Chile FSCA and Recall Obligations under the National Tecnovigilancia Guide

1. Key takeaways

The ISP consultation draft of the National Tecnovigilancia System Guide sets a dual-track obligation for field safety corrective actions (FSCA) and recalls: report to the ISP using form ANDIM/012, and simultaneously inform customers through a field safety notice in Spanish. The deadlines: generally 10 working days; for recalls, and for actions involving death or permanent harm with a high probability of occurrence, 3 working days.

This set of deadlines remains a proposed requirement as of October 29, 2026 — the guide is a consultation draft, pending verification of the final text. GRZAN recommends building capability against the proposed requirements while continuing to perform current duties under the existing system. The dual-track structure deserves particular attention in advance planning: the two tracks — reporting to the authority and informing the market — are independent duties that must be executed in parallel, each with its own owner, its own template and its own deadline, and neither can wait for the other. Companies that sequence them discover too late that drafting a Spanish notice from scratch consumes exactly the days the deadline does not have.

2. Legal basis

• ISP public consultation | National Tecnovigilancia System Guide | launched August 27, 2026, consultation period until September 27, 2026 | FSCA and recalls: notify the ISP using form ANDIM/012 and simultaneously inform customers through a field safety notice in Spanish; general reporting period 10 working days; 3 working days for recalls and for specific actions related to death or permanent harm with a high probability of occurrence.
• Same source | record keeping | keep receipts, investigation records, risk assessments, distribution records, and reconciliation records of the number of units recalled; the ISP may require annual reports for specific devices or IVDs.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 28: 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.
• Current system | Norma General Técnica N° 204 | published January 16, 2019 | the current basis of tecnovigilancia duties.

3. Expert insights

Insight one: the dual-track obligation means reporting to the ISP and notifying customers are two separate things, and neither substitutes for the other.

The guide requires simultaneously (simultáneamente) reporting to the ISP and issuing the Spanish-language notice to customers. Doing only one of the two leaves the other unfulfilled. GRZAN builds both actions into recall plans as parallel workstreams, each with a designated owner, so that neither track stalls behind the other. In practice the customer-notification track is the one that fails more often, because it depends on templates, translations and contact lists that must exist before the event — none of which can be improvised inside a 3-working-day window.

Insight two: the 3-working-day tier covers two situations.

Recalls (retiro del mercado) and specific actions involving death or permanent harm with a high probability of occurrence fall under 3 working days. That tier sits only one working day above the strictest adverse-event deadline (sentinel events at 2 working days), meaning a recall demands a response on essentially the same time scale as the most serious safety event. Planning assumptions built around weeks rather than days will fail this tier, which is why the decision authority for launching a recall must be pre-authorised rather than assembled ad hoc.

Insight three: the Spanish-language notice is an independent formal requirement.

The field safety notice must be in Spanish. This is not a translation add-on but a compliance element in its own right — a notice issued in English does not satisfy the requirement. Preparing the Spanish template in advance, with product identification, risk description, the action users must take, and contact details already laid out, converts a legal risk into a fill-in exercise during the crisis.

Insight four: record keeping is the evidence that closes the recall loop.

The guide requires keeping receipts, investigation records, risk assessments, distribution records, and reconciliation (conciliación) records of the number of units recalled. The reconciliation is the item most often overlooked — it demonstrates the coverage rate of the recall and is also key evidence in defending against civil liability claims. A recall without a documented unit-by-unit reconciliation is, from an evidence standpoint, an unfinished recall.

4. Practical recommendations

1. Set reporting to the ISP and the Spanish customer notice as parallel dual tracks in the recall plan, each with its own owner and deadline, so neither action waits on the other’s completion.
2. Prepare Spanish field safety notice templates in advance, covering product identification, risk description, the action users must take, and contact details, so the notice can be issued within the shortest tier.
3. Establish a recall reconciliation mechanism: quantities issued, quantities recovered, and quantities outstanding reconciled line by line and archived as the recall progresses.
4. Keep the five categories of records: receipts, investigation records, risk assessments, distribution records, and reconciliation records, organised so they can be produced as a coherent set on ISP request.
5. Pre-authorise the decision path for the 3-working-day tier, avoiding multi-level approval chains that consume the deadline before the action even starts.

5. Verification checklist

• □ Confirmed that FSCA and recall deadlines are proposed requirements
• □ The recall plan sets the dual track of reporting to the ISP plus the Spanish customer notice
• □ Spanish field safety notice templates are pre-positioned
• □ A recall quantity reconciliation mechanism exists
• □ The five-category record-keeping list is implemented

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.