The timelines for the review and approval of medical devices in Brazil by the National Health Surveillance Agency (ANVISA) can vary depending on several factors, including the device's classification, the completeness of the submission, and ANVISA's current workload. However, ANVISA aims to process registration applications for medical devices within certain target timelines, which are outlined in their regulatory framework. It's important to note that these timelines are targets and actual processing times may vary.
ANVISA has established the following target timelines for the review and approval of medical device registration applications:
1. Class I Devices: ANVISA aims to review and approve Class I medical devices within 60 days from the date of submission of a complete application.
2. Class II Devices: For Class II medical devices, ANVISA targets a review and approval timeline of 90 days from the date of submission of a complete application.
3. Class III and IV Devices: Class III and IV medical devices, which are higher risk devices, typically undergo a more comprehensive review process. ANVISA aims to complete the review and approval of these devices within 180 days from the date of submission of a complete application.
