Peru Medical Device Regulatory System: DIGEMID, MINSA and Ley 29459

Regulatory information verified as of October 29, 2026.

1. Key takeaways

Regulatory authority over medical devices in Peru is split across two layers. The Ministry of Health, MINSA, sets the rules in its capacity as the National Health Authority (Autoridad Nacional de Salud, ANS), while the General Directorate of Medicines, Supplies and Drugs, DIGEMID, acts as the National Authority for Pharmaceutical Products, Medical Devices and Sanitary Products (Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios, ANM), executing the granting, control and vigilance of sanitary registrations. Ley N° 29459, published in the official gazette El Peruano on 2009-11-26, wrote this division of labor into the legal text. The windows companies face in daily operations for submissions, deficiency corrections and change filings belong to DIGEMID, while additions and deletions to the rules themselves arrive as Supreme Decrees signed by MINSA. Confusing the two layers is the most common structural error: its typical consequences are treating an oral answer given at a service window as a rule-based ground, or assuming that publication of a ministerial decree automatically means DIGEMID has already synchronized its implementing procedures. A disciplined compliance program therefore maps every question to the correct layer before any action is taken.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: The separation between rule-making power and case-level execution power determines the direction of remedies.

Rule changes in Peru do not arrive as window announcements from DIGEMID. They take the form of Supreme Decrees (Decreto Supremo) signed by MINSA and published in El Peruano. D.S. N° 011-2026-SA, published on 2026-07-21, approved the new consolidated text of administrative procedures and repealed the former D.S. N° 001-2016-SA; it is a typical sample of the mechanism. Authority over review clocks, documentary requirements, fees and forms rests with MINSA, and DIGEMID can only execute within the framework of the new text. This means that when a company disagrees with a review conclusion, the correct action is to follow the administrative procedure built by Ley N° 27444, published on 2001-04-11, through reconsideration and appeal, rather than negotiating a separate understanding with the executing department, because negotiation cannot produce effects that go beyond the procedures text.

Insight 2: ANM and ANS are functional designations, not agency renames.

The legal text uses the designation Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios to refer to the functions performed by DIGEMID, and Autoridad Nacional de Salud to refer to the functions performed by MINSA. The two sit at different levels of the same administrative chain: the ministerial body sets policy, and the directorate-level body implements it. From this follows a practical judgment: the issuing body printed on a sanitary registration certificate is DIGEMID, but the anchor of every statutory obligation behind that certificate is the set of duties that Ley N° 29459 imposes on the registration holder. A company cannot use the argument that the certificate was issued by the directorate to sever its responsibility to comply with ministerial decrees.

Insight 3: Organizational change affects process entry points, not the content of obligations.

Secondary sources record that D.S. N° 014-2026-SA was published on 2026-09-09, establishing an institutional reorganization arrangement lasting 90 calendar days. This item has not been verified against the original text in El Peruano and is mentioned here only as background: a reorganization is in progress, and procedural parameters should be confirmed against official publication. Mechanically, a reorganization changes the receiving units, service windows and internal routing paths; it does not change the obligations set by Ley N° 29459, nor the procedural requirements already fixed in the new TUPA. The appropriate corporate response is to track window announcements, not to pause submissions.

4. Practical recommendations

1. Build a dual-track tracking mechanism: follow laws and Supreme Decrees through MINSA and El Peruano, procedural requirements and forms through the current consolidated procedures text, and daily inquiries and case status through DIGEMID platforms. The three tracks do not update in sync.
2. Handle disputes through procedural law: when dissatisfied with a specific administrative decision, file reconsideration or appeal within the deadlines under Ley N° 27444 (published 2001-04-11) and the current TUPA, and avoid substituting oral communication for procedural steps.
3. Unify the names of institutional parties: in powers of attorney, free sale certificates and dossier covers, use the functional designations as they appear in the legal texts, avoiding self-created abbreviations that cause party-identification errors.
4. Map obligations to persons: assign sanitary registration, re-registration, change and vigilance duties to the registration holder, appoint a single in-country responsible party, and avoid responsibility gaps during reorganizations.
5. Treat reorganization information as background only: for actionable information about window changes, rely exclusively on current official DIGEMID publication, and do not adjust submission timing on the basis of industry database summaries.

5. Verification checklist

□ Confirmed that the direct receiving body for submissions, corrections and changes is DIGEMID (ANM)

□ Confirmed that the rule-making body for regulatory changes is MINSA (ANS), with El Peruano publication text as the controlling version

□ Confirmed that the current consolidated procedures text is D.S. N° 011-2026-SA (2026-07-21) and that D.S. N° 001-2016-SA has been repealed

□ Confirmed that authority designations are consistent across all external documents

□ Established a three-level tracking log covering ministerial decrees, procedures texts and window announcements

□ Confirmed that the remedy path is reconsideration (Reconsideración) and appeal (Apelación), registered in the deadline calendar

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.