How to add health product use instructions in Anvisa’s portal?
June 17, 2021
Anvisa requires the attachment of health product information during their registration in the regulating body’s portal.
After the effectuation of the RDC no 431/2020, which enforces the upload of use instructions on Anvisa’s digital portal related to medical device notification or registration processes, companies legally constituted in Brazil and duly regularized within the scope of the Brazilian Health Regulatory System (SNVS) shall upload documents related to the addition and update of use instructions related to medical device notification or registration processes, through:
- Protocol of Equipment Use Instruction Availability application at Anvisa’s Portal;
- Protocol of Health Material Use Instruction Availability application at Anvisa’s Portal; or
- Protocol of In Vitro Diagnosis Product Use Instruction Availability application at Anvisa’s Portal.
Which products need these types of protocol?
See below which health products have an attachment with the protocols referred by Anvisa:
- PIECE OF EQUIPMENT – Use Instruction Availability at Anvisa’s Portal
- MATERIAL – Use Instruction Availability at Anvisa’s Portal
- IVD – Use Instruction Availability at Anvisa’s Portal
How the information is added in the process?
Initially, the companies must have a medical device regularized with Anvisa. As established in the RDC no 431/2020, the uploaded use instructions will be exclusively published in Anvisa’s digital portal once the respective application protocol is concluded, regardless of the document analysis performed by the Agency.
The documents are directly uploaded by the company responsible for the product’s regularization, which states that its content strictly observes the governing law and the information currently approved for the respective processes of notification or registration with Anvisa.
At its sole discretion, the product’s images and labels can be uploaded and directly executed by the company responsible for the product’s regularization, which states that its content strictly observes the governing law and the currently approved process of notification or registration with Anvisa.
This type of protocol is required for every process?
According to the RDC no 431, OF OCTOBER 13, 2020, for products regularized before the effective date of this Resolution, the use instructions shall be uploaded within 12 (twelve) months after this regulation’s effective date.
And for every product regularized after the effective date of this Resolution and for changes on existing regularizations, the use instructions shall be uploaded within 30 (thirty) days after the application’s favorable conclusion or after unreported change implementations that involve use instruction changes.
Single paragraph. In case of non-compliance of the governing law or inconsistency that justifies health measures, Anvisa shall be entitled to halt the commercialization, importation, and/or use of the product until the proper use instructions are uploaded according to the terms hereof and the provision of art. 15 of Law no 6,437/1977.
How Licempre can help you?
As a specialized company with a team ready to help others during the process of information attachment of products that require registration with Anvisa, Licempre will be there to guide you and take care of the entire process of product regularization, according to the regulating body’s requirements.
For more information, get in touch with our experts.