Peru Nuevo TUPA D.S. N° 011-2026-SA: 22/44/66-Day Review Clock Explained

Regulatory information verified as of October 29, 2026

1. Key takeaways

D.S. N° 011-2026-SA, published on 2026-07-21 in the official gazette El Peruano, approves the new Texto Único de Procedimientos Administrativos (TUPA) of the Ministry of Health (MINSA) and repeals the former D.S. N° 001-2016-SA and its subsequent amendments. The new procedure sets review clocks of 22 working days for Class I, 44 working days for Class II and 66 working days for Class III/IV, while in vitro diagnostics (IVD) follow a 30 working days clock (specific article numbers pending verification; official publications prevail). A compressed clock does not mean an enlarged margin for error: the deficiency-response window remains 30 working days, and failure to respond within that period constitutes grounds for denial. The practical reading is that preparation costs have shifted from the review stage to the pre-submission stage, and every template, form and fee ledger must be re-anchored to the new procedural text before the first submission under it.

2. Legal basis

Regulatory information verified as of October 29, 2026.

3. Expert insights

Insight 1: the TUPA is a procedural instrument, not a technical standard — it changes the runway, not the destination.

A unified procedure text answers how to submit, how long the authority has to reply, how much to pay and which form to use. It does not change what a product must demonstrate to be approved. After D.S. N° 011-2026-SA enters into force, classification is still determined under the 18 classification rules of D.S. N° 003-2020-SA, published on 2020-02-06, and technical dossiers are still organized under D.S. N° 016-2011-SA and its amendments. Reading the new TUPA as a signal that technical requirements have been relaxed leads companies to quietly lower their dossier standards, and the predictable result is that the very same document is returned even faster inside a shorter clock. The correct posture is to keep technical expectations constant while retooling the procedural shell around them.

Insight 2: the direct consequence of repealing the old TUPA is that old forms lapse, not old certificates.

The repeal of D.S. N° 001-2016-SA and its subsequent amendments affects the procedure table, requirement lists, fee rows and form versions. Certificates already issued, the Certificado de Registro Sanitario (CRS), and the rule that a sanitary registration is valid for 5 years derive from D.S. N° 016-2011-SA and do not lapse because the procedure text was replaced. Mechanically this is a separation of two layers of norms: the procedural layer iterates quickly, while the substantive layer remains comparatively stable. The corporate action is therefore to change forms without touching certificates — update internal submission templates and the fee ledger, and leave the compliance status of already registered products entirely undisturbed.

Insight 3: two clocks coexist, and the unit mismatch is where scheduling accidents happen.

Art. 136 sets assessment caps in calendar days — 30 for Class I, 60 for Class II, 90 for Class III/IV — while the new TUPA counts in working days: 22 / 44 / 66 working days, and 30 working days for IVD. Working days exclude rest days and public holidays, calendar days run continuously, and the two clocks also start from different points: the calendar-day caps constrain the assessment act itself, while the TUPA clocks constrain the procedural reply. Treating 90 calendar days and 66 working days as the same number will distort every delivery commitment built on them. Total project duration has no statutory basis, and we estimate on a practical estimate basis that Class III/IV typically run 4–8 months from acceptance to certificate, longer where deficiency responses occur.

Insight 4: a compressed clock moves preparation cost from after review to before it.

A reply window of 22 / 44 / 66 working days means the reviewer must complete the same technical judgment in less time, which makes first-round completeness of the dossier the decisive variable. The response window for Observaciones remains 30 working days and is not extended by the compression, and failure to respond in time constitutes grounds for denial (TUPA; specific article numbers pending verification; official publications prevail). The scheduling model therefore changes shape: clearing every deficiency trigger before submission is more efficient than racing through the response window afterward, because a single round of Observaciones can consume half of a Class I clock.

4. Practical recommendations

1. Manage the clocks with a dual table: register both the TUPA working-day clocks (22 / 44 / 66, IVD 30) and the Art. 136 calendar-day caps (30 / 60 / 90) in the internal schedule, using the former for progress tracking and the latter for compliance argument.
2. Verify templates against the 2026-07-21 dividing line: every application filed after that date uses the new TUPA forms and requirement lists, and forms from the D.S. N° 001-2016-SA framework are no longer applicable.
3. Front-load the deficiency contingency: complete an internal pre-review before submission, checking CFS validity, label drafts and technical report version numbers item by item, to reduce the probability of entering the 30 working days response window.
4. Re-verify fee rows: the TUPA fee schedule spans S/ 1,438.70 – S/ 2,176.40 on 2026 figures; map each payment node to its procedure row before paying.
5. Preserve proof of clock start: keep the acceptance receipt of the Solicitud Única de Comercio Exterior (SUCE) filed through the Ventanilla Única de Comercio Exterior (VUCE), as documentary evidence of the start date.
6. Treat the institutional change as background only: secondary sources record that D.S. N° 014-2026-SA was published on 2026-09-09 establishing a 90 calendar days institutional reorganization; while the reorganization proceeds, procedural readings follow official publications, and submissions should not be paused on that account.

5. Verification checklist

□ It has been confirmed that the current procedure text is D.S. N° 011-2026-SA (published 2026-07-21) and that D.S. N° 001-2016-SA and its subsequent amendments are repealed

□ Clocks have been registered by risk level: Class I 22, Class II 44, Class III/IV 66, IVD 30 working days

□ The Art. 136 calendar-day caps have been registered in parallel: Class I 30, Class II 60, Class III/IV 90

□ The deficiency-response window of 30 working days has been written into the project schedule with a named owner

□ All submission forms and requirement lists have been updated to the new TUPA version

□ Official fee rows and payment nodes have been verified (range S/ 1,438.70 – S/ 2,176.40, 2026 figures)

□ Submission acceptance receipts have been retained as evidence of the clock start date

Regulatory information verified as of October 29, 2026.

GRZAN Regulatory Team

GRZAN provides registration support in Peru for manufacturers, importers and authorized representatives, including procedure monitoring under the new TUPA and submission readiness reviews. Contact: info@grzanglobal.com