Anvisa to Discontinue Sicert Medical Device Certificate Issuance System
The Brazilian Health Regulatory Agency (Anvisa) has announced that the Medical Device Certificate Issuance System (Sicert) will be permanently discontinued on 3 July 2026 at 6:00 p.m., as part of the Agency's ongoing digital transformation programme. The move completes the transition to the new certificate generation tool integrated into the Solicita System.
According to Anvisa, the new solution became available in November 2025 and is now integrated into both the Solicita System and the Agency's Consultation Portal, expanding the self-service functionalities available for generating certificates for registered and notified medical devices.
Transition to the Solicita System
According to Anvisa, the new certificate generation tool was introduced as part of the Agency's digital transformation strategy.
During a six-month transition period, Sicert remained operational to allow users to validate certificates issued up to December 2025. Following the system's permanent closure, all certificate generation activities will be carried out exclusively through the Solicita System.
Reasons for the Discontinuation of Sicert
Anvisa explains that the decision to retire Sicert was driven by several operational and technological considerations.
According to the Agency, these include:
Security risks associated with maintaining the legacy system;
Operational difficulties arising from the need to use a web browser that is being discontinued by its supplier;
The need to optimise the Agency's information technology infrastructure resources.
Guidance for Certificate Generation
Anvisa recommends that users consult the Solicita System User Manual for instructions on generating medical device certificates.
According to the publication, guidance on the process is available in Section 6 – "Creating a Draft of a Certificate"(page 31) of the current version of the manual.
Relevance for Medical Device and IVD Manufacturers
The announcement is particularly relevant for medical device and IVD manufacturers placing products on the Brazilian market.
Topics of particular interest include:
Medical device certificate generation;
Use of the Solicita System;
Discontinuation of the Sicert platform;
Regulatory documentation management;
Digitalisation of Anvisa's regulatory services.
The publication informs economic operators that, following the permanent closure of Sicert, the Solicita System will become the sole platform for generating medical device certificates.
