INVIMA Postmarket: Renewals, Changes & Vigilance

INVIMA renewal and change control

Maintain the actual issued INVIMA registration or marketing permission and identify the applicable device or IVD renewal process. Ordinary medical-device registrations generally have ten-year validity; IVD validity and renewal windows follow the separate IVD rules. Read the authorization and current INVIMA FAQs rather than applying one filing window to every category.

Start renewal planning early enough to reconcile manufacturer/sites, models, quality evidence, labels, local parties and the change history. A valid initial file does not prove the current marketed device is unchanged. Separate document preparation, official procedure terms and applicant-response time in the calendar.

Assess changes before implementation

Do not categorize every composition or labeling change as a simple notification. The device framework and separate IVD rules determine whether a modification or new registration is needed. Retain the rationale, required submission and final authorization before implementing a change that requires approval.

Technovigilance for devices and the separate IVD framework

Medical-device safety monitoring is technovigilance, not a pharmaceutical pharmacovigilance program. Resolution 4816/2008 defines responsibilities, event reporting and periodic reporting for covered devices. Assess IVD reactive-vigilance requirements separately.

Serious device events/incidents have a 72-hour reporting framework under the applicable provision, while non-serious events are addressed through periodic consolidated reporting. International alerts affecting products commercialized in Colombia also require specific prompt assessment and reporting. Document the relevant trigger and time origin; do not wait for a quarterly report when an urgent rule applies.

A complaint-to-action record

Capture the device, lot/serial, local exposure, outcome, event chronology and earliest relevant knowledge. Assign reportability review, investigation and local submission owners. Preserve reports, acknowledgments, follow-up information and the reasons for any nonreporting decision. Ensure the local holder/importer receives global safety information promptly.

An adverse event does not automatically require the same field action in every case. Assess risk, affected units and the need for correction, recall or communication, then implement and verify the required action. Connect the findings to CAPA, risk management, labels, semantic records and the registration file. Pure Global can help organize the local responsibilities, reporting process and maintenance calendar.