D.S. 003-2020-SA Classification Rules: Peru and the IMDRF 18 Rules

Regulatory information verified as of October 29, 2026.

1. Key takeaways

D.S. N° 003-2020-SA, published on 2020-02-06, replaced experience-based classification with the 18 classification rules of Anexo 1, arranged in 4 groups covering non-invasive, invasive, active and additional rules; the technical line is derived from the same source as the IMDRF framework and the EU MDR. The practical conclusion of that common origin is that classification conclusions from other jurisdictions may be cited as argumentation material but cannot be transplanted directly. Once a class is fixed, it simultaneously locks the dossier depth (Art. 124 for Class I, Art. 125 for Class II) and the review clock (22 / 44 / 66 working days), and the final determination authority rests with DIGEMID. In planning terms this means the classification exercise is not a paperwork step at the edge of the project: it is the variable that drives evidence budgets, clinical evaluation needs, timelines and the applicable conformity documents, so it should be completed and documented before any dossier writing begins.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The 18 rules form a decision sequence, not a menu from which to pick.

The rules of Anexo 1 are organized by the way the device contacts the human body, its duration of use and its source of energy, and they must be applied in order, rule by rule, stopping at the first hit. This explains why the same product can receive different classes in the hands of different companies: the common error is jumping ahead, applying the rule that seems to fit while skipping the preceding rules, and thereby underestimating the risk class. GRZAN requires a rule-by-rule comparison record in its grading work, documenting the exclusion reasons for every rule found inapplicable, precisely to close this loophole.

Insight 2: The additional rules are a lateral upgrade mechanism that often pushes Class II to Class III.

The additional rules address cross-cutting attributes: the presence of medicinal substances, animal or human derived materials, or a killing or inactivating function. Their mechanism is additive: the first three groups of rules produce a base class, and the additional rules then determine whether the class rises. In practice this group is the most underestimated. Companies grade by the physical form of the device and ignore upgrade clauses triggered by formulation or material properties; the dossier is prepared for Class II, the review demands Class III evidence, and the filing is rejected outright. The rework is not limited to rewriting one form: the entire evidence plan, including the essential principles checklist and the review-clock assumption, must be rebuilt, which is why the additional-rule check belongs at the very start of grading rather than at the end.

Insight 3: Common origin does not mean equivalence, and the class binds downstream costs.

A common technical lineage means the reasoning can be cross-referenced: a classification analysis completed under the IMDRF or EU MDR rules has reference value in its analytical framework. But the Peruvian class is the product of a local administrative determination, and once fixed it binds three things at once: dossier composition (Art. 124 and Art. 125 as the documentary bases for Class I and Class II), the review clock (22 / 44 / 66 working days), and the applicability of the essential principles checklist (Classes II-IV). The correct order is therefore to self-assess and keep records, then cross-validate against external opinions, and finally accept the DIGEMID determination, rather than copying the class printed on a foreign certificate into the application form.

4. Practical recommendations

1. Produce a rule-by-rule application record: compare each of the non-invasive, invasive, active and additional rules in the 4-group order, stating the reasons for applicability and non-applicability.
2. Run a dedicated additional-rule check: for each SKU, verify separately whether it contains medicinal substances, animal or human derived materials, or a killing or inactivating function, and judge whether an upgrade is triggered.
3. Link class, dossier and clock: once the grading conclusion is issued, confirm in the same step the dossier composition, the review clock, and whether the essential principles checklist is required.
4. Use foreign classifications as arguments, not conclusions: when citing the IMDRF or EU MDR analytical framework, mark it explicitly as argumentation material; the class on the application is subject to the DIGEMID determination.
5. Bind grading to use claims: whenever a use claim changes, run the 18 rules again instead of reusing the old conclusion.

5. Verification checklist

□ Completed a documented rule-by-rule comparison under the 18 rules of Anexo 1

□ Completed a dedicated check of additional-rule triggers (medicinal substances, animal or human derived materials, killing or inactivating functions)

□ Confirmed the dossier articles corresponding to the class (Class I Art. 124, Class II Art. 125)

□ Confirmed the review clock corresponding to the class (22 / 44 / 66 working days)

□ Confirmed that Classes II-IV must attach the essential principles checklist

□ Confirmed that the class on the application follows the DIGEMID determination, with foreign conclusions used only as argumentation

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.