Chile Tecnovigilancia under Norma General Técnica N° 204

1. Key takeaways

The current institutional foundation of tecnovigilancia for medical devices in Chile is Norma General Técnica N° 204 (on the safe use of medical devices for patient safety and healthcare quality: tecnovigilancia), issued by the Ministry of Health (MINSAL). It was issued on December 21, 2018 and published in the Official Gazette on January 16, 2019. The norm establishes a national tecnovigilancia network that operates at three levels — national, territorial, and local — and requires a designated tecnovigilancia responsible person at each level. This tiered architecture matters for companies because it defines how event information moves through the system, how quickly it reaches the national level, and which counterpart a company should expect to deal with when a query or a report is circulating.

GRZAN highlights one point that is frequently misread: the scope of tecnovigilancia covers all devices and IVDs present on the domestic market, not only the product categories subject to mandatory registration. Chile brings product categories into registration control one by one, so many devices can lawfully be sold without a registration certificate. That permissive registration logic does not carry over into vigilance. Whether or not a product needs to be registered, once it is on the Chilean market it sits inside the tecnovigilancia system, and the reporting duties attached to it apply in full.

The practical conclusion is straightforward: build the vigilance file for the entire portfolio that is actually sold in Chile, and treat Norma General Técnica N° 204 as the operating baseline while the successor guide is still in draft.

2. Legal basis

• General Technical Norm on patient safety and the safe use of medical devices | Norma General Técnica N° 204 | issued December 21, 2018, published in the Official Gazette January 16, 2019 | Establishes the national tecnovigilancia network (three-level operation: national, territorial, local); requires designation of a tecnovigilancia responsible person at each level; healthcare institutions must report incidents and adverse events related to device use, prioritizing adverse events and sentinel events involving critical medical equipment.
• 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.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter e) | SEREMI’s power to open cases and impose sanctions (this is the hook that connects enforcement to the territorial level of the network).
• ISP public consultation | National Tecnovigilancia System Guide | launched August 27, 2026, consultation period until September 27, 2026 | intended to replace previous versions (as of the verification date this remains a draft, pending verification).

3. Expert insights

Insight one: the three-level network determines the direction of reporting flow, not only the recipient.

Each of the three levels — national, territorial, and local — has its own tecnovigilancia responsible person, and each acts as the single communication channel for its tier. In practice this means a report may start at a hospital, travel upward from the local level to the territorial level, and only then consolidate at the national level; alternatively, a company may report directly to the national level (ISP). Both routes exist, and which one is actually used affects how much delay and distortion the information suffers on the way. Understanding the flow is what allows a company to judge the risk of late or degraded information — for example, when an incident surfaces at a clinic weeks before the company hears about it. Mapping the flow is therefore a planning exercise, not trivia.

Insight two: healthcare institutions are the primary reporting subjects, but manufacturers cannot stand aside.

The primary obligation holders under Norma N° 204 are healthcare providers — public, private, military, and police-force institutions. Yet Article 28 of DS 825/1998 simultaneously imposes reporting duties on the importer or the manufacturer. These are two parallel lines of obligation, not a single chain in which one actor can satisfy the other. A manufacturer cannot justify silence by assuming that the hospital will report. If the institution fails to report, delays, or reports incompletely, the manufacturer’s own duty remains unfulfilled, and the exposure sits with the licence holder and the manufacturer.

Insight three: the scope covers every product on the market, not only controlled categories.

Chile uses a category-by-category inclusion model, and categories not yet included require no registration. Tecnovigilancia does not follow that logic. The norm applies to all devices and IVDs on the domestic market, registered or not. This is the textbook case of no registration requirement does not mean no obligations. Companies with unregistered products in Chile often discover this late, during an inspection or after an incident, when the absence of any vigilance file becomes an aggravating factor rather than a neutral fact.

Insight four: Norma N° 204 is being revised and replaced.

The ISP opened a public consultation on the National Tecnovigilancia System Guide on August 27, 2026, and the draft is intended to replace previous versions. As of the verification date of October 29, 2026, the document is still a draft and has not entered into force, so the Norma N° 204 system continues to apply. Article 42 in this series examines the draft in detail. Until the final guide is published, companies should treat the draft as a planning signal, not as current law.

4. Practical recommendations

1. Build the tecnovigilancia ledger on the basis of all products on the market, not only the registered categories. The ledger should capture device identifiers, batch or serial traceability, distribution channels, and the local contact through which event information is expected to arrive.
2. Understand the three-level flow and designate a counterpart on the Chilean licence-holder side, so that queries coming up from the local level are received and answered inside the applicable time limits rather than sitting unanswered in a hospital inbox.
3. Do not push all reporting duties onto healthcare institutions: Article 28 of DS 825/1998 creates an independent obligation for the importer or manufacturer, and it is enforced on its own terms.
4. Track the publication of the final National Tecnovigilancia System Guide and update internal time limits immediately once it enters into force, so the transition is a switch rather than a rebuild.
5. Bring distributors into the tecnovigilancia system: state in agreements the time limit within which adverse event information must be transmitted back to the manufacturer, and verify compliance periodically.

5. Verification checklist

• □ A tecnovigilancia ledger has been built covering all products on the market
• □ The three-level network flow has been mapped and a designated counterpart is in place
• □ The independent reporting duty under Article 28 of DS 825/1998 has been confirmed
• □ A tracking mechanism exists for publication of the final National Tecnovigilancia System Guide
• □ Distribution agreements state the time limit for transmitting adverse event information back

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.