Brazil’s medical device regulator ANVISA is nearing implementation of a new “notification” market pathway for low-risk devices.

According to Emergo by UL consultants in Brazil, the new ANVISA regulation will likely go into effect in May 2019. Under the notification pathway, Class I devices will not be required to undergo full cadastro registration and approval, providing faster access to the Brazilian market for qualifying products.

ANVISA notification requirements and review
Once ANVISA’s notification regulation is implemented, applicants’ documentation obligations will be similar to existing Class I cadastro requirements, which include technical dossiers and AVISA application forms. Applicants must also provide proof of relevant certifications such as INMETRO and ANATEL.

Once submitted, Class I device applications will not undergo technical reviews; instead, such devices will be notified to ANVISA once applications and fees have been received by the agency. The regulator intends to issue notification numbers to applicants within 30 days of receipt of submissions.

ANVISA plans to publish notifications only on its own website, not in the Official Diary. Manufacturers may begin marketing their devices in Brazil once they have received notification numbers and added them to their product labeling.

Maintaining ANVISA notifications
Manufacturers of notified Class I devices should be aware that ANVISA may cancel their notifications at any time due to lack of proper documentation, incorrect classification or complaints.

In addition:

Modifications to notified devices will be allowed once applications and fees have been submitted to ANVISA;
180-day limited stock depletion period requirements will no longer apply to Class I devices;
ANVISA will not allow transfers of notifications, so manufacturers will have to re-notify using new Brazilian Registration Holders (BRH);
Class I device notifications will not expire.
Emergo by UL will provide additional details as well as a link to the full regulation following its publication by ANVISA.