Anvisa Introduces Electronic Registration for International Manufacturers of Risk Class I and II Medical Devices
The Brazilian Health Regulatory Agency, Anvisa, has announced that companies can now file registration requests for international manufacturers of risk class I and II medical devices directly through the Solicita system.
The measure applies to international manufacturers of risk class I and II medical devices, including in vitro diagnostic devices, and uses subject code 80326.
Purpose of the Registration
According to Anvisa, registration of an international manufacturer — whether a manufacturing unit or legal manufacturer — is a necessary step for generating the Unique International Manufacturer Code.
This code provides traceability of product origin and must be indicated in regularization processes for imported products.
What Changes
Requests for the creation, alteration and inactivation of international manufacturer registrations for risk class I and II medical devices are now carried out exclusively through the Solicita system.
Anvisa states that the measure aims to modernize the service and ensure the integrity and reliability of registration data.
Risk Class III and IV Devices
For manufacturers of class III and IV medical devices, the procedure remains unchanged.
In these cases, the registration continues to occur simultaneously with the request for Certification of Good Manufacturing Practices, known as CBPF.
Availability of the Unique Code
The status of the request can be consulted in Status of Technical Documents.
If the request is granted, the new Unique Code can be consulted through Anvisa’s Consultation Portal or directly on the product petition screen.
If the code is not available after 10 business days from the filing date, and the company has not received an official letter explaining rejection, the user must request technical support through Anvisa’s official service channels.
Documentation Requirements
Anvisa highlights that requests with incomplete documentation or forms without signatures will not be accepted.
This reinforces the importance of ensuring that all registration forms and supporting documentation are complete before submission through Solicita.
Impact on Medical Device and IVD Manufacturers
For international medical device and IVD manufacturers supplying products to Brazil, the update is relevant because it changes how registration-related requests are submitted for risk class I and II devices.
Manufacturers and regulatory representatives should pay particular attention to:
use of the Solicita system;
subject code 80326;
creation, alteration and inactivation requests;
risk class I and II medical devices;
IVDs included in the electronic process;
Unique International Manufacturer Code generation;
traceability of product origin;
documentation completeness;
signature requirements;
monitoring request status and code availability.
For companies placing imported medical devices on the Brazilian market, the change supports greater digitalization of regulatory processes and reinforces the need for accurate manufacturer registration data.
