Peru Medical Device Regulation 2026–2027: Outlook and Action Plan

Regulatory information verified as of October 29, 2026

1. Key takeaways

The biggest change for Peru in 2026 is a restructuring at the procedural level: the Nuevo Texto Único de Procedimientos Administrativos del MINSA, the new consolidated administrative procedures text (TUPA), was published by D.S. N° 011-2026-SA on 2026-07-21, repealing the former D.S. N° 001-2016-SA and its subsequent amendments; in the same period DIGEMID issued several communications, and the new medical device regulation R.M. N° 734-2024/MINSA remains in public consultation, with its final reference number and effective date still undetermined. The direct impact on companies: the single authoritative source for fees, deadlines and requirements has switched to the new TUPA, and any schedule still built on the old manual must be recalculated. Regulatory information verified as of October 29, 2026.

2. Legal basis

3. Expert insights

Insight 1 | The value of the new TUPA lies in its single-source character; the risk lies in residual old documents

D.S. N° 011-2026-SA (2026-07-21) consolidates scattered procedures, requirements, deadlines and fees into one text and expressly repeals the old TUPA and its subsequent amendments. This yields one operational judgment: any quotation, payment slip or schedule still based on D.S. N° 001-2016-SA after July 21, 2026 should be voided and rebuilt. The first step we take at project launch is to align the client’s procedure lists line by line against the new TUPA, with particular attention to payment nodes — rejection for an incorrect amount typically arrives earlier than rejection for a technical deficiency, and is more easily overlooked.

Insight 2 | The signal of the three Comunicados: requirements are converging on presence of people, substance of reports, and validity of certificates

The Comunicados recorded in secondary sources — N° 009-2026 (2026-07-05, clinical evaluation reports), N° 011-2026 (2026-08-19, registration and re-registration requirements) and N° 012-2026 (2026-08-25, pharmaceutical establishment availability and presence of the technical director) — point respectively at technical evidence, application requirements and entity operation. Read together, the logic is consistent: the competent authority is tightening verifiability at both ends, the entity and the evidence — first, the technical director (Director Técnico) must be present and performing; second, the establishment must remain available; third, the clinical evidence must be documented and retrievable. Since all three are secondary-source records, the specific provisions are subject to the official publication of DIGEMID, and we make no external commitments to any new mandatory step on that basis.

Insight 3 | New device regulation and the IVD chapter: keep expectations, drop the schedule

R.M. N° 734-2024/MINSA, as the new Peruvian medical device regulation, remains in public consultation; its final reference number, publication date and effective date are all undetermined. Our judgment is that the technical route will continue aligning with the IMDRF and the EU MDR, but until official publication there is no transition period — absent a formal reference number and effective date, any statement about the length of a transition period is speculation. For IVDs (Dispositivo Médico de Diagnóstico In Vitro), the current channel still runs, through the first transitional provision of D.S. N° 001-2012-SA (2012-01-22), toward D.S. N° 010-97-SA (1997-12-23); whether the new regulation will give IVDs their own chapter likewise awaits the final official publication. It should also be noted that D.S. N° 014-2026-SA (2026-09-09) provides for a 90-calendar-day institutional restructuring of MINSA, recorded in secondary sources; this article treats it as background only, without deriving any specific registration duty from it.

4. Practical recommendations

1. Stop using old-TUPA procedure lists and fee tables immediately, and rebuild internal templates line by line under D.S. N° 011-2026-SA (2026-07-21).
2. Run a procedural cross-check on all pending applications: whether requirements, deadlines, fees and forms still carry traces of the old text.
3. Treat Comunicados N° 009, 011 and 012 as watch items in internal briefings; before actual execution, the official publication of DIGEMID prevails.
4. Verify entity-operation items: presence of the technical director and availability of the pharmaceutical establishment (Establecimiento Farmacéutico), with early self-inspection and gap filling.
5. Maintain contingency-style tracking of R.M. N° 734-2024/MINSA: prepare two dossier skeletons (the current basis and a possible deeper IMDRF-aligned basis), without committing externally to any effective date.
6. Recalculate financial risk exposure and penalty expectations at the 2026 UIT of S/ 5,500 (up from S/ 5,350 in 2025).

5. Verification checklist

□ The new TUPA basis of D.S. N° 011-2026-SA (2026-07-21) has been confirmed, together with the repeal of D.S. N° 001-2016-SA and its subsequent amendments (regulatory information verified as of October 29, 2026).

□ All pending applications have completed the procedural cross-check across requirements, deadlines, fees and forms.

□ The three Comunicados (2026-07-05, 2026-08-19, 2026-08-25) have been marked as secondary-source records, with the official publication prevailing.

□ The status of R.M. N° 734-2024/MINSA has been marked as in public consultation, with the final reference number and effective date subject to the official publication, and no effective date has been invented.

□ D.S. N° 014-2026-SA (2026-09-09, 90-calendar-day institutional restructuring) is treated as background only, without deriving specific registration duties.

□ The current IVD channel under D.S. N° 001-2012-SA (2012-01-22) and D.S. N° 010-97-SA (1997-12-23) has been verified.

□ The 2026 UIT of S/ 5,500 (up from S/ 5,350 in 2025) has been applied to the fine risk calculation.

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration and post-market compliance support in Peru for manufacturers, importers and authorized representatives. For assistance, contact info@grzanglobal.com.