Peru medical device registration timeline

Source-linked clocks

Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) classification system.

4 pathways4 of 4 clocks verifiedvalidity 5 years from the date of grant for every product and device in scope (art. 7 D.S. 016-2011-SA). Once the term lapses without reinscription DIGEMID places no restriction on continued use of biomedical equipment already acquired during the term.MDSAP not acceptedreviewed 2026-08-30cdn.www.gob.pe

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I(Notification) TUPA (D.S. 011-2026-SA): Clase I inscripción/reinscripción attended within 22 business days	22 working days	2-4 months	—	Verified
Class II(Registration) TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)	44 working days	4-8 months	3-5 months	Verified
Class III(Registration) TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)	66 working days	6-12 months	4-7 months	Verified
Class IV(Full Registration) TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)	66 working days	8-15 months	5-8 months	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Peru Medical Device Registration Process

Step-by-step DIGEMID registration process. Total estimated timeline: 2-4 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by DIGEMID. Appoint a Peru Registration Holder.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to DIGEMID including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

DIGEMID reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

22 working days

In-depth technical assessment of device safety and performance. DIGEMID may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, DIGEMID issues Peru market authorization certificate.

Summary: The Peru medical device registration process through Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

País de Alta Vigilancia Sanitaria (art. 9 D.S. 016-2011-SA): United States, Canada, Japan, Australia, Switzerland, South Korea, United Kingdom, Germany, France, Netherlands, Spain, Italy, Belgium, Portugal, Ireland, Austria, Hungary, Denmark, Norway, SwedenThe Peruvian route to relying on a foreign approval is documentary, not procedural. A certificate of free sale or a GMP certificate issued by a high-surveillance authority is accepted directly, and if the issuing authority appears on the Resolución Directoral 169-2014-DIGEMID list the document does not need an apostille. Everything else still goes through DIGEMID certification.None published — the TUPA period is set by class, not by origin

FDA 510(k)/PMAThe United States is a high-surveillance country, so a US certificate of free sale and GMP certificate are accepted on the terms above.None published

EU CE MarkAccepted where the certificate of free sale comes from one of the eleven EU or EFTA states on the high-surveillance list. A CE certificate from a notified body in a member state outside that list does not by itself carry the same standing.None published

ANVISA (Brazil)Brazil is neither a high-surveillance country under art. 9 nor a member of the Andean Community, so neither the documentary route nor CAN harmonisation applies to a Brazilian registration.None

Key requirements

Peru Registration Holder (for foreign manufacturers)
Spanish labeling and IFU
Free Sale Certificate
GMP certificate
Technical documentation
IVD registration/reinscription: 30 business days (TUPA); cambios (modifications): 30 business days; appeal windows per TUPA recursos rows

Primary regulator sources

cdn.www.gob.pe · DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods gob.pe · Peru D.S. 016-2011-SA — Reglamento para el Registro, Control y Vigilancia Sanitaria de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (arts. 7 and 9, as amended)

Reviewed 2026-08-30. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against DIGEMID publications · full review 2026-08-30 · row IDs are stable — cite as registration-timeline:peru:class-i