Overview
Brazil has implemented significant changes to the importation of medical devices. These changes, introduced through Collegiate Board Resolution RDC No. 810, amend the existing rules laid out in RDC No. 751, effective since September 15th, 2022.
Key Changes
One major change allows the importation of medical devices and accessories produced before the publication date of RDC No. 751. This simplifies the process for older devices.
Medical device imports, as defined in section 3 of the resolution, must now include a declaration issued by the notification or registration holder. This declaration confirms compliance with specific requirements, ensuring imported devices meet the necessary standards.
Devices imported under section 3 must remain within their validity period and adhere to current legislation, ensuring they are both compliant and suitable for use.
These changes take effect on June 18th, 2023. Importers have a 90-day transition period to adapt to the new documentation requirements.
Summary
In summary, these changes aim to simplify and clarify the medical device importation process in Brazil. By permitting the import of older devices, introducing declarations, and validating compliance, the country maintains high standards while facilitating imports. Importers and stakeholders have little time left to prepare for these changes that took effect June 18th, 2023, to ensure smooth operations as the 90-day transition expires tomorrow.