RDC No. 270_2019 – NOTIFICATION OF RISK CLASS I MEDICAL DEVICES
On February 28th, a new resolution was publicated. The RDC No. 270/2019. The resolution provides for migration from the cadastre to the notification for medical devices of class I.
This Resolution applies to Equipment, Health Use Materials and In Vitro Diagnostic Products class I and becomes effective as of Maio 02nd.
Product notification: the act of communicating to ANVISA the intention to commercialize a medical product, designed to prove the right to manufacture and import medical products exempted from registration pursuant to §1 of art. 25 of Law No. 6,360 of 1976 and classified in risk class I, indicating the name, manufacturer, purpose and other elements that characterize it.
Alterations according the Resolution:
- For inventory depletion requests of finished products, it is allowed to import and simultaneously trade the versions involved until the expiration date or the useful life of the product.
- The labels and instructions for use of the medical product notified or cadastre must be according the requirements established in Annex III-B of the Resolution of the Collegiate Board of Directors – RDC No. 185 of 2001, as well as the requirements set in specific regulations.
- Equipment notified or registered must have an indelible label with registration number or notification number attached to ANVISA.
- The labeling of In Vitro Diagnostic Product must be in Portuguese or using appropriate symbology, and the secondary (external) labeling of in vitro diagnostic products should contain the following information: VI – the number of notification, cadastre or registration with the ANVISA; and; The primary labeling of the instruments must be indelible and contain the following information: IV – number of notification, cadastre or registration with ANVISA.
- The products of risk class I will have their cadastre automatically converted into notifications upon the entry into force of this Resolution of the Collegiate Board of Directors – RDC, considering the same cadastre number as the notification number.
- Summary rejection: The application for cadastre will not be subject to technical requirement in the absence of incompletely or completed documents, forms and declarations or missing information, giving the abstract rejection of the petition.
RDC Nº 270, february 2019 (in portuguese)
For more information and explanations about it, send us an e-mail: email@example.com
Passarini Regulatory Affairs