Final Approval from ANVISA If ANVISA reviewers accept your registration application, the regulator

Final Approval from ANVISA
If ANVISA reviewers accept your registration application, the regulator then publishes the official registration number of your device in its Diário Oficial da União (commonly referred to as the DOU); your ANVISA registration is valid for five years. Timeframes for ANVISA approvals depend significantly on the classification of your device: lower-risk cadastre applications typically take three to four months to process, while Class III and IV device applications can take from six to 12 months to review. Please note, however, that device applications cannot be submitted until a B-GMP certificate is issued. These two steps cannot be completed concurrently and must be completed one after the other.