Recalls and Corrective Actions Under INVIMA: What Manufacturers Must Prepare

1. Key takeaways

In Colombia, a recall is not a commercial action a company starts on its own initiative; it is a regulatory action executed under INVIMA directives as provided by Resolución 4816 de 2008. Running in parallel are field corrective actions — for situations where the product does not need to be returned but must be handled at the point of use; the company carries out the handling within the framework of the INVIMA directive and produces progress reports. In addition, periodic reports are submitted quarterly as a standing duty, and the accompanying serious adverse event reporting remains within 72 hours of awareness.

GRZAN’s conclusion is that what a company must prepare in advance is not the decision of whether to recall, but an execution chain that can move the moment a directive arrives — distribution records, lists of points of use, notification channels, retrieval paths and a progress report template. Missing any single link leaves the company passive during execution, and delays in execution propagate to the certificate itself through the ex-post verification rules of Decreto 582 de 2017: the deficiency response period is only 90 days (a practical estimate), and a single missed response is treated as a suspension. A recall handled late or sloppily therefore endangers the very asset that authorizes sales in the first place.

2. Legal basis

3. Expert insights

1. The power to launch sits with INVIMA; the duty to prepare sits with the company

The phrase executed under INVIMA directives settles the chain of command: whether to recall, the scope of the recall and the handling method are determined by INVIMA in its directive, and the company is responsible for execution and reporting. This does not license passivity — directives typically require an execution plan and a scope list within a very short time. GRZAN’s advice is to front-load the preparation: distribution records (which IPS facilities received which quantities), lists of points of use and notification templates must be maintained in ordinary times, not assembled by questioning distributors after the directive lands.

2. The two report types run on different rhythms, and the ledgers must be kept apart

Periodic reports are submitted quarterly (4 times per year); they are cycle-driven standing duties and should be filed even as zero reports when there are no events. Recall progress reports are event-driven: they start with the directive, advance with execution and close with the case. GRZAN maintains the two ledgers separately because their evidentiary functions differ — the quarterly report proves the system is operating, while the recall progress report proves the directive is being executed. Merging them makes it impossible to locate evidence quickly during verification.

3. Field corrective actions: compliant handling without product return

For units already installed, already implanted, or requiring on-site adjustment, retrofitting or relabeling at the healthcare facility, the company executes the field correction within the framework of the INVIMA directive and incorporates the handling results and evidence into the progress report. It must be clear that the specific corrective measure applied is decided by INVIMA’s case-by-case directive; the company should not choose the most convenient option for itself. GRZAN’s position is that while the choice of corrective measure does not rest with the company, the executability of the plan does — so upon receiving a directive, the company should respond as quickly as possible with a feasible plan.

4. Practical recommendations

1. Registration holder (titular): establish a recall SOP defining the full execution chain from receiving the directive to case closure: form the response team, submit the execution plan, notify through the channels, retrieve or correct in the field, file progress reports, close the case.
2. Importers: maintain distribution records covering UDI-DI, destination facilities, quantities and dates, updated quarterly.
3. Vigilance responsible person: submit periodic reports quarterly (including zero reports) and keep a recall progress ledger separate from them.
4. Vigilance responsible person: submit an executable plan immediately upon receiving a directive; do not decide the corrective measure unilaterally.
5. Quality and compliance leads: for implantable devices, maintain implant card records under Art. 40 down to the patient level.
6. Chinese manufacturers: for products listed as vital no disponibles, evaluate in advance the special import authorization path under Art. 48.

5. Verification checklist

• □ A recall SOP exists, covering the complete execution chain from receiving the directive to closure
• □ The importer maintains distribution records that include UDI-DI, updated quarterly
• □ The periodic report (quarterly) ledger and the recall progress ledger are maintained separately
• □ Notification templates and retrieval paths are ready and can be activated immediately upon receiving a directive
• □ Implantable devices have the Art. 40 implant card system implemented
• □ Recall closure records are archived as required under Ley 1437 de 2011 and can withstand ex-post verification

Regulatory information verified as of October 29, 2026

All conclusions published here defer to the current regulatory texts as issued by the competent authority, verified item by item before delivery.

— GRZAN Regulatory Team

GRZAN supports manufacturers on the Colombian market with the full post-market toolkit: recall planning and execution under INVIMA directives, field corrective actions, technovigilance reporting, and documentation systems built to survive follow-up controls and ex-post verification. To stress-test your recall readiness, contact the GRZAN regulatory team at info@grzanglobal.com.