Are You Filing Your Reports to INVIMA on Time?

Getting the sanitary registration does not close the process: it opens it. From that point on, the holder has reporting obligations that stay in place while the product is on the market. These are the post-market surveillance reports, and filing them on time is part of keeping the registration in good standing.

If you are the holder of a sanitary registration, the manufacturer, or the party responsible for a regulated product, these reports involve you directly.

What these reports are for

Post-market surveillance lets INVIMA monitor a product’s safety once it is in real use, outside the controlled conditions of the registration. With that information, the authority can spot situations that cause adverse effects early and act before the problem grows. For the company, beyond being an obligation, it is a source of improvement: the reports show where to adjust a product or a process.

Surveillance systems by product

The type of report depends on the group the product belongs to. INVIMA runs specialized surveillance systems:

• Pharmacovigilance, for medications.
• Technovigilance, for medical devices and biomedical equipment.
• Reagent vigilance (reactivovigilancia), for in vitro diagnostic reagents.
• Food health surveillance, for food safety.

In cosmetics there is cosmetovigilance, a more recent front whose scope is worth confirming against the current regulation. Each system has its own framework, so it is worth verifying which one applies to your product before deciding how to report.

What gets reported, not only adverse events

It is common to think only adverse events get reported, but the obligation is broader. Depending on the product, you must also report thefts, product failures or defects, and the alerts or health measures involving a product registered in Colombia. Leaving out any of these fronts leaves the surveillance incomplete.

Each report has its own timing and format

Depending on the type of vigilance and the product group, there are set dates, frequencies, and platforms or formats for filing each report. The specific timelines depend on the rule that applies to your product, so the prudent thing is to confirm them rather than assume them. What matters is that each responsible party has a clear program: who reports, what gets reported, by when, and through which channel.

Filing late has consequences

The reports are not optional. Failing to file them, or filing them late or incomplete, can lead to penalties and to doubts about how the registration is managed. Having a reporting routine, with owners and reminders, is the way to avoid that risk.

At SPI Américas we support technovigilance reporting for medical devices, so your reports go out complete and on time. If you want to review where your company stands today, get in touch.