Peru Medical Device Official Fees: 2026 TUPA Registration Cost Guide

Regulatory information verified as of October 29, 2026

1. Key takeaways

The official fees for Peruvian medical device sanitary registrations (Registro Sanitario, RS) are uniformly set out in the Texto Único de Procedimientos Administrativos (TUPA) approved by D.S. N° 011-2026-SA (Nuevo Texto Único de Procedimientos Administrativos (TUPA) del MINSA, published on 2026-07-21 in El Peruano), and are listed as fixed sol amounts. The current figures are: Class I registration S/ 1,438.70, Class I re-registration (Reinscripción) S/ 1,405.40, Class II registration S/ 1,593.20, Class II re-registration S/ 1,562.90, with the overall range spanning S/ 1,438.70 – S/ 2,176.40. Because fees are attached to procedure lines rather than to products, budgeting must be organized around the specific procedural action that will actually be filed, and the same device can generate different fee totals depending on whether it enters as a first registration, a re-registration, a change, or a transfer.

GRZAN points out that official fees are only part of the cash cost; what really affects the project budget is whether the payment milestone matches the procedural status. A payment made at the wrong milestone is not refunded, nor does it pause the review clock.

2. Legal basis

Regulatory information verified as of October 29, 2026. The four official fees and the range above are taken from the 2026 TUPA fee tables and constitute Category C data (official or semi-official data; individual line items not verified one by one).

3. Expert insights

Insight one: official fees are priced by procedural action, not by product value. The TUPA splits registration and re-registration into two independent fee lines: the Class I registration at S/ 1,438.70 is higher than the Class I re-registration at S/ 1,405.40, and the Class II registration at S/ 1,593.20 is higher than the Class II re-registration at S/ 1,562.90. The mechanical meaning is that a first registration includes a full technical review, while a re-registration is a continuity review of an existing registration, and the different review effort drives the different pricing. This explains why a re-registration cannot reuse the payment receipt of the original registration, and why other procedures such as changes and transfers carry their own fee lines.

Insight two: the upper bound of the range, S/ 2,176.40, signals more than a difference in risk class. The overall range of S/ 1,438.70 – S/ 2,176.40 covers all TUPA fee lines; the upper bound sits above the disclosed Class I/II values, and the difference corresponds to higher risk classes and additional procedures. GRZAN runs budget stress tests at the upper bound of the range rather than extrapolating the budget of all projects from the Class I value.

Insight three: official fees are listed as fixed sol amounts and belong to a different measure than the UIT system. The 2026 UIT is S/ 5,500 (D.S. N° 301-2025-EF, published on 2025-12-17, effective from 2026-01-01). The UIT is mainly used in scenarios calculated by reference units, such as sanctions, while TUPA official fees are stated directly in sol amounts. The two do not need to be converted into each other, and official fees should not be interpreted as UIT multiples.

Insight four: the repeal of the old TUPA by D.S. N° 011-2026-SA means historical fee rates cannot be carried over. The new TUPA repeals D.S. N° 001-2016-SA and its subsequent amendments, and uniformly governs procedures, requirements, deadlines, fees, and forms. Mechanically, fees and procedures are bound within the same instrument, so a change of procedure is a change of fee basis. Any quotation model that still cites the 2016 TUPA rates needs to be recalibrated. For this engagement the sol (S/) is the only pricing currency for official fees; no equivalent conversion into other currencies is provided, and any internal accounting that requires conversion must state the exchange rate date and source, as the exchange rate basis is uncertain.

4. Practical recommendations

1. Budget by separate line items: Class I registration S/ 1,438.70, Class I re-registration S/ 1,405.40, Class II registration S/ 1,593.20, Class II re-registration S/ 1,562.90; do not use merged estimates.
2. Use the upper bound of the range, S/ 2,176.40, for stress tests covering higher risk classes and additional procedures.
3. Verify fee lines and procedure codes item by item in the current TUPA of D.S. N° 011-2026-SA, and do not carry over the old rates of D.S. N° 001-2016-SA.
4. Confirm the payment milestone in step with the submission action, and archive the payment receipt number together with the application documents.
5. Book official fees in sol, and do not use amounts converted into other currencies as the basis of quotations; where conversion is unavoidable, state the exchange rate date and source.
6. For re-registration projects, plan fees and documents early within the window opening 1 year before expiry (D.S. N° 016-2011-SA Art. 7; Ley N° 29459 Art. 11).

5. Verification checklist

□ The Class I registration fee of S/ 1,438.70 has been checked against the current TUPA of D.S. N° 011-2026-SA.

□ The Class I re-registration fee of S/ 1,405.40 and the Class II registration fee of S/ 1,593.20 have been checked.

□ The Class II re-registration fee of S/ 1,562.90 has been checked.

□ The overall range of S/ 1,438.70 – S/ 2,176.40 has been confirmed for budget stress testing.

□ The official fee values have been confirmed as Category C data, with individual line items not verified one by one.

□ It has been confirmed that the old rates of D.S. N° 001-2016-SA are not in use.

□ It has been stated that official fees are priced in sol, with no equivalent conversion into other currencies provided.

□ Regulatory information verified as of October 29, 2026.

Regulatory information verified as of October 29, 2026.

GRZAN provides medical device registration support in Peru for manufacturers, importers, and authorized representatives. For inquiries, contact info@grzanglobal.com.

*GRZAN Regulatory Affairs Team*