In January 2018, the validity of medical device registrations increased from 5 years to 10 years, after the publication of RDC 211/2018. Thus, the registrations granted or revalidated in 2013, which would need to be revalidated in 2018, as the period of 05 years would expire, had their validity extended to 10 years. Thus, only in 2023 would it be necessary to renew them.
This means that ANVISA has not received a single request for revalidation of medical device registration for five years. That's about to change.
The deadline for requesting registration revalidation is between 6 months and 12 months in advance of the expiration date. Thus, records expiring in 2023 may have already applied for revalidation.
However, ATTENTION!
Since 2013, a lot has changed, and it is important to REVIEW the records for submitting the revalidation request. Some rules have changed and it is important to note them before submitting requests to renew your registrations. We suggest that this analysis be done in advance!
Some issues worth reviewing and updating when submitting your revalidation request:
- Clinical Evaluation
- Risk management
- Performance and stability tests
- Grouping for sanitary registration
MSC MED will conduct a task force to review records that will expire in 2023. If you have records in your portfolio in this situation, please do not hesitate to contact us.
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