In recent years, companies working with oral hygiene products have been looking for new formulas and products that may be attractive to consumers.
One of the products widely used today to attract consumers is powdered activated charcoal, toothpastes and even brushes, with a promise to whiten teeth and be antimicrobial.
Ifyou are interested in marketing toothpaste with active charcoal continue reading our blog to understand how the whole process works until you register toothpaste with active charcoal.
Do you know what it takes to register toothpaste with active charcoal?
To register toothpaste with active charcoal in ANVISA it is important to present basic information such as: Safety and efficacy tests. These tests are mandatory for all types of products regulated by ANVISA.
The regularization of products exempted from registration is carried out in a simplified way and varies between products manufactured in Brazil and imported ones.
In case of imported products generally the tests and reports of the country of origin are accepted by ANVISA, however this may request new tests for further proofs.
To register products directly it is essential that the company has the due regularization. If your company has not yet been regularized by Anvisa, see below the necessary steps of company regularization, to be able to register autoclave in Anvisa.
Company regularization
The regularization processes to be able to register toothpaste with active charcoal in Anvisa consist of two steps:
Operating License - VISA (Local Sanitary Surveillance). In this process it is up to the company to adapt its structure to receive an inspection. The inspector of the municipal or state VISA will check your location following the guidelines of the RDC (Resolution of the Collegiate Board) according to the activity carried out by the company. Learn more: Operating License.
Company Operation Authorization - ANVISA (National Health Surveillance Agency). This process takes place in Brasilia and must be filed in a physical and digital way. At this point, fees collection, document compilation, and others occur. Learn more: Enterprise Operating Authorization.
After these steps are completed it will be possible to register toothpaste with active charcoal in Anvisa.
Record Types
There are two types of records for toothpaste with active charcoal: Grade 1 Records are those that have basic properties, which do not need to be proven initially and do not require detailed information as to how they are used and their restrictions on use.
Whitening Toothpastes (Whitening Toothpastes) need Grade 2 registration, as provided for in Annex II of Resolution RDC 211/2005; because they are products that need proof of safety or efficacy, as well as information about care, mode and restrictions of use.
Talk to Stone Okamont
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