Colombia INVIMA Filing Timeline Planning and Deficiency Rounds

1. Key takeaways

The statutory review period for a Class IIb/III filing in Colombia is 90 business days, but that figure describes only the segment during which the reviewing authority works; deficiency round trips are not counted within it. The deficiency response period itself is 90 days (public sources vary between calendar days and business days; GRZAN treats this on a practical-estimate basis). The correct scheduling model is therefore not a certificate in 90 business days, but rather 90 business days of authority review, plus a 90-day applicant response per deficiency round, plus a fresh round of authority review after each response.

GRZAN sets three scheduling disciplines: first, external commitments give ranges, never a single figure; second, deficiencies are reserved for as a default event, not treated as an exception; third, time costs outside the statutory period — Spanish translation, power of attorney legalization, UDI and semantic reporting, importer CCAA — are modeled alongside. One further constraint applies: registration certificates are valid for 10 years from the date of the administrative act of grant, and renewal must start at least 3 months before expiry — the certificate management timeline is maintained separately from the filing timeline.

2. Legal basis

3. Expert insights

#### The statutory period binds the authority, not your delivery date

The figure of 90 business days was set for INVIMA by Decreto 582 de 2017, and its legal effect is a constraint on the authority — the authority should complete its review actions within that period. It is not a delivery commitment to the applicant. GRZAN never writes the statutory period directly into contracts or project plans as a delivery date, because both ends of that number are clamped by other clocks: upstream, material preparation, translation and legalization; downstream, deficiency round trips. Treating an institutional obligation as a project timeline is the most expensive cognitive error in scheduling.

#### Deficiencies belong in the baseline plan, not the risk register

The deficiency response period is 90 days, and failure to respond within it is treated as a suspension of the application. In practice, deficiencies trigger frequently, and the triggers concentrate in consistency gaps between documents. GRZAN’s schedule model builds in at least one deficiency round — authority review, deficiency notice, 90-day response, and resumed authority review as one complete cycle unit. If no deficiency actually occurs, the project lands early; if two rounds occur, the model still holds. Excluding deficiencies from the baseline plan means treating the most probable event as a black swan.

#### Non-review time costs are systematically underestimated

What schedules usually omit is not the review but everything around it: execution and legalization of the power of attorney (Art. 29), Spanish translation of all documents, UDI-DI and GMDN semantic reporting under Resolución 1405 de 2022, and importer CCAA validity (5 years, with renewal inspection filed 5 business days in advance). These items run in parallel with or ahead of review, and any one of them stalling prevents the 90 business days clock from ever starting. GRZAN turns each of them into an independent milestone tracked separately from review nodes.

#### Platform and regime changes shift timing, but schedule on current law

The InvimÁgil digital platform launched under Resolución 2025029237 went live on May 8, 2025 with food and alcoholic beverage registrations as the first module, and the medical device module opens in later phases; current filings are still submitted through SIRIS by the titular del registro. The draft new decree would move UDI requirements forward to first application, make validity indefinite, and propose an 18-month transition period; as of the verification date it has not been signed or promulgated. GRZAN’s scheduling principle: plan on current law and current systems, while reserving an observation window for platform switching and decree updates — never build a plan on expectations that have not entered into force.

4. Practical recommendations

1. At the project kickoff, the GRZAN regulatory team delivers a schedule model sheet that lists authority review (90 business days), deficiency response (90 days per round), material preparation, translation and legalization, UDI and semantic reporting, and CCAA as independent milestones.
2. The project manager models at least one deficiency round and annotates the premise that the statutory period excludes deficiency round trips.
3. Sales and market teams make external commitments only in ranges and never cite the single statutory period figure.
4. The titular’s local apoderado completes the power of attorney (Art. 29) and Spanish document preparation before formal submission, ensuring the review clock can start.
5. Compliance completes UDI-DI and GMDN semantic reporting under Resolución 1405 de 2022 before submission, so these never become an upstream blocker.
6. The registration team maintains the certificate timeline separately: validity of 10 years from the administrative act of grant, with renewal starting at least 3 months before expiry.

5. Verification checklist

• □ The schedule model lists authority review, deficiency response, material preparation, translation, UDI and other independent milestones
• □ The plan annotates the premise that the 90 business days exclude deficiency round trips
• □ The model builds in at least one deficiency round, without a single 90-business-day figure
• □ External commitments use ranges and never cite a single statutory period
• □ The power of attorney (Art. 29) and Spanish documents are ready, so the review clock can start
• □ UDI-DI and GMDN semantic reporting is complete and does not block the front end
• □ The certificate timeline is built on the 10-year validity and the 3-month pre-expiry renewal window
• □ The importer’s CCAA is valid and the renewal inspection date is scheduled

Regulatory information verified as of October 29, 2026

All external conclusions rest on the current regulatory texts published by the competent authority, verified provision by provision before delivery.

GRZAN builds INVIMA filing timelines for the Colombian market that hold up against deficiency rounds, translation lead times and certificate renewal windows, so market-entry commitments survive contact with the administrative process. For inquiries, contact info@grzanglobal.com.