By: Cindy Lazo
What is technovigilance?
It is the regulatory function of post-market surveillance of medical devices that includes a series of activities aimed at the identification, registration, evaluation, management, follow-up, and timely dissemination of information related to adverse effects and safety problems presented by medical devices during their use, as well as the identification of risk factors that may lead to the occurrence of these events in order to determine their frequency, severity, and incidence and prevent their occurrence.

In which case is a technovigilance report made?

• Medical device malfunction
• Results are different from those described in the insert.
• Adverse reactions or unforeseen side effects
• Inaccuracy in labeling or instructions for use
• Design defect
  Your voluntary reports can be submitted to the National Drug Directorate in relation to the CNTV (National Center for Technovigilance).