Article 28 of DS 825/1998: Post-Market Reporting in Chile

1. Key takeaways

Article 28 of DS 825/1998 establishes the two-directional reporting structure of Chile’s post-market obligations: healthcare institutions must report device defects, malfunctions and performance degradation, as well as missing labelling or instructions for use that cause or may cause patient death or harm to health; importers or manufacturers must report the technical or medical reasons leading to a systematic recall.

The provision has been in force since its publication on August 21, 1999 and is a current, legally effective statutory duty. It runs in parallel with the tecnovigilancia guide that is still in consultation — the relationship is parallel, not one of replacement. That distinction matters operationally: the guide, even once final, will not absorb or neutralise Article 28, and the two obligations will continue to be assessed independently. A compliance programme that maps only the vigilance-guide duties while treating the regulation-level duty as historical background will leave a live statutory obligation uncovered. GRZAN therefore treats Article 28 as the fixed statutory backbone of Chilean post-market reporting, around which the operational detail of the guide is arranged.

2. Legal basis

• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 28: healthcare institutions must report device defects, malfunctions and performance degradation, as well as missing labelling or instructions for use that cause or may cause patient death or harm to health; importers or manufacturers must report the technical or medical reasons leading to a systematic recall.
• Sanitary Code | DFL N° 725, de 1967 | Article 111 letter e) | SEREMI’s power to open cases and impose sanctions; Article 111 letter f) | 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 | reporting duties of healthcare institutions and the three-level network.
• ISP public consultation | National Tecnovigilancia System Guide | August 27, 2026 | proposed duties of manufacturers, importers and distributors (not in force as of the verification date).

3. Expert insights

Insight one: the two lines of Article 28 have different trigger conditions.

The healthcare-institution line is triggered by patient harm that has occurred or may occur (including harm caused by missing labelling or instructions); the importer/manufacturer line is triggered by the technical or medical reasons leading to a systematic recall. The former is event-driven; the latter is cause-driven. A single product problem can therefore activate one line without the other, or both at once: a defect causing harm is an event for the institution, while the same defect’s root cause, once it forces a systematic recall, becomes a reportable reason for the manufacturer. Compliance mapping must cover both triggers separately rather than assuming one report discharges both.

Insight two: missing labelling or instructions for use is expressly listed as a reportable situation.

The provision lists the absence of rotulación o instrucciones alongside defects, malfunctions and performance degradation. This means labelling compliance is not only a market-access question but also a continuing post-market obligation — the labelling requirements discussed in Article 29 of this series reappear here from the post-market angle. A batch shipped with an outdated or missing label is not merely a quality deviation to handle internally; it is a reportable situation in its own right, which raises the operational weight of label version control considerably.

Insight three: Article 28 is a regulation-level duty; the guide is operational.

Article 28 has been in force since 1999 and is a statutory obligation; the tecnovigilancia guide, including its current draft, is operational guidance. The two run in parallel: the regulation defines what must be reported; the guide defines how and within what time it must be reported. When the final guide is published, what changes is the second half, not the first. This layering is also the reason the guide cannot be read as narrowing Article 28 in any respect.

Insight four: manufacturers cannot refrain from reporting because the hospital will report.

The regulation imposes an independent obligation on importers and manufacturers — reporting the technical or medical reasons behind a systematic recall. Relying on healthcare institutions to report on the manufacturer’s behalf leaves the manufacturer-side duty unfulfilled, and the consequences fall on the licence holder and the manufacturer. In practice, the information that reaches a manufacturer through commercial channels is often late, incomplete, or filtered; the statutory duty assumes a reporting channel the manufacturer must build itself.

4. Practical recommendations

1. Build assessment checklists for the two trigger conditions: patient-harm situations (the healthcare-institution line) and systematic-recall causes (the importer/manufacturer line), so each incoming signal is routed to the correct obligation.
2. Bring labelling and instructions-for-use compliance into continuing post-market checks, treating any missing or outdated label as a reportable situation rather than an internal quality note.
3. Manufacturers should establish their own reporting channel proactively: they cannot depend on healthcare institutions reporting on their behalf.
4. State information return deadlines in distribution agreements, ensuring the Chilean side receives events early enough to report on time.
5. Keep the regulation duty and the guide’s operational requirements distinct: the regulation duty must be performed now, while guide deadlines are switched over when the final text takes effect.

5. Verification checklist

• □ Assessment checklists for the two trigger conditions have been established
• □ Labelling and instructions-for-use compliance is included in continuing post-market checks
• □ The manufacturer has established an independent reporting channel
• □ Distribution agreements state the deadline for returning information
• □ The duty under Article 28 of DS 825/1998 has been distinguished from the guide’s operational requirements

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.