Apr 30, 2019

Brazilian medical device regulators are currently working to streamline and modernize market access via initiatives such as a new notification pathway for lower-risk devices, ongoing participation in the Medical Device Single Audit Program (MDSAP) and implementation of Unique Device Identification (UDI) requirements. Below, we’ve compiled several important Brazilian market and regulatory news items from the past several months.

Ahead of the upcoming 2019 Hospitalar healthcare and medical technology conference in São Paulo, manufacturers should be aware of the following ANVISA efforts and announcements affecting medical device registration and compliance in Brazil.

ANVISA’s new Notification pathway for low-risk devices and IVDs

In May, ANVISA plans to launch its Notification pathway allowing Class I devices and IVDs streamlined access to the Brazilian market; these products currently must undergo cadastro registration prior to commercialization.

Improved review time frames, increase in device modification submissions

ANVISA reported improved performance in terms of meeting 90-day review targets for medical device and IVD market applications between July and September 2018, but also received higher volumes of modification submissions from registrants due to changes to importation and inspection policies in Brazil.

UDI comes to Brazil

Brazil has joined other medical device markets in introducing UDI requirements for some higher-risk devices such as implants and coronary stents. New UDI regulations from ANVISA are anticipated to go into effect in 2020.

New regulations for custom-made devices

Brazilian regulators have also established a new regulatory process targeting custom-made and patient-specific medical devices, replacing a previous system whereby manufacturers had to submit special requests to ANVISA in order to import such products into the country.

Learn more about Brazilian medical device regulations at Emergo by UL: