Peru IVD Technical Specification: The Six Required Items Under D.S. N° 010-97-SA

Regulatory information verified as of October 29, 2026

1. Key takeaways

In vitro diagnostic devices, the Dispositivo Médico de Diagnóstico In Vitro or IVD, do not follow the Class I to IV risk classification pathway in Peru. Their registration dossier consists of 6 items: the application, the Certificate of Free Sale, the Certificado de Libre Venta or CFS, the quality evidence, the technical specification, the proposed label, and the instructions for use in Spanish, the Instrucciones de Uso or IFU. The essential difference sits in item 4: an IVD submits a technical specification centered on analytical performance parameters, whereas a Class I to IV device submits a technical report centered on product description and the justification of safety and performance. The two documents are written on different logic, and copying from one template to the other produces a file that fails on both sides at once.

2. Legal basis

Restrictive note on coverage: analyzers, software, calibrators, diluents, buffers, and quality control materials are not covered by the IVD registration item, based on the listing scope of R.M. N° 283-98-SA/DM, with item numbers subject to the official publication.

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: Two regulations create two documentation logics, and a single universal template necessarily fails here.

IVDs are directed, through the first supplementary transitional provision of D.S. N° 001-2012-SA, published on 2012-01-22, to D.S. N° 010-97-SA, published on 1997-12-23. They therefore fall outside the 18 classification rules system of D.S. N° 003-2020-SA, and they carry neither the progressive structure of an Essential Principles list plus a risk management report that Class II requires, nor the item 9 sterilization validation and item 10 clinical evaluation report of Class III/IV. The mechanical consequence is symmetrical: filling an IVD dossier with Class I to IV template content produces sections with no corresponding provision that must be deleted on request, while the IVD items removed to make room cannot be restored under the IVD system either.

Insight 2: The review object of item 4, the technical specification, is whether the parameters are decidable, not whether the description is detailed.

The technical specification answers whether the reagent can be measured and whether the measurement is accurate: decidable, quantified indicators such as analytical sensitivity and specificity, detection limit, precision, linearity or measuring interval, interference, and cross-reactivity, together with the associated sample types and interpretation rules. D.S. N° 020-2001-SA, published on 2001-07-16, requires diagnostic reagents to state specificity and sensitivity on the label, which extends this same logic to the labeling end: the performance parameters written in item 4 must also land on the item 5 label. By contrast, the Class I to IV technical report answers what the device does to the human body and how its risks are controlled. The two documents do not address the same question and cannot substitute for each other.

Insight 3: The boundary of the coverage list makes a coverage determination the first step of every IVD project.

Analyzers, software, calibrators, diluents, buffers, and quality control materials are not covered by the IVD registration item, based on the listing scope of R.M. N° 283-98-SA/DM, with item numbers subject to the official publication. This boundary means that instruments and reagents appearing in the same tender list may fall into different handling pathways: the reagent enters the IVD channel, while the instrument or companion software requires a separate determination of its device status and corresponding channel. For projects that bring an instrument to market with its reagents, GRZAN treats the coverage determination as step one and derives the channel and document list from it.

4. Practical recommendations

1. Run the coverage determination at project start, comparing each product against the listing scope of R.M. N° 283-98-SA/DM and its amendments, R.D. N° 1137-2003-DG-DIGEMID and R.D. N° 1305-2005-DG-DIGEMID.
2. Write item 4 in a parameter-based format: every performance indicator carries a numerical value and a methodological basis, with no qualitative descriptions.
3. State specificity and sensitivity on the label as required by D.S. N° 020-2001-SA, keeping the values identical to the technical specification.
4. Evaluate the pathway for analyzers and companion software separately, and do not bundle them into the reagent submission.
5. Ensure the item 2 CFS and the item 3 quality evidence cover all declared specifications.
6. Schedule the IVD review clock as 30 working days, a practical estimate, with specific article numbers pending verification, subject to the official publication.

5. Verification checklist

□ Coverage within the IVD scope is confirmed, with no analyzers, software, calibrators, diluents, buffers, or quality control materials mistakenly included

□ All 6 items are complete under the D.S. N° 010-97-SA pathway

□ Item 4 is a technical specification containing decidable parameters such as analytical sensitivity, specificity, detection limit, and precision

□ Item 5, the proposed label, states specificity and sensitivity as required by D.S. N° 020-2001-SA

□ Item 6, the IFU, is in Spanish and uses terminology consistent with the label

□ The schedule follows the 30 working days review clock, and the IVD classification category has been confirmed

Regulatory information verified as of October 29, 2026.

*GRZAN Regulatory Team*

GRZAN provides IVD registration support in Peru for manufacturers, importers, and authorized representatives, covering coverage determination, technical specification review, labeling, and deficiency response. For inquiries, contact info@grzanglobal.com.