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Distributor's Role in Recalls & Adverse Event Reporting

Distributors play a critical role in the recall and adverse event reporting system:

In recalls (recolhimentos):

  • Must maintain distribution records sufficient to trace all batches of a recalled device to their recipients;
  • Upon receiving a recall notification from the registration holder or ANVISA, must immediately stop distribution and remove the recalled product from their inventory;
  • Must contact all customers to whom the recalled device was distributed and arrange for return or quarantine; and
  • Must report the outcomes of recall actions (quantities quarantined, returned, destroyed) back to the registration holder.

In adverse event reporting:

  • Distributors who become aware of an adverse event involving a medical device they distribute must report it via NOTIVISA within the applicable timeframe;
  • Must cooperate with the registration holder's investigation; and
  • Must provide distribution records to ANVISA or the registration holder on request.
Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

Distributors must report adverse events via NOTIVISA within the applicable timeframe — typically within 30 days for serious adverse events or as specified in RDC 752/2022. The recall implementation timeline should also be clarified: distributors must typically implement recalls within 5 to 10 business days of notification, depending on the severity classification assigned by ANVISA.