Disinfectants are important products for cleaning and disinfecting environments. Thinking about the high demand generated by this product, Stone Okamont prepared an explanatory material on how to register this product at ANVISA.
The registration process may be complicated, but the regularization of your company and product in the Brazilian National Health Surveillance Agency ensures the commercialization of the disinfectant.
Stone Okamont is a regulatory intelligence consultancy that offers the best ways to legalize disinfectant at ANVISA! Check out the content and ask your questions!
They are formulations that have microbicide substances in their composition and have lethal effect for non-sporulate microorganisms. They are: General purpose, Food Industries, Swimming Pools, Lactarians, Hospital for Fixed Surfaces and Hospital for Semi-Critical Articles.
In order to be able to legalize disinfectant at ANVISA, it is necessary that the manufacturer company or importer is also regularized with the competent agency.
The first step is to obtain the Operating License. It is based at the inspection carried out in the establishment by the Local Sanitary Surveillance (VISA).
The license approval means that the company has technical and operational conditions for the manufacture and storage of the disinfectant.
The Company Operating Authorization (AFE) is absolutely necessary to legalize disinfectant at ANVISA. Its approval comes from the analysis made by the Brazilian National Health Surveillance Agency.
If the company comply the requirements of ANVISA, the authorization of the company is published in the Official Gazette (DOU). This means that the process to legalize disinfectants at Anvisa has been successfully completed.
Allocated in risk category I, disinfectants will follow a notification process at ANVISA.
To do this, you must select some product and company documents in order to enter the notification with the Agency, some of which are:
1 - Reports, stability studies and reports;
2 - General company data;
3 - PH report.
In order to ensure that your registration isn’t rejected, you should be aware of the disallowed components. Substances exceeding the limit or have proven mutagenic, teratogenic or carcinogenic effects are prohibited by the Brazilian National Health Surveillance Agency.
Stone Okamont has nearly thirty years of experience in regulatory affairs at ANVISA. With highly qualified consultants, we present the best solutions for your disinfectant registration at ANVISA.
Stone Okamont created the Zero Bureaucracy method! We guarantee the approval of your sanitist's registration with more agility and reduction of expenses, optimizing processes and procedures.
Contact us, discover our efficient solutions and obtain your disinfectant registration at ANVISA! Click here!
Stone Okamont is also on Youtube. Click here to see the main issues related to ANVISA and MAPA.