Technovigilance: what it is

Technovigilance is the post-market surveillance system that tracks adverse events and technical complaints related to health products, such as medical devices, materials and equipment. In Brazil, it is coordinated by Anvisa, with the involvement of state and municipal bodies. In HOF, products such as fillers and threads, which are regulated as devices, fall into this universe.

Why does it exist?

Even a registered product can show problems that only appear with large-scale use: a batch defect, an unforeseen reaction, a packaging failure. Organized reporting makes it possible to identify patterns, alert professionals and, when necessary, withdraw a product from the market. Without reports from services, this monitoring loses strength.

What is reported?

• Adverse event: any undesirable occurrence linked to the use of the product, such as an inflammatory reaction, nodule, vascular occlusion or necrosis.
• Technical complaint: suspected quality deviation, such as tampered packaging, a batch that looks different or unusual difficulty injecting.
• Near miss: a situation that could have caused harm, although it did not, a topic covered in near miss.

How does it relate to registration and provenance?

The product must have a valid health registration, and the professional must check its provenance and the invoice. Products without registration or bought through informal channels have no guarantee of traceability, and occurrences involving them are harder to investigate. The device's risk classification, described in class IV medical device, indicates the level of regulatory attention the product requires.

Technovigilance and clinic routine

The clinic should have a defined flow: who records the occurrence, within what time, how it is documented in the patient record and how the team guides the patient. When there is a security incident (in the data sense), the handling is different, governed by the LGPD (Brazil's personal data protection law). For questions about local obligations, the local health surveillance is the reference, and current rules must be checked directly on the official channels.

In Harmy

Harmy is an image projection app and is not an injection device. It does not record product lots and does not replace the patient record or reporting to the competent bodies.

Also called: health product surveillance.