Brazil ANVISA Medical Device Labeling/IFU Requirements

B

bethlaiu

1.Can company x delete the description of the "country of origin" from IFU without any additional action to ANVISA, while we remain its description in labelling? If we need any additional action (new application, notification and documentation etc.), please tell me the complete action.
2. what kind of changes in IFU or labeling (changes in Indications for use, warnings, cautions, trade name etc.) make us need to take additional action to the approval (new application, notification and documentation etc.)?
3. How much does it cost to get the approval of class IV in Brazil
 
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