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How to register hyaluronic acid with Anvisa?

Do you know how to register the hyaluronic acid with Anvisa? Hyaluronic acid is a pretty common substance, used in the aging fight.

On this blog, you will learn more about how hyaluronic acid is registered with Anvisa.


What is hyaluronic acid?

Hyaluronic acid is a substance that is naturally produced by our body, however, over time together with the aging process, the body reduces its production capacity.

Its goal is to hydrate, revitalize, and give more volume to the skin, and when the production is reduced, wrinkles and frown lines start to appear.

For the treatment, the acid may be used in the gel form, when performing face fillers, and for correction of frown lines. It is also found in the market in the form of cream and capsules.

Furthermore, it can also be used for the correction of scars caused by acnes, as well as dark circles.


What is Anvisa’s risk classification?

Qual a classificação de risco na Anvisa?

The substance is classified with Anvisa as a health product, and as it is a substance injectable to the body, it is considered risk IV, that is, maximum risk.

As per Anvisa, products of risk IV undergo a more peculiar registration process, with more severe information about the product, such as composition, and must undergo clinical tests.

For the process to be carried out, it is necessary to send all the information about the product and follow some specific requirements, following RDC #185/2001.


How to register hyaluronic acid with Anvisa?

Como registrar ácido hialurônico na Anvisa

To register the hyaluronic acid with Anvisa, the company or manufacturer must follow some protocols to obtain the Operating License (LF), the Company’s Operating Authorization (AFE), and the Certificate of Good Practices of Manufacturing (CBPF).

After all the licenses being active, the company must present a detailed report of the product with all the information about it and follow the process phases and agreements with Anvisa.

The hyaluronic acid, for having the risk classification IV, undergoes a more complex process to assure the total safety of the product for its users.

Please note that depending on the form that the product is commercialized, it may be framed in the class of cosmetics, changing its risk classification and regulation process. Thus, if it presents features of a cosmetic product, the process to be followed will be the one for a cosmetic class product.

You can learn more on our blog: How to register cosmetics in Brazil

The product can only be commercialized or used after the process approval with Anvisa, approved in every phase. The manufacturing companies that do not comply with the registration process may be punished, being responsible for crime, and liable for fines.


Why should I register the hyaluronic acid?

Por que devo registrar o ácido hialurônico?

It is important to remember that products that do not comply with the regulations and demands from Anvisa are considered irregular products, and may cause risks to the population health, just as they do not have their efficiency, safety, and quality guaranteed.

Therefore, every product that is commercialized needs to undergo Anvisa’s regulation process, and only after the approval, it will be released to the market for commercialization, importation, and use.

Register your product safely.

Licempre is a company with expertise in regulation matters, with capable and experienced professionals, so that the companies have all the assistance when registering either a product or the company.

The great difference when hiring a regulation matters company is to assure less bureaucracy and more savings in the processes with regulatory agencies.


If you want to learn more about registering your product, see the other contents on Licempre blog or speak directly with one of our specialists.