How to register a product with ANVISA?

How to register a product with ANVISA?

For those of you who don't understand how to regularize a product with the National Health Surveillance Agency, we at Stone Okamont have prepared this content to help your registration process.


Topics of this blog:

  • ANVISA regularization process;
  • Your product is subject to registration with ANVISA;
  • What is risk classification;
  • What is summary rejection;
  • How to optimize product registration at ANVISA.

Regularization process at ANVISA

Product Registration at ANVISA takes place before marketing. This regularization certifies that your product complies with current legislation and is able to be marketed in the category for which it was requested.

Stone Okamont operates in the elaboration of the entire technical process of registering products with ANVISA. We have prepared this blog to assist you in “How to register a product with ANVISA”.

Is my product subject to registration with ANVISA?

The first important point you need to know is whether or not your product is regulated. Anvisa regulates 12 groups of products, the main ones being: medicines, health products (materials and equipment), cosmetics and sanitizing products. If you are already sure that it is regulated, you can now start your registration project with ANVISA.

What is Risk Rating?

To understand product registration with ANVISA, it is first necessary to understand risk classification. Each product group is classified in a way and these classifications can be found described in legislation, such as in RDC 185 of 2001, which describes medical products. The documents to be presented at ANVISA are directly related to the classification of the product. For example, companies that are regularizing class I and II products do not need to present a Good Manufacturing Practices Certificate (CBPF), whereas those that are regularizing class III and IV products must, obligatorily, present this certification.

Also, for class III and IV products, proof of safety and efficacy is required, preferably through clinical studies, but in some cases, such as products with established technology, we can present a technical report based on the analysis of indexed publications.

summary rejection

During the analysis of the registration process submitted to ANVISA, requirements may arise, but rest assured that this is normal, however, care must be taken in compiling the documents to be submitted, since the absence of basic/mandatory documentation can lead to what We call it summary dismissal.

How to optimize product registration at ANVISA?

Even with all the bureaucracy involved, we can say that there is a way to optimize product registration with ANVISA.

Having a team trained and qualified in registering products with ANVISA contributes to increasing efficiency, productivity and safety at all stages.

For this reason investing in a specialized company is essential.

Get in touch with Stone Okamont and guarantee quality advice! We will be happy to register your product with ANVISA.

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