Penalties for Unregistered Device Sales: Seizure, Fines and Liability in Chile

1. Key takeaways

In Chile, devices that should be registered may not be manufactured, imported, sold or distributed without registration. The consequences of a violation come in three layers. At the product level: devices sold or distributed without a conformity verification certificate are seized (decomiso). At the administrative level: the SEREMI of the region where the violation occurred opens a case and imposes sanctions; under the penalty provisions of the Sanitary Code, these can include fines, closure of the business, revocation of authorizations, suspension of sale and use, and recalls. At the civil level: injured parties may claim damages under general civil liability and consumer protection rules, and holding a registration certificate is not a defense.

For the manufacturer, the real loss is usually not the fine but the interruption of the distribution channel and the collateral damage to the brand. A fine is a line item; a suspended product line is a market position surrendered, a distributor network that reroutes to competitors, and a customer base that associates the brand with an enforcement action. Risk planning should therefore weight the conduct-type measures far more heavily than the monetary ones, because those are the measures that change what the company is able to sell the following quarter. The three layers also operate independently, so a single violation can produce a seizure, a sanction and a damages claim at the same time.

2. Legal basis

The following sources govern unregistered sales and the enforcement toolkit:

• Sanitary Code of Chile (Código Sanitario) | DFL N° 725, de 1967 | Article 111(f) | devices sold or distributed without the quality certificate required by this Article are seized, without prejudice to other measures the health authority may take.
• Same instrument | Article 111(e) | the SEREMI of the region where the violation occurred is responsible for opening the case (sumario sanitario) and imposing sanctions.
• Same instrument | Articles 111(a) and 111(g) | the verification obligation and the authorization of use and disposition.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 30: devices sold or distributed without a conformity verification certificate are seized; Articles 1 and 3: the prior verification obligation.
• Sanitary Code | Article 174 | penalty provisions (fine ranges follow the current text; in practice, SEREMI decides case by case).
• Consumer protection law | Ley N° 19.496 | product liability and information duties (a registration certificate is not a shield against liability).

3. Expert insights

Insight 1: seizure is conduct-based; no actual harm is required.

The wording of Article 111(f) of the Sanitary Code and Article 30 of Decreto Supremo N° 825, de 1998 is sale or distribution without a certificate, and seizure follows. No health damage needs to have occurred. This means the risk crystallizes at the moment the goods are placed on the market, not when something goes wrong. A product that performs perfectly for years can still be seized today for the absence of a certificate years ago, because the violation is the act of selling, not any consequence of the product. There is no grace period and no harm threshold to hide behind. For importers and distributors this changes the calculus: the certificate status of every product must be verified before the first unit ships.

Insight 2: fines are decided by the SEREMI case by case, and usually come with conduct-type measures.

The penalty provisions of the Sanitary Code authorize measures beyond fines, including closure, revocation of authorizations, suspension of sale and use, and recalls. For a manufacturer, a suspension of sales is more lethal than a fine, because it cuts the channel directly. Fines are bounded, budgetable and insurable; a suspension is none of those things. Enforcement planning therefore focuses on the conduct measures: what triggers them, how quickly they can be lifted, and what evidence of cooperation shortens them. The measures can also be combined, so a fine and a suspension are not alternatives but a package.

Insight 3: the enforcement authority is the SEREMI, not the ISP.

Article 111(e) assigns case-opening and sanctioning powers to the SEREMI of the region where the violation occurred. This means a company with national distribution may face different enforcement paces across several regions, and response plans must be prepared region by region. One region may open a sumario sanitario while another has not yet acted, producing inconsistent timelines for the same product. A single national template answer is not enough: each regional SEREMI needs a contact person and a prepared documentation package of its own. Regional coordination, through one internal owner who tracks every open case, keeps the responses consistent.

Insight 4: a registration certificate is not a liability shield.

Holding an ISP registration only evidences that market access requirements were met; it does not extinguish product liability. Injured parties can still claim under the consumer protection rules of Ley N° 19.496. GRZAN highlights in every project: the speed of technical vigilance and recall response directly determines the size of the civil liability. A fast, documented response limits the number of affected units and the number of exposed patients; a slow response multiplies both, and with them the damages.

4. Practical recommendations

1. Write the no-distribution-without-registration rule into the distribution agreement, and allocate seizure losses contractually.
2. Prepare SEREMI response plans region by region: designate local contact persons and prepare standard reply templates and documentation packages.
3. Establish batch traceability, so that a problem can be confined to specific batches instead of the whole warehouse being seized.
4. Cover conduct-type measures in the response plans: not only fines, but above all the workflows for suspension of sales and recalls.
5. Make vigilance and recall response speed a compliance KPI, as the first line of defense controlling civil liability risk.

5. Verification checklist

• □ The distribution agreement includes the no-distribution-without-registration rule and allocation of seizure losses
• □ SEREMI response plans and contact persons exist region by region
• □ Batch traceability has been established
• □ The plans cover conduct-type measures such as suspension of sales and recalls
• □ Vigilance and recall response deadlines are included in compliance KPIs

Regulatory information verified as of October 29, 2026.

GRZAN supports medical device manufacturers entering the Chilean market with end-to-end services covering the local license holder and importer setup, enforcement-readiness and SEREMI response planning, and fee and budget planning under the current ISP arancel. Whether you need a compliance risk review, a cost model for your product class, or hands-on filing support through GICONA, our regulatory team is ready to help. Contact us at info@grzanglobal.com.