CAUCE · A GUIDE TO PERU’S HEALTH AI RULES

Health AI in Peru.
Know what to check.

Planning a digital health or AI project in Peru? CAUCE helps you identify the regulatory, safety and evaluation questions to resolve before you move ahead.

The regulatory framework has only been partially verified. Check current official sources and the requirements that apply to your project before making decisions.

Up to 6 questions. Not sure about something? You can say so.

Medical device registration

Questions for DIGEMID, Peru’s medicines and medical devices regulator.

Clinical risk

What could go wrong, and how it could affect care.

Evaluation and pilot studies

The evidence and approvals to consider before testing.

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CAUCE · YOUR INITIAL REVIEW

Your next steps,
in three areas.

Review each area separately. A decision about registration does not settle questions about clinical risk or evaluation requirements.

This guide is for educational use. It does not establish that a product is “approved”, “safe” or “exempt”. Before marketing it, starting research or using it in patient care, confirm the requirements with the relevant authorities and institution.

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Sources, limitations and other requirements

Partial verification. The following were checked against El Peruano, Peru’s official gazette, on 19 October 2026: R.M. 164-2025/MINSA, NTS 235 (R.M. 664-2025/MINSA), D.S. 115-2025-PCM, D.S. 020-2025-SA and R.M. 903-2026/MINSA. Pending verification: R.M. 188-2026-MINSA, D.S. 005-2021-SA, Ley 29733, D.S. 016-2024-JUS, D.S. 016-2011-SA, Ley 29459, D.S. 003-2020-SA, R.M. 233-2020-MINSA and D.S. 021-2017-SA. Check for changes before acting.

Other requirements to check

Depending on your product and how it will be used, these requirements may also apply.

Health data and privacy

If your project collects, accesses, stores or shares data that identify someone or could be linked back to them, check the purpose and the applicable legal basis or consent. Review who is responsible, which service providers are involved, where data are transferred, security safeguards and individual rights. Permission to use data for clinical care does not automatically cover training an AI model. Personal Data Protection Law · Ley 29733 → · Implementing regulations · D.S. 016-2024-JUS →

Telehealth and health records

For remote care, review how the service is organized, the health professional and healthcare provider institution (IPRESS), consent, recordkeeping and confidentiality. Health records and the National Electronic Health Records Registry (RENHICE) have specific rules on access and audit trails. If your electronic health record system (SIHCE) requires accreditation, review Administrative Directive (Directiva Administrativa) N° 373-MINSA/OGTI-2025 and the regulation extending its deadlines: R.M. 164-2025/MINSA → · R.M. 188-2026-MINSA [pending verification] →. Telehealth regulations · D.S. 005-2021-SA → · Telehealth technical standard · NTS N° 235-MINSA/DIGTEL/2025, R.M. 664-2025/MINSA → · RENHICE regulations · D.S. 020-2025-SA →
Effective dates: access to de-identified RENHICE data for academic research is subject to conditions, a ban on commercial use and a 12-month transition from 28 November 2025. This guide does not confirm that access is available.

AI governance: who the rules apply to

For AI systems, check whether the use is high-risk or prohibited, and review the oversight and transparency requirements. Obligations and deadlines depend on who is developing or using the system. For high-risk AI systems, the impact assessment under art. 32 is voluntary in the private sector; art. 30 establishes an obligation for the public sector. D.S. 115-2025-PCM →
The AI policy published on 6 October 2026 applies within Peru’s Ministry of Health (MINSA). It should not be treated as a policy that applies to every private healthcare provider. R.M. 903-2026/MINSA →

Evidence before and after a pilot

CAUCE recommends documenting the relationship between the output and the clinical condition, technical verification and validation in the intended population. Define what you will compare the product against, the outcomes you will measure, potential bias, relevant subgroups, usability and contingency plans. The evidence needed depends on the intended use, risk and gaps in existing evidence. Not every product needs a new prospective trial. Clinical evaluation guidance · IMDRF N41 → · World Health Organization (WHO), 2023 →

Existing registrations, updates and ongoing monitoring

If the product is already registered, check who holds the registration and which product, configuration and intended use it covers. Do not assume it covers a new version or a change in purpose. Once use in patient care is authorized, plan how to monitor performance, handle incidents, detect deterioration and withdraw the product if needed. Search DIGEMID registrations → · D.S. 016-2011-SA, as amended → · Medical device safety monitoring →
For research: Ethics committees → · Clinical trial procedures · INS / Peruvian Clinical Trials Registry (REPEC) →

Sources and how to read them

Peruvian laws and regulations are distinguished from international guidance. In legal citations, Ley means Law, D.S. means Supreme Decree, R.M. means Ministerial Resolution and NTS means Technical Health Standard. Recommendations from CAUCE are labeled as editorial guidance.

REVIEW STATUS
Partial verification, 19 October 2026
Check for changes before acting.

Scope and limitations. This guide covers selected parts of the regulatory framework, not every applicable rule. It provides initial guidance based on the information you supply. It does not issue a legal classification, certify safety or authorize marketing, research or clinical use. The relevant authorities and institutional reviewers must assess your specific case. Local evaluation may be advisable, but there is no universal requirement to run a pilot.

Health AI in Peru.Know what to check.