Certificate of Free Sale for Medical Device Registration in Colombia

1. Key takeaways

The Certificado de Venta Libre, the free sale certificate (CFS), belongs to the legal document system of Article 19 of Decreto 4725 de 2005 (published December 26, 2005). Its function is to prove that a product is in lawful circulation in a given market. The GRZAN position is that in Colombia the CFS is evidence of market-access eligibility, not a substitute for technical compliance. Colombia grants no automatic recognition on the strength of a CE mark or an FDA approval, and no automatic certificate conversion mechanism exists.

The preparation order follows from this: the certificate of origin country is the backbone, and reference market evidence is an enhancer. The origin certificate answers whether the product is lawful in its home market; reference market certificates answer whether the product has been reviewed under mature regulatory systems. The two cannot replace each other, and a dossier that relies on one alone leaves an obvious gap that reviewers will find.

2. Legal basis

3. Expert insights

#### 1. Why treating a CE mark as a passport is a dangerous misjudgment

Under current Colombian law no provision equates a foreign approval with a local registration. The recurring pattern GRZAN observes in projects is an applicant filing a CE certificate as the core evidence while the technical documentation is carried over in EU format without localization, only to receive a deficiency at the Art. 18 technical documentation stage. A CE or FDA approval proves compliance in the original market; it does not prove that the INVIMA checklist has been answered. Since the official review timeline for standard registration is 90 working days and the deficiency response period is 90 days, with a single unanswered deficiency treated as a procedural suspension, the cost of treating the CE mark as a passport ultimately lands on those two clocks.

#### 2. The origin country CFS is the backbone, because it answers lawful marketing status

The object of proof of a CFS is that the product is in lawful circulation in the issuing country, and no approval from a third market can substitute for that statement. For manufacturers from the Chinese mainland the origin certificate is mandatory, not optional. Even then, if the issuing body’s template does not match what INVIMA expects, for instance by omitting the product name, the model, the manufacturer’s name or the legal basis of issuance, a request for clarification will still follow. The certificate must be read against the Colombian expectation before it is filed, not after the deficiency arrives.

#### 3. How to choose among five reference markets: regulatory maturity outweighs market size

As a practical estimate, GRZAN recommends prioritizing reference markets whose regulatory systems are mature and which carry mutual-recognition context for Colombia, such as the US FDA, EU authorities and Brazil’s ANVISA, supplemented where useful by approvals from neighboring Latin American regulators such as Mexico’s COFEPRIS or Argentina’s ANMAT as regional acceptability evidence. Two selection principles apply: first, the authority of the issuing body; second, the identity between the approval and the product under application. The model stated on the certificate must correspond exactly to the model under application, and it is better to file one fewer certificate than to file one whose model does not match.

#### 4. The draft decree direction deserves early preparation, but it cannot be relied on today

The published draft decree direction includes a mechanism for relying on the assessment results of foreign regulators such as the FDA, the EMA and ANVISA. The draft has completed international notification through the WTO with the comment period closed on July 17, 2026, but as of the verification date it has not been signed and published. GRZAN advises treating it as a documentation reserve: organize the reference market approvals now so they can be invoked the moment the mechanism takes effect, but do not write the reliance mechanism into the current submission strategy as a ground for reducing evidence. A draft has persuasive value in planning and none in filing.

4. Practical recommendations

1. Have the foreign manufacturer apply for a CFS from the competent authority of the country of origin, ensuring it states the product name, model, manufacturer name and address, and the legal basis of issuance.
2. Have GRZAN verify the identity between the product identification on the CFS and the product under application, removing any certificate whose model differs.
3. Have the applicant assemble the file as one origin certificate plus no more than 5 reference market approvals, ranked by regulatory maturity.
4. Have the translation vendor produce the official Spanish rendering of the CFS, without free translation of the issuing body’s name.
5. Have GRZAN maintain a CFS validity ledger, since most issuing bodies give the certificate a limited validity and an expired one must be reapplied for.
6. Have the registration specialist confirm before submission in SIRIS that the CFS and the other Art. 19 legal documents agree exactly on the manufacturer’s name and address.

5. Verification checklist

• □ The origin country CFS has been obtained and states the product name, model, manufacturer name and address, and the basis of issuance
• □ The product identification on the CFS is fully identical to the product under application, with no model discrepancy
• □ The CFS carries an official Spanish translation
• □ Reference market approvals do not exceed five and are ranked by regulatory maturity
• □ The model on every reference market certificate matches the model under application
• □ The assumption of automatic recognition based on CE or FDA approval has been excluded from the submission strategy
• □ The CFS and the other Art. 19 legal documents agree exactly on the manufacturer’s name and address

Regulatory information verified as of October 29, 2026

All conclusions for external use are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN supports manufacturers entering the Colombian market with registration dossiers and conformity documentation, including CFS strategy, reference market evidence selection, official Spanish translation coordination and complete Art. 19 legal dossier assembly before INVIMA. For inquiries, contact info@grzanglobal.com.