How to register sanitizing products at Anvisa?March 10, 2021
Sanitizing products are employed for sanitation, and they must be regulated at Anvisa according to the characteristics of each product and the requirements of Anvisa for them to be commercialized.
In this blog post, you´ll find out how to register sanitizing products at Anvisa.
What are sanitizing products?
Sanitizing products and home sanitizing products are products designed for sanitation, for either home environments or public environments. Sanitizing products can also be used as substances for water treatment.
Sanitizing products are substances such as liquids, sprays, wet wipes, among others, designed for sanitizing as well as disinfecting places and environments, in order to prevent the emergence of dirt, worms or bacteria.
In hospital environments, the presence of these products is very common for disinfecting and sanitizing hospital equipment, environments and materials, among others.
See the following description according to Anvisa – National Health Surveillance Agency:
Sanitizing Products, according to Act 6360/76’s section 3, are substances or preparations designed for sanitation, disinfection or home disinfestation, in collective and/or public environments, in common areas, and for water treatment, comprehending:
a) insecticides – designed to fight, prevent and control insects in residences, enclosures, public places and its surroundings;
b) rodenticides - designed to fight rats, mouses and other rodents, in residences, vessels, enclosures and public places; they contain active, isolated or associated substances that don’t pose risk to the lives and health of men and useful warm-blooded animals, when they’re applied compliant to the recommendations contained in its presentation;
c) disinfectants– designed to destroy microorganisms, in an indiscriminate or selective fashion, when they’re applied to inanimate objects or environments;
d) detergents – designed to dissolve grease and sanitize containers and canisters, and for application in residences
How are sanitizing products commercialized?
Sanitizing products can be found at stores and supermarkets, or in other commercial establishments. In order to maintain the safety of their commercialization, the company that sells the product must follow every regulation requirements by Anvisa, both regarding the company’s authorization to sell products, and to sell only registered products.
Manufacturing and importing companies also follow regulation rules in order to be able to commercialize or import sanitizing products.
Each and every sanitizing product must be registered at Anvisa before it’s commercialized.
How to register Sanitizing Products at Anvisa?
Sanitizing products must undergo the registration process at Anvisa, which begins with an electronic petition and goes through reports and technical tests to be approved.
They can fit in the Risk I group, which is liable to Notification, or in the Risk II group, which requires registration, according to RDC 184/2001.
Classification varies according to the characteristics of each product and must be evaluated by Anvisa.
It’s important to remark that above all the company needs the local Health Surveillance to request LF – Licença de Funcionamento (Operating License) and AFE – Autorização de Funcionamento de Empresa (Business Operation Authorization) at Anvisa.
For the company to be regular, it is necessary to make a registration, change the company size (optional) and then obtain the Business Operation Authorization (AFE). Only when the company finishes all these steps, it will be apt to register sanitizing products.
You can learn more in our blog reading the post: Sanitizing products registration at Anvisa: How to do it?
Why should one hire expert advice to register sanitizing products for health?
As we’ve previously seen, sanitizing products can be classified in risk I or II according to its characteristics. Risk classification defines the regulation complexity at Anvisa, and many companies fail in this process due to their lack of experience.
Advice on regulation matters allows companies to face that process in a faster, more economic fashion, and with much lest bureaucracy.
We at Licempre take care of regulation processes providing greater safety for companies, providing satisfying results on both bureaucratic and economic aspects.