Peru Reinscripcion: Planning the Five-Year Registration Renewal Window

Regulatory information verified as of October 29, 2026

1. Key takeaways

The Peruvian sanitary registration (Registro Sanitario, RS) is valid for 5 years from the date of grant, and a re-registration (Reinscripción) application may be filed from 1 year before expiry — under Art. 7 of the Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (D.S. N° 016-2011-SA, published on 2011-07-27) and Art. 11 of the Ley de los Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (Ley N° 29459, published on 2009-11-26). The 1-year window is not a grace period but a planning period: the real difficulty lies in whether items 4 to 10 of the dossier can be claimed as exempt on the premise of being updated and approved, and in the fact that, under the 2026 consolidated administrative procedures text (Texto Único de Procedimientos Administrativos, TUPA), no answer before the statutory deadline expires is still treated as negative administrative silence and does not constitute approval. Regulatory information verified as of October 29, 2026.

2. Legal basis

Re-registration official fees (2026 TUPA basis): Class I S/ 1,405.40, Class II S/ 1,562.90; these fees are Category C data, and the fee schedule published by DIGEMID at the time prevails. The specific exemption list for items 4 to 10 has not been verified against definitive article numbers; the official publication prevails.

3. Expert insights

Insight 1 | The 1-year head start is a risk-management tool, not a queuing tool

The purpose of the window is to move uncertainty forward: the regulation allows filing from 1 year before expiry, so a company can run the full cycle of submission, observations, correction and approval before expiry, rather than staking business continuity on a single filing. Using it as an early placeholder with outdated documents is the most wasteful approach — once observations are issued, the time that could have served remediation is consumed instead. When scheduling for clients we normally set the actual filing point at 8 to 10 months before expiry, leaving the margin to correction.

Insight 2 | The trigger for exemption is status, not intent

Relief for items 4 to 10 depends on those documents being in an updated and approved state in the existing dossier; any item that has changed during the period without completing approval reverts to the normal channel requiring fresh submission. Mechanically this is a test of dossier continuity: submitting an unapproved change as if it were approved, once discovered in comparison, damages not only that item but the integrity assessment of the entire application. A mandatory pre-launch step for us is therefore an inventory of whether every change under the existing registration has been closed out.

Insight 3 | Technical requirements changed after 2020 — the highest-frequency rejection point for old dossiers

D.S. N° 003-2020-SA (2020-02-06) replaced experience-based classification with the 18 classification rules of Annex 1 and requires Class II to IV technical reports to attach a checklist of conformity with the essential principles of safety and performance (Principios Esenciales de Seguridad y Desempeño). Re-registration is not a resubmission of the file from five years ago: the classification basis has changed and the essential principles checklist requirement has changed, so dossiers built on old templates will be rejected under the new framework. The same review need applies after the 2017 amendments to the dossier articles (Art. 124, 125 and others) by D.S. N° 016-2017-SA.

4. Practical recommendations

1. Back-schedule from the expiry date in three phases: window opening at 1 year before expiry, actual filing at 8 to 10 months before expiry, and approval completed before expiry.
2. Inventory every change since the last approval (label, instructions for use, manufacturing site, raw materials, standard versions) and confirm whether each was filed and approved under D.S. N° 016-2011-SA.
3. Assess items 4 to 10 one by one for the updated-and-approved premise; any item not closed out is prepared as a complete fresh submission.
4. Redo the classification confirmation under the 18 rules of D.S. N° 003-2020-SA, and attach the essential principles conformity checklist for Class II to IV.
5. Budget against the 2026 TUPA fees for re-registration (Class I S/ 1,405.40, Class II S/ 1,562.90), with the current DIGEMID fee schedule prevailing.
6. After filing, manage expectations under the rule that no answer by the deadline is not approval: escalate through reconsideración or appeal rather than arranging shipments early.

5. Verification checklist

□ The 5-year validity and the re-registration window (from 1 year before expiry) have been confirmed under D.S. N° 016-2011-SA Art. 7 and Ley N° 29459 Art. 11 (regulatory information verified as of October 29, 2026).

□ The inventory of changes since the last approval has been completed, and all changes are confirmed closed and approved.

□ Items 4 to 10 have been assessed individually for the exemption premise; items not meeting it have complete fresh submissions ready.

□ The product classification has been re-verified against the 18 rules of D.S. N° 003-2020-SA.

□ The essential principles conformity checklist has been attached for Class II to IV.

□ The official fees have been checked against the 2026 TUPA basis, with the current DIGEMID fee schedule prevailing.

□ The team has been reminded that observations must be corrected within 30 working days, and that no answer by the deadline is treated as negative administrative silence and does not equal approval.

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.