Due to issues related to confidentiality in the processing of personal data, the National Health Surveillance Agency (Anvisa) received a notification through its Ombudsman requesting the removal of all files from health product processes inserted in its Portal at Internet.
In this sense, Anvisa published the Public Consultation No. 823, suggesting a new Collegiate Board Resolution (RDC) that provides for inclusions and updates of notification or registration forms, product images, instructions for use and / or labeling in the processes for regulating medical devices.
In general, medical devices are instruments, equipment, software, materials and articles used in medicine, combined or not, for diagnostic and therapeutic purposes, such as orthoses and prostheses.
Instructions and documents will be available Anvisa’s website. The protocol will become mandatory for all medical devices regularized with the Agency.
According to the text, the rules will cover the following items:
- Equipment: Instructions for Use and Labeling of Products Class III or IV, as well as availability of Form and Images of Products Class I or II ;
- Material: Instructions for Use, Labeling of Product Class III or IV and availability of Form and Images of ProductsClass I or II;
- IVD: Provision of Instructions for Use and Labeling of Products Class I or II and III or IV.
The tool allows companies to upload labeling documents, instructions for use, images and registration or notification forms. All data reported by the regulated sector are public and can be consulted by all interested parties.
It is important to emphasize that the inclusion or updating of the document must be done by the company responsible for regularizing the product, in strict accordance with the applicable legislation and with the characteristics of the regularized product.
The proposal of the new RDC also demands attention as to the deadline for the protocol for inserting or updating product documents regularized after the effective date of the RDC under consultation, and the protocol must be made within 30 (thirty) days after the regularization of the medical device that implies insertion or alteration of the document. It will also be necessary to observe the provisions in Annex I of the RDC draft, transcribed above, which details the petitioning matters.
After the publication of the new standard, the insertion, updating or non-inclusion of a document may be subject to documentary or fiscal assessment, and this at any time by Anvisa.
Failure to comply with these measures will give rise to the application of penalties in the face of companies that insert information in disagreement with the current legislation and that does not keep consistency with the regularized product, a situation in which the Agency will be entitled to suspend the marketing, import and / or use of the product until the insertion or update of the document in the event of non-compliance with current legislation or inconsistency that justifies such sanitary measure.
Contributions to Public Consultation No. 823 are open from June 22 to July 21, 2020 and, after this period, Anvisa will be able to subsidize further technical discussions until the final decision of the Collegiate Board.
