Risk Management Report: Plan and Report under ANDID Instructivo 001

1. Key takeaways

Chilean submissions for Class III and Class IV devices must include a risk management plan and report, under ISP technical guidance ANDID instructivo 001, section 6.6. This is not optional, and it is not a document that can be replaced by holding an ISO 14971 certificate — a certificate proves the system exists; the plan and report prove that this specific product’s risks were actually managed through a documented process with criteria, responsibilities and conclusions.

GRZAN splits the obligation into one plan plus one report: the plan answers how the risks will be managed, and the report answers what the management produced. The two documents are reviewed against each other, so they must be consistent at every point where they overlap. This division also mirrors how ISO 14971 separates planning from the risk management file, so no extra work is needed to satisfy the standard while meeting the guidance.

2. Legal basis

• ISP technical guidance | ANDID instructivo 001, section 6.6 | Class III and Class IV device submissions must include a risk management plan and report (plan de gestión de riesgos e informe).
• Decree listing devices under the sanitary control regime of Article 111 | Decreto Exento N° 25, de 2026 | March 19, 2026 | conformity evaluation is benchmarked against NCh-ISO 14971 (risk management) and product-specific standards.
• Regulation on the control of pharmaceutical products and medical devices | Decreto Supremo N° 825, de 1998 | August 21, 1999 | Article 21: Class IV additionally requires studies of all inherent risks of the device; Class III requires the manufacturer’s effectiveness and safety studies.
• Sanitary Code | DFL N° 725, de 1967 | Article 111(c) | the standards hierarchy with Chilean official standards first.

3. Expert insights

Insight one: the Class IV study of all inherent risks is the highest evidentiary demand in Article 21.

The statutory wording is el estudio de todos los riesgos inherentes — a study of all the inherent risks of the device. This is broader than a risk management report: it demands a study (estudio), not a mere filing record. In Class IV projects GRZAN breaks it into four parts: an inventory of known risks, a risk evaluation matrix, a justification of the acceptability of residual risks, and a post-market surveillance plan. Presented this way, the submission demonstrates analysis rather than documentation, which is exactly what the word estudio implies. Framing the study as a research deliverable rather than an annex also changes who writes it: engineers and clinicians contribute content, not just a document controller assembling records.

Insight two: plan and report must correspond, but they must not repeat each other.

The plan is the methodological document: scope of the risk management activities, responsibilities, acceptability criteria and the triggers for review. The report is the conclusions document: for each risk, its identification, evaluation, control measures, residual risk evaluation and acceptability conclusion. Reviewers cross-check the two documents for consistency — the criteria stated in the plan must genuinely be the criteria applied in the report. Any divergence between declared method and applied method is treated as a defect in both documents at once. Where the acceptability criteria change between plan and report, the change must be justified and versioned, never silently updated.

Insight three: Spanish wording should follow Chilean regulatory terminology, not literal translation.

Risk management has fixed Spanish terms (riesgo, peligro, situación peligrosa, daño), and these carry precise meanings in the regulatory context. GRZAN recommends using the terminology of Chilean regulation rather than translating literally from another language, because a reviewer who meets unfamiliar phrasing must first decode it before evaluating it — and decoding time in a queue-driven review is paid for by the sponsor, usually in the form of clarification requests. A short glossary at the front of the plan, mapping each term to its use in the file, is enough to keep the terminology stable across documents and translators.

Insight four: risk management must close the loop with labeling and the instructions for use.

Where a risk control measure takes the form of a warning or a contraindication, the corresponding wording must appear in the Spanish label and instructions for use, and it must be worded consistently. A control measure listed in the risk report with no trace on the label is the single most easily queried break in the chain. The fix is administrative: maintain a mapping table from each risk control to its location in the label and IFU, and check it before every submission. GRZAN runs this check before every filing as a matter of routine, because it is faster to fix wording internally than to answer a formal query.

4. Practical recommendations

1. Organize the file as two documents, plan plus report: the plan covers method, the report covers conclusions, and they are not merged.
2. Expand the Class IV inherent risk study in four parts: known risk inventory, evaluation matrix, residual risk justification, post-market surveillance plan.
3. Use Chilean Spanish regulatory terminology and avoid literal translation from other languages.
4. Build a mapping table between risk measures and the label and IFU, confirming item by item that every warning and contraindication has landed in the Spanish texts.
5. Cross-index the risk management file with the ISO 13485 procedure documents, demonstrating that the measures are executed inside the quality system.

5. Verification checklist

• □ The risk management plan and report are prepared as two documents under ANDID instructivo 001 section 6.6
• □ The acceptability criteria in the report match those in the plan
• □ The Class IV inherent risk study is expanded in four parts
• □ The Spanish terminology follows Chilean regulatory usage
• □ The risk controls have been checked item by item against their counterparts in the label and IFU

Regulatory information verified as of October 29, 2026.

For a product-specific feasibility assessment of Chile market entry, GRZAN’s regulatory team supports manufacturers and importers with registration dossiers, conformity documentation and ISP submissions. Contact info@grzanglobal.com to discuss your project.