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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.