10/11/2020

How to know if a product needs registration with ANVISA in Brazil?

Our content today will make you understand how to know if a product needs registration with ANVISA. When this question arises, many people do not know how to find the answer, but we are here to help you understand and facilitate the entire journey. Check it all out here!

 

What should I know before I understand if a product needs registration with ANVISA?

Your product may not need registration specifically. Depending on the type (category) of the product, its classification and its degree of risk to health, it is possible to divide the regulatory issue into two different directions, as follows: the product can be:

1. Exempt from registration - Notified. In this case, the degree of risk to the health of the product is small, which is why ANVISA does not require the entire bureaucratic registration process. But that does not mean that the product will be “discarded” in the eyes of the National Health Surveillance Agency: any product exempt from registration needs to be notified to ANVISA.

2. Registered. In the latter case, the process is very detailed and often full of bureaucracy. So, to achieve success, a series of documents is needed, as well as more time.

 

How to know if a product is exempt from registration with ANVISA in Brazil?

It's simple: you can search for the category and classification of your product on ANVISA's own digital platform. As the creation of products is infinite, it is impossible to determine a specific rule for each one of them, but it is possible to “fit” some of them in equal classes. For this reason, ANVISA provides ways for you to find out if your product is exempt from registration or not: basically, just access the platform and search for the product you want to know.

Recently, in the exempt category, for example, personal hygiene products and children's cosmetics and perfumes (HPPC).

 

How to know if a product needs registration with ANVISA?

If your product is not exempt, it needs registration. In the case of a product that will still be placed on the market, that is, without registration, it is necessary, initially, to know the category of the same (food, cosmetic, medicine, sanitizing, etc.). After identifying the product category, it is time to check its classification.

 

How to know the product classification?

There are some categories of products that have more than one classification in the ANVISA parameters, because they have a higher health risk than others. After identifying the product category, it is necessary to observe the corresponding Collegiate Board Resolution (RDC). It is the DRC that shows the way to determine the classification of your product.

Thus, there can be more than one classification within a given category. It is for this reason that ANVISA still classifies products by their degree of risk, which increases or decreases the need for a more stringent list of instruction documents. Medicines and health products, for example, because they have a greater potential for health risk, have different classifications and, consequently, different rules to be followed in the registration process.

In the case of a product that is already being marketed, to find out if it has been submitted to registration with ANVISA, first of all, it is necessary to check if this information appears on the label, as well as the name of the person responsible for manufacturing. This information is mandatory for the product packaging.

The ANVISA digital platform allows you to find ways to know for sure whether your product needs registration or not. If you still can't do it, we're on hand to help!

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How to register a product with ANVISA with efficiency, agility and economy?

At Stone Okamont the bureaucracy is zero! Want to find out how to know if a product needs registration with ANVISA? We can give you all the answers you need! We are specialized in regulatory intelligence to satisfy the needs and dreams of our customers. That's right! Leave all worries to the care of those who really understand the subject!

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Editor: Maria Júlia Carminati

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