Modification in the electronic submission system for Medical Devices

Anvisa has been working to centralize its routines in a single system – aka Solicita. In December, the action plan encompasses the transfer of procedures from the Health Products Technology Office (GGTPS) to Solicita.

All submissions for medical devices will be filed through Solicita, except for clinical trials and certificates, which remain under the current system.

The transfer will take place during December according to the calendar below:

Initial submissions of notification and registration will have a different form that must be filled in with all information. In this new form, the submission will be concluded only if all the required documents are attached.

All submissions will have electronic forms customized according to the submission scope and the inserted information will be used as the source for the Federal Register (DOU) publications of notifications and registrations.

Anvisa reported that some delays are to be expected during the transfer of procedures.

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