Brazil Class I Medical Devices Notification
On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015 and shall enter into force as of May 2, 2019.
To date, the regularization of Class I medical devices has taken place through the cadastro process. Under the new Resolution, the lowest risk products will be regularized through notification - a simplified system in which there will be no prior technical analysis of the petitions. The publication of the notification is expected within 30 days following the notification’s application and the payment of the ANVISA fee; that’s regardless of any documentary analysis by ANVISA. Only after the granting of the notification number can the product be industrialized or commercialized.
Here are some important topics featured in RDC 270/2019:
The documentation required for the initial request and alteration of Class I medical devices remains the same, only with the change from the cadastro form to the notification form.
The labels and instructions for use of notified products must comply with the requirements established in RDC 185/2001.
The notified products are exempt from revalidation.
ANVISA may cancel product notification in such cases when it is proven that the product or the manufacturing process poses a risk to the health of the consumer, the patient, the operator or third parties involved; it’s also the case when information is deemed insufficient or there is an error in the sanitary framework of the notified products.
The Technical Product Dossier remains mandatory for notified products.
The notifications, their alterations and other actions will be published exclusively in the ANVISA website, in the section of consultation to regularized products.
There will be no prior technical analysis of the notification requests; however, ANVISA reserves the right to make documentary evaluations of the notification processes at any time.
The new legislation applies to the processes awaiting the first manifestation upon its entry into force.
Class I devices already registered in ANVISA will have their cadastros automatically converted into notifications, maintaining the same registration number.
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