Product Registration

What is it?

The Product Registration is a document issued by the brazilian National Health Surveillance Agency (ANVISA), legalizing it for commercialization. See which products require registration:

• food,
• health products (correlated),
• medicines,
• cosmetics and perfumes,
• sanitizing and cleaning products.

The product must be regularized before the commercialization. This regularization certifies that the company complies with the current legislation and is able to carry out the activities in accordance with its criteria.

Stone Okamont works in the elaboration of the entire technical process for registering products at ANVISA. We prepare the instructions for use, labeling, technical report and necessary forms, compiling all the information within the required formatting.

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Is product registration with ANVISA mandatory?

If your company manufactures products such as food, medicine, cosmetics, sanitizing products and/or related products, it must be duly registered at ANVISA to guarantee the quality, safety and efficacy of the product towards the population. 

Products can be notified or registered. For those who do not have knowledge, even a product exempt from registration may require consultancy regulatory assistance, since the complexity of interpreting resolutions requires authority and knowledge in the field.

How Product Registration works?

To understand the product registration is necessary to realize that the risk classification is divided into categories ranging from I to IV, with I being the lowest and IV being the highest level. Risk class I and II products can be notified, but III and IV necessarily require the registration and certification of Good Manufacturing Practices (CBPF).