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Guidance of the Notification process for class I products

Anvisa published on Tuesday (2/4) a document with guidelines, in portuguese, for the regulated sector about the new standard of notification process of the medical devices and IVD class of risk I, regulated by the RDC 270/2019.

The document contains:

  • Clarification of the standard;
  • Information about the electronic petition process for products class I;
  • In addition to a scheme of frequently asked questions on the subject.

 With the new resolution, as of  May 2 , medical devices and IVD of class I,  should be submitted to a notification process, instead of a process of registration.

Note*: Products class of risk II remain subject to registration, as is currently the case.

Product Notification

The publication of the notification number will be in 30 days after payment of the ANVISA fee, only by the Anvisa website.

As of the validity of the new standard, the processes for regularization of medical devices of risk class I that are awaiting the first manifestation of Anvisa will be treated as a notification system.

Tecnhical demand process in analisys, will only be included in this scheme if they are accepted through the granting of the notification number.

Anvisa further clarifies that the notification process does not require prior technical analysis for the regularization of the product, but does not dispense with granting the notification number.

Note**: Only with the grant of this number can the product be industrialized, exposed for sale or delivered to consumption.

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Source: ANVISA

Published: 04/08/2019

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