In order to reinforce the notification and monitoring system in health surveillance, after the online meeting which took place on 16th December 2021 with the State Surveillance Representatives, the Brazilian Regulatory Authority Agência Nacional de Vigilância Sanitária – ANVISA provided the online database Technovigilance Alert which allows a quick consultation of adverse events related to Medical Devices.
An informative database on risks associated to the use of Medical Devices
ANVISA’s aim is to facilitate access to information regarding Medical Devices, in order to rapidly update healthcare workers, patients, and medical sector stakeholders on risks associated to the use of Medical Devices.
Information accessible in the database concerns notices published by ANVISA on the risks for public health, specific information about the products, problem description, actions to be taken with different device types, and suggestions by the Manufacturer or the owner of the product registration.
The most commonly performed actions in the field include products withdrawal, equipment correction, software updating, and sending letters to customers with specific instructions on issues detected and how to respond.
It is up to the Manufacturer or to the owner of the product registration to manage and carry out actions in the field with the aim of lowering the risk of adverse events linked to the use of medical tools already placed on the Country’s market.
The database allows to rapidly search for notified field actions as of mid-2019, as well as Notices of device-vigilance issued by ANVISA from the year 2000.
In addition to the possibility of being able to plan activities on the ground to reduce the risk associated to the use of the products; all this information, thus, allow a better execution of the monitoring process and an increased efficiency of the surveillance system of Medical Devices.
Do you want to market Medical Devices in Brazil?
If you are a foreign Manufacturer and you want to sell Medical Devices in Brazil, you have to appoint a Brazilian Registration Holder (BRH), namely an Authorised Local Representative in charge of among other things providing the required documents for the registration process at ANVISA.
Thema can provide you the right support since it carries out the Brazilian Registration Holder (BRH) service.
For further information on the service contact our Customer Service!
ANVISA, Plataforma de alertas de Dispositivos Médicos e tecnovigilância está disponível, 31 december 2021