Colombia Draft Unified Device Decree: Timeline and Key Changes

1. Key takeaways

The Colombian MSPS is advancing a unified decree draft named Régimen Sanitario de Dispositivos Médicos, aiming to comprehensively update Decreto 4725 de 2005 and Decreto 3770 de 2004. The timeline is now clear: the final report of the ex-ante regulatory impact analysis (AIN) was published in November 2025; the draft was released publicly in January 2026 with roughly 16 chapters and 180 articles; the WTO international notification was made on May 18, 2026; and the WTO international comment period closed on July 17, 2026.

Three changes matter most to Chinese manufacturers: the authorization model shifts from a registration certificate plus permit to a three-tier structure of notificación sanitaria, registro sanitario and permiso de comercialización; validity changes from 10 years to indefinite, tied to post-market performance; and UDI requirements move forward to the first application. The draft proposes an 18-month transition period. The GRZAN regulatory team’s judgment is that, as of the verification date, the draft has not been signed or published and Decreto 4725 de 2005 and Decreto 3770 de 2004 remain the laws in force — companies should continue filing under current law while reserving document interfaces for the transition.

2. Legal basis

3. Expert insights

#### The three-tier authorization model is essentially a reallocation of regulatory resources by risk

The draft splits authorization into three tiers: notificación sanitaria (health notification), registro sanitario (health registration) and permiso de comercialización (marketing permit). This is not a simple renaming — it demotes the lowest-risk products from approval to notification and concentrates regulatory resources on medium- and high-risk products and controlled-technology equipment. The GRZAN regulatory team’s judgment is that, once in effect, the entry barrier for Class I products will fall further, while the depth of technical review for Class IIb/III may rise rather than fall, because review capacity saved at the low end will be reinvested in high-risk products. Companies should adjust expectations accordingly: accelerate distribution for low-risk products and prepare more complete clinical and performance evidence for high-risk ones.

#### Indefinite validity replaces renewal management with post-market performance management

Under the current regime, device certificates are valid for 10 years, counted from the administrative act granting them, with renewal starting at least 3 months before expiry. The draft replaces this with indefinite validity tied to post-market performance. The substance of the change is swapping periodic review for continuous supervision: companies will no longer have the rhythm of assembling materials in bulk before expiry, but must sustain the quality of vigilance, change submissions and adverse event reporting over the long term. The GRZAN judgment is that this is a risk rather than a benefit for companies with weak compliance systems — indefinite validity means the regulator can trigger suspension or cancellation at any time based on post-market performance, instead of settling accounts only at renewal.

#### The forward shift of UDI and the explicit naming of ISO 13485 are homework that can start now

The draft moves UDI requirements to the first application and explicitly names ISO 13485 as the device GMP standard. Neither requires waiting for the draft to be signed: Resolución 1405 de 2022 already established the semantic standard and UDI-DI requirements, and on March 12, 2026 INVIMA confirmed the transition period had ended with the semantic report fully mandatory; ISO 13485 is a certificate most Chinese manufacturers already hold. The GRZAN regulatory team recommends building these two items into a foundation that works under both the old and the new framework, so nothing needs rework regardless of when the draft is signed.

4. Practical recommendations

1. The GRZAN regulatory team tracks how the draft text evolves after the WTO comment period, focusing on comparing the product scope and risk thresholds assigned to each tier of the three-tier authorization model.
2. Continue filings under current law and do not pause in-flight projects because of the draft — Decreto 4725 de 2005 and Decreto 3770 de 2004 remained in force as of the verification date.
3. Complete UDI-DI coding and the semantic report early (Resolución 1405 de 2022) so they can be submitted at the first application stage, matching the draft’s forward-shifted UDI requirement.
4. Verify the scope and validity of the ISO 13485 certificate, ensuring it covers the products to be filed and their production sites, as the GMP evidence base under the draft.
5. Build a continuous record of post-market performance (vigilance, changes, complaints, recalls) to prepare for continuous supervision under indefinite validity.
6. Inventory existing certificates and predict, by risk class, where each falls in the three-tier model, prioritizing conversions for the 18-month transition period.
7. Have the local legal representative (apoderado) maintain an open communication channel with INVIMA throughout the transition and promptly obtain the official position on existing certificates.

5. Verification checklist

• □ The draft timeline has been recorded: 2025-11 AIN, 2026-01 draft, 2026-05-18 WTO notification, 2026-07-17 comment deadline
• □ It has been confirmed that as of the verification date the draft is unsigned, with current law still Decreto 4725 de 2005 and Decreto 3770 de 2004
• □ In-flight projects are proceeding under current law and were not paused on account of the draft
• □ UDI-DI coding and the semantic report have been completed and can be submitted at the first application stage
• □ The scope and validity of the ISO 13485 certificate have been verified
• □ A continuous record of post-market performance has been established
• □ Existing certificates have been inventoried and prioritized for the 18-month transition period by risk class

Regulatory information verified as of October 29, 2026

All outward-facing conclusions are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN provides end-to-end INVIMA registration and compliance support for manufacturers entering the Colombian market, covering regulatory monitoring of the unified decree draft, transition planning, UDI and semantic reporting and post-market performance management. For inquiries about INVIMA registration in Colombia, contact info@grzanglobal.com.