Principios Esenciales Checklist for Class II-III-IV Devices in Peru

Regulatory information verified as of October 29, 2026.

1. Key takeaways

The Essential Principles (Principios Esenciales de Seguridad y Desempeño) checklist is the page most frequently rejected in Class II-IV technical files, because it is not a declaration of promised compliance but an index table that points item by item to the location of evidence. D.S. N° 003-2020-SA, published on 2020-02-06, established the checklist; before that, D.S. N° 016-2017-SA had already replaced condiciones esenciales with principios esenciales throughout Title IV on 2017-06-07. Any dossier that reuses a pre-2020 template will be rejected under the new framework for both terminology and format non-conformity, and the correction runs against a review clock that does not stop. For Classes II-IV the checklist is a mandatory dossier component, so its quality directly determines whether the technical file passes review on first submission or enters the correction cycle.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The checklist functions as an evidence index, not a declaration of conformity.

The essential principles entries cover the general safety and performance requirements for devices, and the reviewer checks them one by one, with every check depending on a specific evidence file and page. A checklist without cross-references is equivalent to a non-submission in the reviewer’s view, because it does not allow the review to be completed without reading the entire dossier. This is the first-ranked reason the page is rejected: writing the checklist as a single sentence asserting that the product complies with all essential principles. A usable index gives, for every principle, the exact document, version and location of the supporting evidence. Where a principle is not applicable, the entry should say so expressly with the reason, because silent gaps are read by the reviewer as missing evidence rather than as considered exclusions.

Insight 2: Evidence sources have an order of acceptance, and citations must carry version and coverage.

The evidence supporting each principle typically comes from the ISO 14971 risk management report, ISO 10993 biological evaluation, IEC 60601 series electrical safety and electromagnetic compatibility reports, sterilization validation reports, shelf life and transport validation reports, and, for Classes III and IV, the clinical evaluation report. When citing harmonized standards, the standard number must carry its version, the covered clauses must be stated, and deviations must be listed. A citation without a version leaves the reviewer unable to judge the temporal validity of the evidence; a version without covered clauses leaves the reviewer unable to confirm whether the principle is fully covered. As a working rule, each cited standard should be accompanied by a short coverage statement naming the clauses that satisfy the principle and any clauses for which an alternative method was used, so that the reviewer can complete the cross-check without requesting additional documents.

Insight 3: Terminology unification was planted in 2017 and its cost matured in 2020.

D.S. N° 016-2017-SA, published on 2017-06-07, changed the Title IV terminology to principios esenciales, and only three years later did D.S. N° 003-2020-SA land the checklist itself. This rhythm of terminology first and checklist later means that dossier templates written before 2020 no longer match the current framework in either terminology or conformity format. A company that reuses an old technical file triggers a format rejection and a content correction at the same time, while the review clock keeps running on the 22 / 44 / 66 working days track, and correction time is not deducted from it. For manufacturers filing in multiple jurisdictions in parallel there is a further consequence: if one technical file must serve Peru and other markets at once, the essential principles conformity should be isolated as a separate chapter in the source document, with the checklist page generated per jurisdiction, rather than shared as one generic declaration page.

4. Practical recommendations

1. Adopt a three-column format: principle entry, evidence file name and version, and page or chapter number inside the file; fill every row and leave no blanks.
2. Cite standards with full versions: state the standard number, version and covered clauses, list deviations separately and explain them.
3. Bind the checklist to the classification: Classes II-IV must attach it; Class I follows the dossier requirements of Art. 124 and does not copy the Class II format.
4. Rewrite legacy dossiers on the new framework: rework terminology and conformity format for all pre-2020 templates rather than patching them locally.
5. Reserve a correction buffer: correction of observations (Observaciones) must be completed within 30 working days (practical estimate), so do not schedule against a fully loaded review clock.
6. Update the checklist with product changes: once design, materials or the sterilization method change, recheck the affected principle entries and update evidence page references so the checklist never drifts from the technical file.

5. Verification checklist

□ Confirmed that Class II-IV dossiers attach the essential principles conformity checklist

□ Confirmed that the checklist uses a three-column index format with a document and page for each entry

□ Confirmed that cited harmonized standards carry version numbers and covered clauses

□ Confirmed that the terminology is unified to principios esenciales and the legacy wording is not used

□ Confirmed that pre-2020 templates were not reused directly

□ Confirmed that the correction buffer is reserved on the 30-working-day basis (practical estimate)

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides medical device registration support in Peru for manufacturers, importers and authorized representatives. For inquiries, contact info@grzanglobal.com.