INVIMA Colombia Medical Device Postmarket Compliance
Medical device postmarket compliance in Colombia includes renewals, modifications, and vigilance requirements.
Medical device and IVD registration renewals in Colombia
Your INVIMA registration must be renewed to continue selling in Colombia. The renewal application should be submitted at least three (3) months before your device’s registration expires. Medical device registrations are valid for 10 years. For IVDs, renewal applications should be initiated six (6) months prior to registration expiration. Category I and II IVDs are valid for ten years; Category III IVD registrations are valid for five (5) years.
The renewal process will be similar to your initial registration process and will require an up-to-date product dossier. If your Class I or IIa device received automatic approval, you can obtain approval for your renewal application in a few working days following your submission. INVIMA performs official reviews for higher risk device renewals, which can take at least 90 days.
Medical device modification requirements in Colombia
Administrative modifications to your device can be submitted as change notifications, such as a change of importer or health license owner, as well as some product-specification changes, such as a change of composition, labeling, warnings, etc. Modifications that affect the security or effectiveness of the product, or changes to its design and chemical composition require a new registration. For IVDs, changes to basic composition, reformulations, or major changes to the initial approval characteristics require a new registration.
Documentation requirements for a change notification will depend on the type of modification being submitted. INVIMA approves change requests within a few working days as long as the documentation is complete. However, you may receive a request for information following your modification approval as INVIMA reviews your modification documentation in more detail. You have 90 days to fulfill a request for information.
Medical device Post-market Surveillance and Vigilance in Colombia
Medical device companies must establish a pharmacovigilance system to monitor their device’s performance and collect information about adverse events. Manufacturers and importers share vigilance obligations and must each submit a quarterly PMS report, called a Period Report, even in the absence of a reportable event. Serious adverse events must be reported to INVIMA within 72 hours of knowledge of the event; non-serious adverse events must be reported within eight (8) business days.
Frequently
Asked Questions
What is considered a medical device serious adverse event versus a non-serious event in Colombia?
A serious adverse event is an event concerning your device that caused or could have led to death or serious deterioration in the health of the user or patient. A non-serious adverse event is an event concerning your device that could not have led to death or serious deterioration in the health of the user.
An adverse event involving my device occurred in another country. Do I need to report it to INVIMA?
If the event occurred in the device’s country of origin, it must be reported to INVIMA.
What happens after an adverse event?
Manufacturers and importers must implement field safety corrective actions (FSCAs) once they become aware of an adverse event or incident and document the response in the Periodic Reports provided to INVIMA. If the event is serious enough that a recall is necessary, you must inform INVIMA that your device is being removed from the Colombian market, including specific batch numbers, the reason for the withdrawal, timelines for complete withdrawal, etc.
