’ll help you understand this process quickly and conveniently.
Contact Stone Okamont, we do all the work for you from start to finish. No rework and unnecessary expenses.
What’s the first step to registering massager cream?
In the first step it’s necessary to obtain the Operating License of your company from ANVISA.
The Sanitary License’s issued by visa (Sanitary Surveillance) local or state, during the initial petition, in order to regularize the company with ANVISA (National Health Surveillance Agency). After your company obtains the Operating License, you’ll need to file the AFE petition.
Company Operating Authorization
The Company Operation Authorization (AFE), is one of the most important regulatory steps for the success of your business, and for this reason, it’s necessary to count on specialized technical support.
As requirement of ANVISA, companies working in the health area automatically need a Company Operating Authorization (AFE) to follow the service in legality, that’s, within the rules provided for by law.
Risk Class for medical equipment
Cosmetics’re classified as Risk Grade 1 and 2. In grade 1, cosmetics fit products with basic properties, which don’t need to be proven initially and don’t require detailed information as to how they use.
Grade 2 cosmetics, on the other hand, are characterized by specific indications that require proof of safety and/or efficacy, information on care, mode and restrictions of use.
In the case of massage creams, ANVISA classifies them as grade 1.
Registration of massager cream at ANVISA
For each type of regularization, there’s a different process to be carried out with ANVISA. Notification or registration, are modalities of regularization of products. Each type of regularization modality presents a different process time.
In the case of massage creams, they’re classified as class I products because they have lower health risks. In this case, the product’ll only be notified to ANVISA.
How to register a product in ANVISA with efficiency, agility and economy?
At Stone Okamont, bureaucracy’s zero!
We have regulatory experts to advise you at all stages and ensure that the course of each process’s as quickly as possible at the lowest cost. Contact us! Fill out the form below, talk to one of our professionals and ask all your questions.
