Product Liability for Medical Devices in Chile

1. Key takeaways

Obtaining the ISP sanitary registration certificate does not constitute a ground for exemption from civil or administrative liability. The certificate answers whether a product may be placed on the market; it says nothing about who pays after an incident. In Chile, harm caused by a defective device can simultaneously trigger administrative liability (handled by SEREMI under the sanction provisions of the Sanitary Code) and civil liability (asserted under the consumer protection law and general civil rules).

GRZAN stresses one rule of practice: the speed of the tecnovigilancia and recall response usually determines the final size of the liability more than the registration certificate itself. An authority assessing sanctions and a court assessing damages both weigh how the company behaved once the risk surfaced — whether events were reported on time, whether the recall moved quickly, whether records exist to prove it. A clean certificate attached to a slow, undocumented response produces the worst outcome, while a fast, well-documented response materially limits exposure even when the product was defective. Post-market conduct is therefore not a compliance formality but the company’s principal liability-management instrument, and it should be resourced and rehearsed accordingly.

2. Legal basis

• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter f) | sale or distribution without a quality certificate is subject to seizure; Article 111 letter e) | SEREMI’s power to open cases and impose sanctions; Article 174 | sanction provisions (magnitudes per the current text).
• Consumer protection law | Ley N° 19.496 | product liability and information duties | liability and remedies within the consumer protection framework.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 28: post-market reporting obligations; Article 30: seizure of products sold or distributed without a certificate.
• General Technical Norm on patient safety and the safe use of medical devices | Norma General Técnica N° 204 | published January 16, 2019 | tecnovigilancia duties.
• ISP public consultation | National Tecnovigilancia System Guide | August 27, 2026 | FSCA and recall duties (proposed).

3. Expert insights

Insight one: administrative liability and civil liability are two separate lines, and the registration certificate is no defence to either.

The administrative line is led by SEREMI, with measures including fines, suspension of business, revocation of authorisations, suspension of sale and use, and recalls; the civil line is pursued by injured parties under consumer protection rules. Holding the registration certificate only shows that the formal market-access requirements were met; it does not influence the liability analysis on either line. Companies that conflate market access with risk transfer discover the distinction at the least convenient moment — after an incident, when both proceedings start independently.

Insight two: information duties are the core of consumer protection law, and labelling and instructions are the vehicle of those duties.

Consumer protection law imposes explicit information duties on suppliers. Article 26 and Article 2 numeral 14 of DS 825/1998 anchor labelling, instructions for use and intended use as the manufacturer’s instructions — the two sets of rules coincide exactly on the question of whether information is sufficient and accurate. Labelling that overstates the intended use, or instructions that are missing, breaches both regimes at once, which is why label text is a liability document as much as a regulatory submission.

Insight three: tecnovigilancia records are the decisive evidence in liability assessment.

The reporting records under Article 28 of DS 825/1998 and Norma N° 204 — investigation records, risk assessments, and recall reconciliation records — serve both as compliance evidence and as evidence for the defence of liability claims. Conversely, failure to report or late reporting becomes an aggravating factor in the liability analysis. The same file that satisfies the ISP is the file a civil court will read; it should be built to serve both readers.

Insight four: the licence holder is one link in the liability chain, and manufacturers cannot stand aside.

Article 111 of the Sanitary Code brings manufacturing, import, sale and distribution alike under supervision. If the licence holder or importer is sanctioned, the channel breaks immediately, and the brand-level losses are borne by the manufacturer — the worst-case scenario of leaving the certificate in the distributor’s name. Manufacturers should therefore treat the financial and operational health of the licence holder as part of their own risk management.

4. Practical recommendations

1. Never suggest in marketing that ISP registration means no risk; such claims may themselves constitute a breach of information duties and are easily quoted back in later proceedings.
2. Manage labelling and instructions for use as the core vehicle of information duties, with the intended use stated narrowly and factually.
3. Keep tecnovigilancia and recall records complete: reports, investigations, risk assessments and reconciliations, forming a defence evidence chain that can be produced as a whole.
4. State recall cooperation and cost sharing in distribution agreements, so the response is never held hostage to commercial negotiation during an event.
5. Pre-plan channel continuity for administrative measures (suspension of sales, revocation of authorisation) to limit the knock-on losses that follow when the licence holder is sanctioned and liability cascades across the chain.

5. Verification checklist

• □ Marketing materials contain no registration-equals-immunity claims
• □ Labelling and instructions have been reviewed against information-duty standards
• □ Tecnovigilancia and recall records are kept in full
• □ Distribution agreements state recall cooperation and cost sharing
• □ A channel continuity plan for suspension of sales and revocation of authorisation is in place

Regulatory information verified as of October 29, 2026.

GRZAN supports manufacturers, importers and authorised representatives with post-market compliance in Chile, including tecnovigilancia reporting, FSCA and recall execution, record-keeping systems and SEREMI inspection response. For a product-specific feasibility assessment or post-market compliance support for the Chilean market, contact the GRZAN regulatory team at info@grzanglobal.com.