Colombia: Automatic vs Standard Registration Under Decreto 4725

1. Key takeaways

In Colombia, the registration pathway is not a filing strategy but a statutory allocation of devices by risk class. Article 16 of Decreto 4725 de 2005 locks Class IIb/III devices into the Registro Sanitario (standard registration), while Article 17 locks Class I/IIa devices into the Registro Sanitario Automático (automatic registration). The applicant has no discretion to select between the two pathways. What can genuinely be chosen is the risk class assigned to the product, and that determination is derived from the classification criteria of Article 6 and the 18 classification rules of Article 7. It cannot be reasoned backwards from a desired launch date or a preferred commercial timeline.

The official-fee gap between the two pathways is almost negligible: under the 2026 fee schedule, Class I/IIa registration costs 321.91 UVB (approximately COP 3,898,330), while Class IIb/III registration costs 364.36 UVB (approximately COP 4,413,000), a difference of roughly 42.45 UVB. The real divergence lies in time and documentation depth. The official review period for automatic registration is 2 business days, whereas standard registration carries 90 business days, excluding deficiency-response round trips. GRZAN’s judgment is direct: treating down-classification as a cost-reduction lever is the most common starting point of failure in Colombian projects, because the rework caused by a misclassification costs far more than the few dozen UVB separating the two pathways.

2. Legal basis

3. Expert insights

#### The very idea of pathway choice is a misreading

Articles 16 and 17 are not two parallel application formats; they are two legal consequences allocated by risk class. The wording of the provisions is applies to, not may choose. GRZAN repeatedly encounters one misconception in projects: the company first fixes a desired certificate date and then asks to file the product as Class I. This does not hold legally. Classification is the precondition for applying a provision, not a product of that application. Once the classification conclusion is formed, the pathway follows automatically, and the administrative procedure does not accept a pathway switch justified by commercial reasons.

#### Two business days buy acceptance, not approval

The 2 business days period of automatic registration is often read as a certificate in two days. Read together with Article 57 of Ley 962 de 2005, however, that period corresponds to formal verification and issuance actions, and substantive technical review is shifted to after issuance. Article 17 exempts prior technical review, not the compliance obligations themselves. Companies that conflate the two concepts typically expose problems in the post-issuance follow-up controls, where the consequence is no longer a deficiency letter but cancellation and liability proceedings.

#### Similar fees, an inverted cost structure

On the surface, Class IIb/III pays only about 42.45 UVB more than Class I/IIa. But the technical document list in Article 18 must be fulfilled to a completely different depth on the two pathways. Standard registration requires the technical dossier to be built to a state where a reviewer can interrogate every item; any item hit by a requerimiento opens the 90-day deficiency window, during which the statutory clock is suspended and the real timeline stretches accordingly. Measured on a project basis, GRZAN finds that the true investment for Class IIb/III runs at a multiple of Class I/IIa, and official fees are a minor share. What determines cost is dossier preparation quality and the number of deficiency rounds, not the fee rate.

#### The dividing line is being redrawn

The draft Proyecto de Decreto on the Régimen Sanitario de Dispositivos Médicos would replace the current two-tier structure with three authorization tiers: notificación sanitaria, registro sanitario and permiso de comercialización, and would change the validity period from 10 years to indefinite, tied to post-market performance. The draft was published in January 2026 (about 16 chapters and 180 articles), went through WTO international notification on May 18, 2026, closed its comment period on July 17, 2026, and itself proposes an 18-month transition period. As of the verification date it has not been signed or promulgated, and Decreto 4725/2005 remains in force. GRZAN’s recommendation: file current projects under the existing two-tier structure, but reserve interfaces in the dossier architecture for migration to the three-tier regime.

4. Practical recommendations

1. At project initiation, the GRZAN regulatory team issues a classification determination memo that walks through every criterion of Art. 6 and all 18 rules of Art. 7, producing a traceable written conclusion that serves as the foundational document for all subsequent filing actions.
2. The Colombian legal representative (apoderado / representante legal) designated by the titular completes holder confirmation and account permission configuration on SIRIS; foreign manufacturers may not file directly.
3. Finance builds the budget on the 2026 fee schedule: Class I/IIa at 321.91 UVB, Class IIb/III at 364.36 UVB, and separately reserves modification fees — a modification of legal nature at COP 826,546 and of technical nature at COP 1,060,243.
4. The project manager builds the reverse timeline on the Class IIb/III statutory period of 90 business days plus the 90-day deficiency window, and never promises external delivery dates on the statutory period alone.
5. After certificate issuance, the registration team verifies the particulars listed in Art. 20 (titular name and address) and initiates renewal at least 3 months before expiry.
6. The strategy function tracks signature and promulgation milestones of the new draft decree and assesses transition arrangements for existing certificates moving from the two-tier structure to the three-tier authorization regime.

5. Verification checklist

• □ A written classification determination covering Art. 6 and all 18 rules of Art. 7 has been issued
• □ It has been confirmed that the product does not fall within the exclusions of Art. 1 (custom devices; in vitro diagnostic reagents follow Decreto 3770 de 2004 separately)
• □ Technical and legal document lists have been separated per Art. 18 and Art. 19, with Spanish originals or official translation status flagged
• □ The power of attorney (POA, Art. 29) linking the titular and the local apoderado is valid and duly legalized
• □ UVB and COP amounts have been checked against the 2026 fee schedule, with modification fees reserved
• □ For Class IIb/III, the timeline has been built backwards on 90 business days plus the 90-day deficiency window
• □ The titular name and address stated under Art. 20 on the certificate match the business license

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 supports manufacturers entering the Colombian market with INVIMA registration pathway selection and classification strategy services, from risk-class determination under Decreto 4725 de 2005 through dossier architecture, fee budgeting and timeline modeling, so that every filing decision is anchored in the correct legal basis. For inquiries, contact info@grzanglobal.com.