InvimÁgil Digital Platform: What It Means for Medical Device Companies

1. Key takeaways

Resolución 2025029237 adopted a competition-oriented regulatory model and launched the InvimÁgil digital platform on a phased rollout. The platform went live on May 8, 2025 with food and alcoholic beverage registrations as the first procedures; cosmetics and other categories belong to a second phase; and the medical device module belongs to a later phase and, as of the verification date, has not yet opened.

GRZAN’s advice to companies is direct: do not change your filing path now — all medical device and IVD submissions continue to go through SIRIS. The substantive impact of InvimÁgil on device companies today is zero; its future substantive impact lies in data preparation — once the device module opens, structured technical documentation, semantic coding and CCAA data will determine filing efficiency. Moving the preparation work forward matters more than waiting for the platform.

2. Legal basis

3. Expert insights

1. Devices were not in the first wave: do not read the platform is live as devices are live

The public statements that InvimÁgil is in operation refer to the first wave launched on May 8, 2025, covering food and alcoholic beverage registrations. Reading that as devices can now report to the new platform is the most common distortion in this round of coverage. GRZAN’s standard answer to client inquiries is: the platform being live does not equal the device module being live; the device module belongs to a later phase, has not opened, the current filing path is unchanged and remains SIRIS (siris.invima.gov.co), and the submitting party remains the titular del registro.

2. The sequencing is easiest first, and devices come later precisely because they are the hardest

The logic of the phased rollout is increasing data complexity. The registration elements of food and alcoholic beverages are relatively standardized; devices stack technical documentation (Art. 18), legal documentation (Art. 19), risk classification, the CCAA (Resolución 4002 de 2007) and, after February 8, 2026, the fully mandatory semantic coding and UDI-DI (Resolución 1405 de 2022). Unless these four data groups are structured, the platform cannot carry the device business. GRZAN’s judgment is that the precondition for the device module going live is precisely the set of compliance actions companies must complete around 2026 — the two are two faces of the same thing.

3. Digitization improves routing, not review intensity

The experience of Circular Externa 100-0361-16 with Class I/IIa automatic renewal is instructive (the single window cut turnaround from about 30 days to about 3 business days, a practical estimate): digitization improves the routing steps and does not change review standards. Under the official review timelines, automatic registration takes 2 business days and standard registration 90 business days, and neither is automatically shortened by a platform change; the deficiency response period remains 90 days (a practical estimate), with a single missed response treated as a suspension. GRZAN reminds clients not to compress their own document preparation cycles because a new platform has appeared.

4. Practical recommendations

1. Regulatory affairs leads: continue submitting all medical device and IVD applications through SIRIS; do not wait for InvimÁgil and do not pause existing project schedules.
2. Regulatory affairs leads: rely solely on official INVIMA announcements to confirm the status of the device module; do not accept secondhand reports.
3. Chinese manufacturers: digitize and structure the technical documentation (Art. 18) and legal documentation (Art. 19), with unified versioning.
4. Regulatory affairs leads: complete semantic reporting and UDI-DI assignment under Resolución 1405 de 2022 before the device module opens.
5. Importers: keep the CCAA valid (5 years) and request re-inspection at least 5 business days before expiry.
6. Chinese manufacturers: budget at the current rates of Resolución 2025067543 (Class I/IIa 321.91 UVB, Class IIb/III 364.36 UVB, marketing authorization for controlled technical equipment 367.92 UVB).

5. Verification checklist

• □ It has been confirmed that the first InvimÁgil wave covered food and alcoholic beverage registrations and the device module has not yet opened
• □ It has been confirmed that the current filing path remains SIRIS and the submitting party is the titular del registro
• □ The status of the device module has been confirmed through official INVIMA announcements rather than secondhand reports
• □ Technical documentation (Art. 18) and legal documentation (Art. 19) have been digitized with unified versions
• □ Semantic reporting and UDI-DI assignment under Resolución 1405 de 2022 have been completed
• □ The importer’s CCAA is within its validity and re-inspection is scheduled using the 5-business-day lead time

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 tracks INVIMA’s digital transformation on behalf of device manufacturers and provides post-market compliance support for the Colombian market: SIRIS filings, semantic reporting and UDI-DI implementation, CCAA management, technovigilance, recalls and inspection readiness. For a clear view of what InvimÁgil means for your portfolio, contact the GRZAN regulatory team at info@grzanglobal.com.