Peru R.D. N° 101-2019-DIGEMID Adverse Event Notification: Who Must Report and How

Regulatory information verified as of October 29, 2026

1. Key takeaways

R.D. N° 101-2019-DIGEMID-DG-MINSA (published on 2019-06-14) imposes the reporting duty for suspected adverse incidents involving medical devices on three categories of parties simultaneously: holders of sanitary registrations, holders of registration certificates, and medical professionals. This means a hospital-side report does not close the file for the registration holder — each of the three parties independently bears the notification duty. The most serious misjudgment we see in practice is the assumption that because the hospital has already reported, we no longer need to. Regulatory information verified as of October 29, 2026.

2. Legal basis

3. Expert insights

Insight 1 | Parallel reporting by three parties is a de-duplication design, not a substitution design

A single incident may simultaneously trigger the statutory notification on the registration holder side, the operational notification on the certified establishment side, and the clinical notification on the medical professional side. Mechanically, the competent authority seeks multi-source cross-validation: the hospital’s account reconstructs the clinical scene, while the holder’s account reconstructs the product batch and distribution scope; only in combination can they support a rapid determination of whether the problem is systemic. The three reporting channels are therefore parallel — if any one of them stays silent, that silence will be treated as an independent dereliction by that party in any later inspection. We require clients to maintain every internal ledger in a form that can be reconciled line by line against public notifications, rather than as verbal internal records.

Insight 2 | The layering between Titular del Registro Sanitario and registration certificate holder mirrors the certification structure

Product responsibility in Peru ultimately rests on the registration holder (Titular del Registro Sanitario, PRH), while the entity actually holding the certificate, importing and distributing may be another party. Secondary sources record that D.S. N° 020-2024-SA amended D.S. N° 016-2011-SA to decouple registration ownership from commercial distribution: an independent PRH may hold the registration while other qualified Droguería entities may separately obtain a CRS to import the same registered product. Because the original text in El Peruano has not been obtained, this item is marked across our publications as pending first-hand verification. Even under that structure, vigilance work cannot be pushed out on a whoever-imports-pays basis — our agreements fix in writing the deadlines for information return and the allocation of the burden of proof.

Insight 3 | The essence of format obligations is a machine-readable, traceable minimum dataset

Rules at the level of a directorial resolution usually govern in what format and with which fields a report is made. What the authority examines is whether product identification (name, registration number, model, batch or serial number), the event description, the consequence assessment, the place of occurrence and the reporting party can be extracted from the notification immediately. Under the practical estimate, a notification missing fields is returned for correction, and the original deadline does not pause while it is returned — that is where the format requirement does its real damage. We turn the mandatory fields into a fixed template and require distributors to submit by field, not by narrative.

4. Practical recommendations

1. Establish a unified notification data sheet whose fields cover at minimum product identification, registration number, batch or serial number, event description, consequence assessment, facility of occurrence, reporting party and time.
2. Set up a direct liaison channel with hospital sites, and incorporate the fact that medical professionals also report independently into product training materials to avoid information gaps.
3. Stipulate in distribution agreements that distributors must relay reports to the registration holder immediately upon receipt, with delayed relay constituting a breach of contract.
4. Perform a cross-source reconciliation monthly: compare the internal ledger against publicly available notification records; the gaps are the evidence of reporting links that need repair.
5. Retain all original submission receipts and acknowledgment numbers; in evidentiary proceedings rely on timestamps, not on email body text.
6. For clients affected by the certification-structure changes under D.S. N° 020-2024-SA, complete first-hand verification before re-registration or transfer, and never treat a secondary description as the basis of a plan.

5. Verification checklist

□ The obligated parties and format requirements for this notification have been confirmed and executed under R.D. N° 101-2019-DIGEMID-DG-MINSA (2019-06-14) (regulatory information verified as of October 29, 2026).

□ Our role — registration holder (PRH), certified distribution entity or other — has been confirmed and is consistent with the allocation of responsibilities in the agreements.

□ The notification form contains all core fields, with no blanks and no pending-supplement placeholders.

□ The user facility on site has been asked whether it has independently fulfilled its notification duty, and the communication records have been retained.

□ Serious incidents were handled within the 24-hour deadline; moderate and mild incidents were handled within the 20-calendar-day deadline.

□ Structural arrangements involving D.S. N° 020-2024-SA have been marked as pending first-hand verification and were not converted into firm commitments to clients.

□ All original receipts, acknowledgment numbers and timestamps have been archived.

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.