Medical Device Vigilance in Colombia

Obtaining the sanitary registration of a medical device does not close the regulatory process, it opens it. From that point the product stays under surveillance while it is marketed, and that surveillance has its own name: technovigilance.

What is technovigilance?

The National Technovigilance Program is the main tool for post-market surveillance of the medical devices marketed in Colombia. In simple terms, it is the system through which INVIMA monitors the safety of these products once they are on the market, to catch problems early that only become visible with real-world use.

The fuel of the whole system is information: the adverse events and incidents that get reported allow INVIMA to take preventive and corrective measures when a risk appears.

Responsibilities of manufacturers and importers

Under current regulation, those who manufacture or import medical devices have three core obligations toward the program:

1. Prepare a Technovigilance Manual with the corresponding procedures.
2. Appoint a person responsible for the program within the organization.
3. Report to INVIMA the adverse events and incidents associated with the use of the product in Colombia.

These responsibilities are not optional, nor do they end once the registration is obtained: they follow the product throughout its commercial life.

How and when to report to INVIMA

Adverse event reporting has two schedules, depending on the type of event:

• Immediate report: applies to adverse events or incidents and health alerts. It must be made within the 72 hours following the occurrence or knowledge of the event.
• Periodic report: filed each quarter, on the established dates. It must be submitted even when no events occurred during the reporting period.

That second point is often overlooked. Silence does not excuse the report: the absence of events is reported too.

Surveillance does not end with the registration

It is worth insisting on the time horizon. A medical device’s sanitary registration is valid for 10 years for all risk classes, and throughout that period the product remains under surveillance. Technovigilance is part of the surveillance function that INVIMA carries out permanently over products that affect health, alongside pharmacovigilance for drugs and reactive-vigilance for diagnostic reagents.

Setting up the program, keeping the procedures current and meeting the reports on time is what sustains the registration over the years. At SPI Américas we support manufacturers and importers in that task. If you manufacture or import medical devices in Colombia, write to us at [email protected].