Regulatory Open Forum

Hi everyone,

If there is a shipment ready for Brazil for a medical device Class II b, per MDR, please let me know if a company can ship with their current labeling (no country-specific information yet). 

I am not completely sure whether this labeling requirement applies only to new registrations or if it applies across the board to the devices manufactured prior to March 1, 2023.<o:p></o:p>

Please advise!

Thank you!

Azadeh

Hi Azadehsadat,

Medical devices can be shipped with their current labeling (no country-specific information) to Brazil but then specific country requirements must be added before commercialization (e.g. during incoming inspection stage at importer's facilities).

The RDC 751/2022 includes a couple of changes on labeling, but there is a transition period of 365 days which started on March 1, 2023.

BR Guillermo 

Hi everyone,

If there is a shipment ready for Brazil for a medical device Class II b, per MDR, please let me know if a company can ship with their current labeling (no country-specific information yet). 

I am not completely sure whether this labeling requirement applies only to new registrations or if it applies across the board to the devices manufactured prior to March 1, 2023.<o:p></o:p>

Please advise!

Thank you!

Azadeh