Products for in-vitro diagnostics, how to register?July 27, 2020
Health products to be registered with Anvisa need to follow a set of rules and guidelines. In-vitro diagnostics products are the solution for in vitro analysis used in laboratories to perform tests.
In this current blog post, you will learn more about what are the products for in-vitro diagnostics and how to register this type of product at Anvisa.
What are in vitro diagnostic products?
Firstly, we will understand what they are. Anvisa – (National Health Surveillance Agency), defines as:
By the formal definition, provided by the legislation (RDC n ° 36/2015, item XXVII of art. 3), products for in vitro diagnostic use are reagents, calibrators, standards, controls, sample collectors, materials and instruments, used individually or in combination, with manufacturer’s intended use, for in vitro analysis of samples derived from the human body, exclusively or primarily to provide information for diagnostic, monitoring, screening purposes or to determine compatibility with potential blood, tissue and organ recipients.
Also according to the regulatory agency, products for in vitro diagnostics are classified in the following risk classes:
Class I: products of low risk to the individual and public health
Class II: products of medium risk to the individual and public health
Class III: products of high risk to the individual and public health
Class IV: products of high risk to the individual and public health
The classification is based on some criteria such as technical and scientific or medical knowledge, as well as the importance of the information provided, epidemiological relevance, the relevance of the impact of the result to the indication and to public health and an indication of use specified by the manufacturer.
Therefore, the product registration must follow the classification rules following the demands for tests, information, documentation and evaluation.
How is the registration of products for in vitro diagnostics done?
Before registering the products for in vitro diagnostics, the company must be regularized. After that, the process for product registration with Anvisa can be initiated.
To register the product, the first step is to assess the degree of risk the product fits in and whether it will be necessary to apply for the Certificate of Good Manufacturing Practice.
After this step, the technical dossier and all the documentation of the product registration process are sent, to go through analysis and proof of product safety and effectiveness at Anvisa. Once approved, the product can be marketed by the manufacturer.
Registration by the family of products for in vitro diagnostics
The product registration process can be done in two ways:
- Regarding a single product: only one product or model in the same registration process.
- Product family: several products or models in the same process.
Lastly, following Anvisa’s rules, the interested party can choose how the registration can be made. It is important to remember that once approved as a single product registration it cannot be changed to a family registration, and the same with the family registration, once approved, it cannot be registered as a single product.
Why should I hire Licempre?
Now that you know how it’s done, you can safely register your company and product.
We as a company specialized in regulatory matters, guarantee more security in the process, agility and less bureaucracy, so you can be free from stress and safer with the regulatory affairs of your company.
Do you have any doubt? Talk to our experts and clarify them!