In today's Blog we are going to talk about notification and registration, which are two different procedures required by the National Health Surveillance Agency (ANVISA) for the commercialization of products.
What will you see in this Blog?
Notification is a simplified procedure that applies to certain low-risk products, such as cosmetics, cleaning products and some medical devices. It is a form of communication to ANVISA about the commercialization of these products, with basic information about their composition, mode of use and safety. Notification is a legal requirement and must be made by the person responsible for the product before it is sold.
The National Health Surveillance Agency (ANVISA) has a list of products that can be notified before being sold, without the need of registration.
Personal hygiene products, cosmetics and perfumes, such as soaps, shampoos, moisturizing creams, among others;
Food supplements, such as vitamins, minerals, among other nutrients;
Low-risk health products, such as diagnostic products for in vitro use, like rapid pregnancy tests, for example.
It is important to emphasize that even for products that only require notification to ANVISA, it is still necessary to meet the health requirements, such as labeling, packaging, and product quality, to ensure the safety and effectiveness of the product to consumers.
Registration is a more complex procedure, which applies to products considered to be of high health risk, such as medicines, food for special purposes and medical equipment. Registration is a rigorous evaluation of the product by ANVISA, which requires a series of detailed information about its effectiveness, safety and quality.
There are several types of products that are required to register with the National Health Surveillance Agency (ANVISA). Some examples include:
Medicines for human use, including generics, similar and innovative.
Biological products, including vaccines, serums, immunoglobulins and blood products.
In general, ANVISA is responsible for regulating and inspecting the manufacture, import, export, commercialization and use of these products, in order to ensure its safety, efficacy and quality for the health of the population.
The National Health Surveillance Agency (ANVISA) is responsible for regulating and inspecting products that have an impact on the population’s health. To ensure consumer safety, ANVISA adopts different control processes according to the risk of the product to public health.
In the case of products that present a health risk considered low, ANVISA allows the manufacturer or importer to make a prior notification to the agency, informing the commercialization of the product. This notification serves to make ANVISA aware of the existence of these products on the market, but it is not necessary to analyze the product for its commercialization.
For products that present a health risk considered high, ANVISA requires the manufacturer or importer to register the product. In this case, it is necessary for ANVISA to carry out a technical analysis of the product and the documents presented to ensure that it is safe and effective before allowing it to be sold on the market.
The main difference between notification and ANVISA registration is the complexity and information requirements for each procedure. Notification is a simplified procedure applied to low-risk products, while registration is a more rigorous process that applies to products considered to be of high-risk.
Stone Okamont is a qualified advisory and consulting firm ready to serve your company! We use our expertise to improve processes and deliver exceptional results.
Let us help you achieve great success! Speed up and improve internal processes, structure your business and reach your goals without incurring unnecessary costs.
Request a quote here.