Peru IVD Registration Pathway Explained: Dual-Track Rules and 2026 Clock

Regulatory information verified as of October 29, 2026

1. Key takeaways

In vitro diagnostic devices (Dispositivo Médico de Diagnóstico In Vitro, IVD) in Peru run through a channel that operates in parallel to the Class I–IV risk grading: the First Supplementary Transitory Provision of D.S. N° 001-2012-SA, published on 2012-01-22, points IVD to the D.S. N° 010-97-SA framework, published on 1997-12-23, and classification rests on the list compiled by R.M. N° 283-98-SA/DM, published on 1998-08-07, organized by function and professional use — not on the 18 classification rules of D.S. N° 003-2020-SA. The IVD review clock is 30 working days. As a consequence, the question of which Class an IVD belongs to is, in Peru, not a well-formed question: the IVD system classifies by function and specialty, and any attempted conversion into a Class I–IV level invents a rule that no regulation contains. Dossiers, schedules and fee rows must all be planned on the IVD track from the outset.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: the transitory provision is a jurisdiction switch — it creates a dual track, not a transition period.

The First Supplementary Transitory Provision of D.S. N° 001-2012-SA leaves IVD inside the D.S. N° 010-97-SA system, while all other devices follow D.S. N° 016-2011-SA and its amendments. The wording speaks of transition, but the practical effect has been a long-term dual track: IVD are still processed under the regulation published on 1997-12-23 and the list published on 1998-08-07. The mechanical consequence lands directly on corporate process — when the same company files an analyzer and its companion reagents, the two submissions differ in governing regulations, dossier structure and document lists, and forcing both through one template will produce errors in one of them. Internal quality systems should treat the IVD track and the device track as genuinely separate submission families.

Insight 2: the classification logics are of different origin, which is why level conversion is meaningless.

The Class I–IV system is a risk grading: the 18 classification rules in Anexo 1 of D.S. N° 003-2020-SA decide the level through risk dimensions such as invasiveness, contact duration and connection to an active system, outputting a level from I to IV. The classification of R.M. N° 283-98-SA/DM is organized by function and professional use — clinical chemistry, immunology, microbiology and other specialty domains — and outputs professional categories; indeed the category added by D.S. N° 020-2001-SA, published on 2001-07-16, uses the letter sequence Ñ rather than a Roman numeral. The two coding systems are not isomorphic, and any statement that a given IVD corresponds to Class III is a self-made rule that will not be accepted when cited.

Insight 3: the evidentiary center of gravity falls on analytical performance, not clinical risk.

Because the classification system differs, the technical center of gravity of the IVD dossier differs too. D.S. N° 020-2001-SA requires diagnostic reagents to state specificity and sensitivity on the label, and that requirement reveals the regulatory concern: the core risk of an IVD arises from clinical decision errors caused by wrong test results, so analytical performance — specificity, sensitivity, precision, detection limit, interference and cross-reaction — forms the body of evidence. Writing an IVD dossier on the device template of an essential-principles checklist plus clinical evaluation produces an evidence mismatch: stacks of clinical literature with no analytical performance validation data.

Insight 4: emergency-layer documents do not change the ordinary channel.

R.M. N° 435-2020/MINSA, published on 2020-06-27, on the control and vigilance of COVID-19 rapid and molecular tests, and R.M. N° 694-2020/MINSA, published on 2020-09-03, on the validation of IVD under investigation for COVID-19, are special-purpose documents adopted during the public health emergency for specific products. They govern control and validation requirements in their defined scenarios, do not replace the ordinary IVD registration channel, and cannot be extended by analogy to the documentation requirements of ordinary products.

4. Practical recommendations

1. Make the channel determination before filing: confirm whether the product falls within the IVD definition; if it does, follow the D.S. N° 010-97-SA plus R.M. N° 283-98-SA/DM channel and do not apply the 18 classification rules of D.S. N° 003-2020-SA.
2. Locate by functional domain, not risk level: find the corresponding entry in the R.M. N° 283-98-SA/DM list by detection principle and professional use, checking the current text as amended by R.D. N° 1137-2003-DG-DIGEMID (2003-09-01) and R.D. N° 1305-2005-DG-DIGEMID (2005-09-16).
3. Build the dossier around analytical performance: organize validation reports around specificity and sensitivity, and state both indicators on the label as required by D.S. N° 020-2001-SA.
4. Schedule by channel: the IVD clock is 30 working days, separate from the 22 / 44 / 66 working days of non-IVD devices; keep the two baselines apart to avoid applying the wrong one.
5. Split combination-product submissions: file instruments and reagents each through their own channel and cross-reference the other’s registration number in the dossier; never cover both with one mixed file.
6. Use emergency documents as reference only: R.M. N° 435-2020/MINSA and R.M. N° 694-2020/MINSA are not sources for ordinary product documentation.

5. Verification checklist

□ It has been confirmed that the product is an IVD following the D.S. N° 010-97-SA channel indicated by the First Supplementary Transitory Provision of D.S. N° 001-2012-SA

□ It has been confirmed that classification rests on R.M. N° 283-98-SA/DM (1998-08-07) and its two amendments, with no application of the I–IV levels

□ The current texts of R.D. N° 1137-2003-DG-DIGEMID (2003-09-01) and R.D. N° 1305-2005-DG-DIGEMID (2005-09-16) have been checked

□ The product has been located in the list by function and professional use, with no level conversion attempted

□ Analytical performance data on specificity and sensitivity have been prepared and the corresponding indicators stated on the label (D.S. N° 020-2001-SA)

□ Scheduling follows the 30 working days clock, managed separately from the non-IVD channel

□ It has been confirmed that emergency-period special documents do not apply to ordinary submissions

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides registration support in Peru for manufacturers, importers and authorized representatives, including IVD pathway determination and analytical performance dossiers. Contact: info@grzanglobal.com