Peru Medical Device Definition and Scope: Software and Accessories

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Peru does not maintain a dedicated chapter for software as a medical device. Whether software falls within the device definition depends on whether it appears together with a device use claim within the meaning of Ley N° 29459, published on 2009-11-26; accessories are classified with their parent device, and combination products are determined by their principal mode of action. The operative point is not the definitional article but the 18 classification rules in Anexo 1 of D.S. N° 003-2020-SA, published on 2020-02-06. The definition answers only the question of whether a product is a device; the classification rules answer which class it belongs to and which dossier must be submitted. Merging these two questions is the primary reason software and accessory products are rejected in Peru. In planning terms, the sequence should be fixed in the project schedule: definition first, classification second, dossier structure third, so that every document written downstream inherits a settled class and scope instead of forcing rework when DIGEMID reads the file in its own order.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: Definition and classification operate in sequence, and a break between them creates an unowned product.

At the definition level, the only question is whether the product is a device. Once the answer is yes, the product passes immediately to the 18 classification rules for grading. The common practical error looks like this: software is filed on its own, the hardware is described separately as an accessory, and the result is that the software obtains a sanitary registration while the hardware accessory has no independent registration record, so customs clearance stalls because a matching number is missing. The mechanically correct approach is to submit accessories as components of the parent device dossier, or to plan separately verifiable numbers for the parent device and each accessory; the two options cannot substitute for each other.

Insight 2: The key to combination products is the principal mode of action.

If a drug-device combination acts mainly through pharmacological, immunological or metabolic means, it does not follow the device path; only when the principal action derives from physical means does it enter the device scope and pass to the classification rules for grading. This determination must be stated on the first page of the dossier, with its basis and conclusion, because when the explanation is missing the reviewer will demand data under the strictest path, and a Class I product may be asked to prepare the evidence chain of a Class III or IV device. The written judgment is not formalism; it is the only tool that limits the scope of review.

Insight 3: The border between software and in vitro diagnostic devices is where the wrong channel is most often chosen.

In vitro diagnostic devices in Peru do not enter the Class I-IV scale: R.M. N° 283-98-SA/DM, published on 1998-08-07, classifies them by function and specialty, and the first supplementary transitional provision of D.S. N° 001-2012-SA further points IVDs to D.S. N° 010-97-SA, published on 1997-12-23. Accordingly, an algorithm module used for in vitro diagnostic image analysis or result interpretation should be handled through the IVD channel, not filed under the Class I-IV path for medical software; likewise, the specificity and sensitivity labeling required by D.S. N° 020-2001-SA, published on 2001-07-16, is an obligation specific to that channel.

4. Practical recommendations

1. Issue a written determination memo: for each SKU, produce one page stating whether the product is a device, the basis for the judgment, the applicable classification rule numbers and the resulting class, and submit it with the dossier.
2. File accessories with the parent device: place the accessory list, compatibility statements and the parent device use claims in the same technical file, so that no registration number is left missing.
3. Run the principal-mode-of-action determination first for combination products: record the conclusion and basis on the first page, and keep a pharmacological-path fallback plan ready.
4. Ask first whether an algorithmic product is an in vitro diagnostic device: if yes, follow the D.S. N° 010-97-SA channel and satisfy the specificity and sensitivity labeling duties.
5. Keep use claims consistent with the classification conclusion: use statements in instructions for use, labels and promotional materials must not exceed the use scope on which the classification determination was based.

5. Verification checklist

□ Completed a written is-it-a-device determination with basis for each SKU

□ Completed grading under the 18 rules of Anexo 1 of D.S. N° 003-2020-SA

□ Confirmed that accessories are filed with the parent device and carry verifiable numbers

□ Confirmed that the principal-mode-of-action conclusion for combination products appears on the first page of the dossier

□ Confirmed that algorithmic modules are handled through the in vitro diagnostic device channel (D.S. N° 010-97-SA)

□ Confirmed that label and instructions-for-use claims do not exceed the scope of the classification basis

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.