Pure Global AI
DIGEMID · structured requirements

🇵🇪 Peru medical device regulatory data

Explore the medical device requirements currently available for Peru, organized by topic and linked to official sources.

52 facts22 dimensions10 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

Compare countries

No direct-to-patient promotion in health establishments

ads.health-establishment-promotion-ban
Fact-level verified

In health establishments it is prohibited to hand samples or free samples directly to patients and the public, or any other persuasion activity aimed at patients by medical visitors or company agents; companies may not install promotion modules, and medical visitors may not access consulting or hospitalization areas or interfere with health professionals' activities.

Conditions
  • Applies within establecimientos de salud; areas and schedules for representative access are set by establishment authorities.

OTC device ads must carry warnings and precautions

ads.otc-devices-warnings
Fact-level verified

Promotion and advertising of devices sold without prescription must state the main warnings and precautions corresponding to their registration; print-media ads must carry the technical information visibly and legibly proportionate to ad size (suggested minimum 8-point type).

Conditions
  • Applies to productos sanitarios y dispositivos médicos de venta sin receta médica (Art. 193-194).

Promotion of prescription devices requires informe técnico

ads.prescription-devices-informe-tecnico
Fact-level verified

Promotion and advertising of prescription (venta con receta médica) devices aimed at prescribing/dispensing professionals must include the device's informe técnico, presented legibly, visibly, truthfully, exactly, completely and updated; scientific/clinical information must be supported by and consistent with the registration. D.S. 020-2024-SA (published 25/10/2024) modified Arts. 191-194 and added Art. 194-A.

Conditions
  • Applies to devices classified as venta con receta médica (Classes III/IV are prescription/professional-use per Art. 134).

Ley 29459 Arts. 39-41 provide the statute-level advertising restrictions.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

Compare countries

Registration valid 5 years from grant

authorization.duration
Fact-level verified

The Registro Sanitario of devices within the Reglamento's scope is valid for five (5) years from the date of grant and is renewable ('El registro sanitario es temporal y renovable cada cinco años', Ley 29459 Art. 8); TUPA procedures likewise state authorization for 'cinco (05) años contados desde la fecha de su otorgamiento'.

Conditions
  • Applies to all device classes and to IVD procedures.

Reinscripción may be filed from one year before expiry

renewal.filing-window
Fact-level verified

The reinscripción application may be submitted from one year before expiry of the Registro Sanitario (Reglamento Art. 7; Ley 29459 Art. 11 likewise addresses timely reinscripción).

Conditions
  • Applies to all device classes.

Authority & regime

Which authority and binding regime govern this product, task, and date?

Compare countries

Competent authority for medical devices

authority.competent-authority
Fact-level verified

DIGEMID (Dirección General de Medicamentos, Insumos y Drogas), a line organ of the Ministry of Health, is the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) and is in charge nationwide of granting, renewing, amending, denying, suspending or cancelling the registro sanitario for medical devices.

Conditions
  • Applies to all device classes and to national and imported devices.

Baseline cited this authority via D.S. 016-2017-SA; the actual mandate is Art. 4 of the Reglamento D.S. 016-2011-SA. Ley 29459 Art. 2 likewise defines the ANM as 'actualmente Digemid'.

Directorate that decides device registrations

authority.issuing-directorate
Fact-level verified

Device registration decisions are formalized in a Resolución Directoral issued by the Dirección de Dispositivos Médicos y Productos Sanitarios of DIGEMID.

Conditions
  • Applies to inscripción, reinscripción and cambio procedures for medical devices and IVDs.

Wording appears in each device procedure of TUPA D.S. 011-2026-SA, Parte 2.

ANS/ANM structure under Ley 29459

authority.national-health-system
Fact-level verified

Under Ley 29459, the Autoridad Nacional de Salud (ANS) is the Ministry of Health, and the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) is DIGEMID; regional health authorities (ARS/ARM) and the ANM's decentralized organs share enforcement.

Conditions
  • Applies to products within the scope of Ley 29459.

Ley published in El Peruano 26/11/2009.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Registration changes approved by risk impact

changes.approval-by-risk
Fact-level verified

Changes to the device Registro Sanitario are granted according to their risk to health or their repercussions on quality, safety and efficacy; declared-information changes are filed with a declaration-jurida application plus supporting documents per specific directive. The TUPA 'Cambio en el Registro Sanitario de dispositivos médicos' procedure (PA9900E4FF, S/ 646.70, 30 business days) covers changes with significant repercussions on quality, safety or efficacy.

Conditions
  • Applies to post-authorization changes; minor-importance changes have a dedicated format (Formato de cambios de importancia menor).

TUPA base legal for the cambio procedure cites Reglamento Arts. 15, 17, 19, 41, 123, 132, 137, 138, 140; Ley 29459 Art. 14 additionally obliges holders to keep the registration file updated.

Agotamiento de stock must be requested within 30 days

changes.stock-exhaustion-window
Fact-level verified

The holder (or certificate holder) of an imported device may request authorization to exhaust stock of existing inventory within a period not exceeding 30 days of the triggering event, via declaration jurada identifying lots/series/identification codes, quantities, monthly sales average, and transit invoices where applicable.

Conditions
  • Applies to imported products/devices; cancellation at request requires the holder to retrieve market stock (Art. 13 closing paragraph).

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

Compare countries

Clinical evaluation report for Classes III/IV

clinical.evaluation-report-class-iii-iv
Fact-level verified

Class III and Class IV registration dossiers must include item 9 'Informe de evaluación clínica' (clinical evaluation report), alongside the ISO-specific risk-management report.

Conditions
  • Classes III and IV only (Arts. 126-127, 2017 texts); Class II requires the ISO risk report but not the clinical evaluation report.

Clinical investigations per Declaration of Helsinki

clinical.helsinki-requirement
Fact-level verified

Clinical investigations in humans for conformity with the essential principles must be conducted in accordance with the Declaration of Helsinki, from first consideration of need and justification through publication of results.

Conditions
  • Applies to clinical investigations supporting conformity of non-IVD devices.

Prototype devices restricted to research

clinical.prototypes-research-only
Fact-level verified

National or imported prototype devices and controlled-technology biomedical equipment may be authorized exclusively for research and experimentation and may never be used in healthcare delivery; import requires ANM authorization under health-research rules.

Conditions
  • Applies to dispositivos médicos y equipos biomédicos de tecnología controlada prototipo.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

Compare countries

Legal definition of medical device

definition.dispositivo-medico
Fact-level verified

A medical device is any instrument, apparatus, implement, machine, reagent or in-vitro calibrator, software application, material or other similar or related article intended by the manufacturer for use in humans, alone or in combination, for diagnosis, prevention, monitoring, treatment or alleviation of disease, injury compensation, anatomical/physiological support, life support, conception control, or disinfection of medical devices.

Conditions
  • Definition in Ley 29459 Art. 4 num. 3, applied to devices within DIGEMID's scope.

GHTF-aligned definition; IVD reagents/calibrators fall under the IVD carve-out until complementary regulation.

IVD analyzer equipment currently outside Registro Sanitario

scope.ivd-analyzer-registration-exclusion
Fact-level verified

In-vitro diagnostic devices remain governed by the Reglamento approved by D.S. 010-97-SA under the Primera Disposición Complementaria Transitoria of D.S. 001-2012-SA; per DIGEMID's official FAQ, IVD analyzer equipment (excluding reagent strips, cuvettes with reagents and IVD reagents) is currently not subject to Registro Sanitario.

Conditions
  • Excludes tiras reactivas, cubetas con reactivos y reactivos de diagnóstico in vitro; TUPA nevertheless maintains IVD inscripción/reinscripción procedures (see registration.ivd-procedures).

D.S. 003-2020-SA Art. 9 likewise limits its essential principles to devices 'excepto los dispositivos médicos de diagnóstico in vitro'.

Standalone software classified as active device

scope.standalone-software-active-device
Fact-level verified

Standalone software meeting the medical-device definition is considered an active medical device; software driving or influencing another device is classified by the intended use of the combination, and independent software per GHTF recommendations.

Conditions
  • Applies to software not incorporated in a device.

Art. 122 also sets registration per device/manufacturer/country per GHTF and combination-device rules.

Used/repowered biomedical equipment not registrable

scope.used-equipment-not-authorized
Fact-level verified

DIGEMID states current regulations do not contemplate authorization of used and/or repowered biomedical equipment, and it does not authorize import, marketing or use of such equipment in that condition.

Conditions
  • Applies to Equipo Biomédico Usado y/o repotenciado.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

Compare countries

Class I dossier requirements (Art. 124, 2017 text)

dossier.class-i
Fact-level verified

Class I registration: declaration-jurida application; free-sale certificate (imports); manufacturer BPM or equivalent quality certificate (CE, ISO 13485, FDA or others); informe técnico per Art. 130; technical studies (design verification/validation summary, declaration of conformity, certificate of analysis if any); labeling draft; instructions-for-use manual in Spanish. On reinscripción, items 4-7 are deemed submitted via sworn declaration that the technical information is unchanged or changes are authorized.

Conditions
  • Class I (bajo riesgo); imported products add simple Spanish translation of original-language documents.

Class III/IV dossier requirements (Arts. 126-127, 2017 text)

dossier.class-iii-iv
Fact-level verified

Classes III and IV further require, for sterile devices, copies of sterilization-process validation reports, an ISO-specific risk-management report, and item 9 'Informe de evaluación clínica' (clinical evaluation report), plus Spanish manual; on reinscripción items 4-10 are deemed submitted via sworn declaration.

Conditions
  • Class III (alto riesgo) and Class IV (críticos); sterilization validation only for sterile devices.

Foreign documents max 2 years old with simple Spanish translation

dossier.foreign-documents-validity
Fact-level verified

Documents issued abroad must be no older than two years from issuance (unless the document itself states a different validity) and must be accompanied by a simple (non-certified) translation into Spanish.

Conditions
  • Applies to all foreign-issued dossier documents.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

Director técnico requirement and shared quality liability

roles.director-tecnico
Fact-level verified

Device establishments (manufacture, import, export, storage, distribution, marketing, dispensing, sale) must have a director técnico who is a químico farmacéutico (or other professional where the Reglamento so provides); quality responsibility is shared solidarily between the director técnico and the establishment's legal representative, and the registration holder bears responsibility for device quality.

Conditions
  • Applies to all device establishments; professional per Reglamento for specific activities.

Solidary liability per Art. 58; holder responsibility per Art. 58 first paragraph.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

Compare countries

ANM certifies Buenas Prácticas compliance

establishment.bpm-certification-by-anm
Fact-level verified

Establishments must comply with applicable Buenas Prácticas (Manufactura, Laboratorio, Distribución, Almacenamiento, Dispensación, Seguimiento Farmacoterapéutico) and hold the corresponding certification; the ANM (DIGEMID) is the body that grants Buenas Prácticas certification to pharmaceutical establishments.

Conditions
  • Certification deadlines set by the Reglamento.

Prior sanitary authorization for device establishments

establishment.sanitary-authorization-required
Fact-level verified

Establishments manufacturing, importing, exporting, storing, distributing, marketing, dispensing or selling devices require prior sanitary authorization to operate, granted after inspection; the sanitary authorization is a precondition for municipal operating licenses.

Conditions
  • Applies per Art. 21 Ley 29459; device-specific rules in Arts. 59 ff.

IPEN authorization for ionizing-radiation equipment

import.ipen-authorization-ionizing-radiation
Fact-level verified

For controlled-technology biomedical equipment emitting ionizing radiation, import requires a copy of the import authorization issued by the Instituto Peruano de Energía Nuclear (IPEN) or the competent authority.

Conditions
  • Applies to equipos biomédicos de tecnología controlada that emit ionizing radiation.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Labels and IFU in Spanish

label.spanish-mandatory
Fact-level verified

Labeling of immediate and secondary packaging and instructions for use of medical devices must be expressed in Spanish, printed indelibly, legibly and visibly; other languages are additionally allowed provided the information matches what is registered; all devices must include instructions for use in their packaging except where exceptionally permitted, and IFU/manual content follows Art. 140.

Conditions
  • Applies to all device classes; symbols per Anexo 04 of D.S. 016-2011-SA.

Label content requirements per Art. 138; single-use devices may not be re-used (Art. 139).

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Periodic safety report schedule

pms.periodic-safety-report-schedule
Fact-level verified

Periodic safety reports are submitted: every six months during the first two years from authorization; annually for the following three years; and every five years from the sixth year onward. Device reports follow Art. 156 content; NTS 123 numeral 6.7(g) makes holders responsible for producing them under current norms.

Conditions
  • Applies to authorized products/devices; authority may request a risk-management plan (Art. 151).

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Official application form and device tables

forms.solicitud-dj-and-official-formats
Fact-level verified

Applications use the Solicitud-Declaración Jurada form capturing applicant category (laboratorio/droguería), RUC, director técnico, product group (DM / Equipo Biomédico / EBTC), universal nomenclature, and 'Código de Identificación (según el estándar internacional)'; requisito 9 requires the device table (Cuadro DM/DB/DBC or DMDIV) printed and on magnetic media. Official formats: Formato DMIMM-001, DMEB-002, DMDIV-003, FormatoDISMED_II.

Conditions
  • Per DIGEMID ficha TUPA 248 (Clase II) and the Formatos y Trámites page; equivalent fichas exist for other classes (246-255).

Sworn declaration framework per TUO Ley 27444 art. IV num. 1.16 (D.S. 004-2019-JUS), cited in the form.

VUCE electronic submission channel

portal.vuce-electronic-channel
Fact-level verified

Device registration procedures are filed electronically through the Ventanilla Única de Comercio Exterior (VUCE) at https://authorize.vuce.gob.pe/public/login-options/mercancias-restringidas, with in-person alternative at DIGEMID, Av. Parque de las Leyendas 240, San Miguel.

Conditions
  • Applies to all device inscripción/reinscripción/cambio procedures in the 2026 TUPA.

In-person hours: Monday-Friday 08:30-16:30.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

BPM or CE/ISO 13485/FDA quality evidence accepted

qms.quality-certificates-accepted
Fact-level verified

In lieu of a Peruvian BPM certificate from DIGEMID, applicants may submit a document evidencing compliance with quality norms specific to the device type by risk level, e.g. EC Certificate, current ISO 13485, FDA or others issued by the competent authority of the country of origin; manufacturers holding a valid DIGEMID BPM need only cite its certificate number in the sworn application.

Conditions
  • Applies to Classes I-IV (Arts. 124-127 numeral 3, 2017 texts).

Same rule appears in Arts. 124, 125 and 127 numeral 3.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

Field safety corrective action via Nota de Seguridad en Campo

recall.asc-nota-de-seguridad
Fact-level verified

Manufacturers' corrective actions (ASC - acción emprendida por un fabricante para reducir el riesgo de death or serious deterioration of a patient's health) are notified through a 'Nota de Seguridad en Campo'; CENAFyT coordinates processing, including VigiFlow-based management, and the ANM publishes alerts on unsafe products (Ley 29459 Art. 37).

Conditions
  • Applies to device safety issues requiring risk reduction in the field.

Legal basis cited on the page: D.S. 013-2014-SA and RD 354-99-DG-DIGEMID.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Only authorized laboratories and droguerías may apply

registration.applicant-establishments
Fact-level verified

Only holders of a sanitary authorization as a laboratorio (of pharmaceutical products, medical devices or sanitary products) or as a droguería may apply for the Registro Sanitario; a registration may be transferred to another qualifying party maintaining the same manufacturing installations and conditions.

Conditions
  • Applies to national and foreign-manufactured devices (foreign manufacturers act through a Peruvian laboratorio/droguería).

Transfer requires copia legalizada o fedateada of the transfer document.

TUPA maintains IVD inscripción/reinscripción procedures

registration.ivd-procedures
Fact-level verified

The 2026 MINSA TUPA includes dedicated procedures 'Inscripción/Reinscripción en el Registro Sanitario de Dispositivos Médicos de Diagnóstico In Vitro' (codes PA990002F5 and PA990033E4) for nationally or foreign-manufactured IVDs, with 30-business-day review.

Conditions
  • Coexists with the FAQ position that IVD analyzers without reagents are not subject to Registro Sanitario; reagents/strips/cuvettes are excluded from that exclusion.

Base legal of the IVD procedures includes D.S. 003-2020-SA Art. 10 and D.S. 008-2020-MINCETUR (VUCE).

Market-access route: mandatory Registro Sanitario by class

registration.market-access-route
Fact-level verified

All devices within the Article 6 classification require a Registro Sanitario, which authorizes manufacture, import, storage, distribution, marketing, promotion, dispensing, sale or use; the application is filed by class (I-IV, plus IVD) before DIGEMID with declaration-jurida application, free-sale certificate (imports), quality-system evidence and technical file.

Conditions
  • Applies to all classes; foreign products must hold a Peruvian-authorized establishment as applicant.

Issuance is an exclusive, non-delegable ANM power (same article).

Certificado de Registro Sanitario enables parallel import

registration.parallel-import-crs
Fact-level verified

An authorized droguería may obtain a Certificado de Registro Sanitario to import and market a device already registered by another holder (parallel import); DIGEMID issues it within 15 days, it expires with the parent registration, and the certificate holder assumes the same responsibilities and obligations as the registration holder.

Conditions
  • Applicant must be a droguería meeting Art. 8 conditions; product must have identical characteristics to the registered device.

Holder liability per Ley 29459 Art. 9: 'asume las mismas responsabilidades y obligaciones que el titular del registro sanitario'.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Peru approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Peru (11 records)

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class III

Id

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration

Official Timeline
Min

66

Max

66

Unit

working-days

Verification Status

official-verified

Official Source
Title

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Url

https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

Accessed Date

2026-08-25

Realistic Timeline
Min

6

Max

12

Unit

months

With Prior Approval
Min

4

Max

7

Unit

months

Prior Approval Benefits
  • FDA 510(k)/PMA
  • EU CE Mark
  • ANVISA
Notes
  • TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
  • Technical file review required
Clinical Trial Required

No

Local Testing Required

No

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · EU conformity assessment

Prior approval / evidence record

Class IV

Id

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Full Registration

Official Timeline
Min

66

Max

66

Unit

working-days

Verification Status

official-verified

Official Source
Title

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Url

https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

Accessed Date

2026-08-25

Realistic Timeline
Min

8

Max

15

Unit

months

With Prior Approval
Min

5

Max

8

Unit

months

Prior Approval Benefits
  • FDA PMA
  • EU CE Mark Class III
Notes
  • TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
  • All device procedures carry negative administrative silence (no deemed approval on lapse)
  • Clinical data may be required
Clinical Trial Required

Yes

Local Testing Required

No

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence
Pending verification
Statement

For imported devices of every class, D.S. 016-2011-SA Arts. 124–127 numeral 2 require a copy of the free-sale certificate issued by the competent authority of the country of origin or of the exporter; an NMPA certificate therefore satisfies this requirement for China-made devices. Under Art. 21, a certificate issued by an authority that does not appear on DIGEMID's published list of competent authorities is valid only if legalized by the Peruvian consulate (or the exporting country's embassy in Peru) attesting that the issuer is the competent authority.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

peru

China Classes In Scope

NMPA Class I filings and Class II/III certificates for DIGEMID device classes I, II, III and IV

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to imported devices, classes I–IV
  • If the CLV does not list models/brand/codes/dimensions, a manufacturer letter is accepted
  • Art. 21 consular-legalization fallback where the issuing authority is not on DIGEMID's list
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2011-07-27

Source passage: 2. Copia del certificado de libre comercialización emitido por la Autoridad competente del país de origen o exportador, para productos importados. ... (Art. 21) Se tiene por válido el certificado ... emitido por la autoridad competente del país de origen o exportador distinta a la que figura en dicho listado, siempre que cuente con la legalización del consulado peruano del lugar ... que acredite que es la Autoridad Competente.

PeruNMPA

Regulatory reference

China NMPA approval: not reference

reliance.china-nmpa-not-reference
Pending verification
Statement

D.S. 016-2011-SA Art. 9 fixes the closed list of 'países de alta vigilancia sanitaria' used throughout the regulation (for example acceptance of foreign GMP certificates in Arts. 22–23 and information sources for safety actions in Art. 13): France, Netherlands, United Kingdom, United States, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden. China is not on the list, so NMPA approvals or GMP certificates carry no high-vigilance status before DIGEMID.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

peru

China Classes In Scope

NMPA Class II/III certificates; target DIGEMID device classes I–IV (references to 'países de alta vigilancia sanitaria' for GMP acceptance and product-evidence purposes)

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • List is fixed by Art. 9 and may only change by Decreto Supremo
  • Arts. 22–23: foreign GMP certificates accepted only from high-vigilance countries or mutual-recognition countries
  • Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

Effective from 2011-07-27

Source passage: Artículo 9°.- Países de alta vigilancia sanitaria. Para efectos de lo señalado en la Ley y el presente Reglamento, se consideran como países de alta vigilancia sanitaria los siguientes: Francia, Holanda, Reino Unido, Estados Unidos de América, Canadá, Japón, Suiza, Alemania, España, Australia, Dinamarca, Italia, Noruega, Bélgica y Suecia.

PeruSource authority not specified

Regulatory reference

Free-sale certificates from unlisted authorities need consular legalization

reliance.consular-legalization-fallback
Fact-level verified

A free-sale certificate (or equivalent) issued by a competent authority not appearing on DIGEMID's published country list is accepted only if legalized by the Peruvian consulate in that place (or the exporting country's embassy in Peru) evidencing that the issuer is the competent authority.

Conditions
  • Applies when the issuing authority differs from the listed authority for that country.

DIGEMID maintains and periodically publishes the list of competent certificate-issuing authorities.

PeruAustralia TGA · Health Canada · Japan MHLW / PMDA · Swissmedic · US FDA · UK MHRA · France · Netherlands · Germany · Spain · Denmark · Italy · Norway · Belgium · Sweden

Regulatory reference

High-vigilance countries list for evidence

reliance.free-sale-high-vigilance-countries
Fact-level verified

For free-sale certificate and related evidence purposes, the high-vigilance countries are France, Netherlands, UK, USA, Canada, Japan, Switzerland, Germany, Spain, Australia, Denmark, Italy, Norway, Belgium and Sweden.

Conditions
  • List per Art. 9 D.S. 016-2011-SA.

D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).

PeruUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority

FDA 510(k)/PMA

Accepted

Yes

Benefit

The United States is a high-surveillance country, so a US certificate of free sale and GMP certificate are accepted on the terms above.

Timeline Savings

None published

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periodsPeru 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)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · EU conformity assessment · Brazil ANVISA

Prior approval / evidence record

Class II

Id

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Registration

Official Timeline
Min

44

Max

44

Unit

working-days

Verification Status

official-verified

Official Source
Title

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Url

https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

Accessed Date

2026-08-25

Realistic Timeline
Min

4

Max

8

Unit

months

With Prior Approval
Min

3

Max

5

Unit

months

Prior Approval Benefits
  • FDA 510(k)
  • EU CE Mark
  • ANVISA
Notes
  • TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
  • CAN harmonization applies
Clinical Trial Required

No

Local Testing Required

No

Gmp Required

Yes

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruBrazil ANVISA

Prior approval / evidence record

ANVISA (Brazil)

Authority

ANVISA (Brazil)

Accepted

No

Benefit

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.

Timeline Savings

None

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periodsPeru 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)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority

EU CE Mark

Accepted

Yes

Benefit

Accepted 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.

Timeline Savings

None published

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periodsPeru 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)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

PeruUS FDA · UK MHRA · Health Canada · Japan MHLW / PMDA · Australia TGA · Swissmedic · South Korea MFDS · Germany · France · Netherlands · Spain · Italy · Belgium · Portugal · Ireland · Austria · Hungary · Denmark · Norway · Sweden

Prior approval / evidence record

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, Sweden

Authority

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, Sweden

Accepted

Yes

Benefit

The 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.

Timeline Savings

None published — the TUPA period is set by class, not by origin

DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periodsPeru 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)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-30

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Negative administrative silence on device procedures

clocks.negative-administrative-silence
Fact-level verified

All device registration procedures are classified as 'Evaluación previa' with negative administrative silence: if the attention deadline lapses without an answer, the applicant may pursue administrative appeals rather than enjoying automatic approval.

Conditions
  • Applies to every DIGEMID device procedure in TUPA D.S. 011-2026-SA.

Statutory evaluation deadlines in calendar days (Art. 136)

clocks.statutory-review-caps
Fact-level verified

Statutory caps for evaluation of inscripción/reinscripción by risk class: Class I up to 30 calendar days; Class II up to 60 calendar days; Class III up to 90 calendar days; Class IV up to 90 calendar days (Art. 136 as replaced by D.S. 016-2017-SA). The 2026 TUPA states the operative deadlines in business days (22/44/66), which govern procedure administration.

Conditions
  • Two coexisting texts preserved: Art. 136 (calendario, 2017) vs TUPA 2026 (días hábiles); see typedFindings for TUPA rows.

Golden-rule preservation of both rules; TUPA D.S. 011-2026-SA published 21/07/2026 is the current procedural instrument.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Exceptional authorization cases for unregistered devices

special.exceptional-authorization-cases
Fact-level verified

The ANS through the ANM may provisionally authorize import, manufacture and use of devices without registration or outside registered conditions in five qualified cases: (a) declared urgency/emergency; (b) research exclusively; (c) training exclusively (devices only, time-limited, authorized educational institution); (d) individual prevention/treatment with medical justification; (e) public-health situations demonstrating need and non-availability. Cases b/c/d require a declaration-jurida application plus supporting documents.

Conditions
  • ANM retains verification and quality-check powers over products in national territory (Ley Art. 16 final paragraph).

Mirrors Ley 29459 Art. 16; Art. 20 text as modified by D.S. 016-2013-SA per DIGEMID FAQ.

Visación de receta individual import route

special.visacion-de-receta
Fact-level verified

Individual patients may import an unregistered device needed for their treatment through the 'Autorización Excepcional de Importación' with Visación de Receta, limited to prevention, individual treatment and emergency cases; it applies to natural persons for exclusive use of the patient, requires the medical prescription plus declaration jurada and a device-characteristics report, and is free of charge.

Conditions
  • Natural persons only; collective-treatment devices excluded; per Art. 20 D.S. 016-2011-SA as modified by D.S. 016-2013-SA; prescription per Art. 56 D.S. 014-2011-SA.

Filed at Mesa de Partes DIGEMID, Av. Parque de las Leyendas 246, San Miguel.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Appeal instances for device decisions

appeal.instances-device-procedures
Fact-level verified

For device procedures, Reconsideración is filed and answered before the Director(a) Ejecutivo(a) of the Dirección de Dispositivos Médicos y Productos Sanitarios (max 15 business days to file, 15 to resolve); Apelación goes to the Director(a) General of DIGEMID (15 business days to file, 30 to resolve). Reconsideración requires new evidence; Apelación covers differing interpretation of evidence or pure-law questions.

Conditions
  • Per TUPA D.S. 011-2026-SA resources section of each device procedure.

Observations must be cured within 30 business days

deficiency.subsanacion-30-business-days
Fact-level verified

Where DIGEMID raises observations to documentation or technical information in inscripción/reinscripción, failure to cure them within a maximum of 30 business days from notification is a ground for suspension or cancellation of the registration.

Conditions
  • Extension possible when the nature of the observation requires more time, supported, and not exceeding the registration's validity (Art. 13 closing).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Single national identification standard and traceability duty

traceability.single-identification-standard
Fact-level verified

The ANM establishes and publishes a single product identification standard for pharmaceuticals, devices and sanitary products, mandatory nationwide; establishments that manufacture, import, distribute and market devices must implement a system to achieve traceability of products placed on the national market, under conditions set by the Reglamento. The application form requires the device's identification code under the international standard.

Conditions
  • Applies to market participants; deadlines per Reglamento.

Application-form identifier field per ficha TUPA 248.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Holder duty to report adverse events

vigilance.holder-reporting-duty
Fact-level verified

Manufacturers, importers and registration holders must report to the ANM suspicions of adverse reactions and events for the products they manufacture or market; health professionals and establishments must likewise notify. Holders are integrants of the Sistema Peruano de Farmacovigilancia (D.S. 013-2014-SA Art. 1), whose activities are regulated by RM-level technical standards.

Conditions
  • Applies to titulares de registro sanitario y certificado de registro sanitario.

Te cnovigilancia operates within the Sistema Peruano de Farmacovigilancia (Ley Art. 35).

Mild/moderate adverse incidents within 20 calendar days

vigilance.mild-moderate-20d
Fact-level verified

Suspicions of mild and moderate adverse reactions or incidents must be submitted within no more than 20 calendar days of becoming aware, in ANM-approved formats.

Conditions
  • Per NTS 123 numeral 6.7 k.2 (registration/certificate holders).

Health professionals themselves report within 72 hours for mild/moderate cases (numeral 6.10 lit. b).

Serious adverse incidents reportable within 24 hours

vigilance.serious-24h
Fact-level verified

Registration and certificate holders must report suspicions of serious adverse reactions and incidents within 24 hours of becoming aware, using ANM-approved formats and available communication means, and must additionally submit the investigation report of the serious case within 10 calendar days of receiving the notification. Public-health-risk lots must also be communicated within 24 hours (numeral 6.7 m). DIGEMID's NotiMED platform is used for serious reports.

Conditions
  • Per NTS 123 numeral 6.7 k.1; confirmed by Comunicado DIGEMID N° 005-2025 for serious ADRs.

NTS 123 approved by RM 539-2016-MINSA.

Related structured datasets

Classification systems · 1 record
Open Risk classes I through IV. →
Id

peru:medical-device

Jurisdiction Id

peru

Domains
  • medical-device
  • ivd
Name

Risk classes I through IV.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    ii

    Label

    Class II

    Normalized Risk Level

    medium

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    high

  • Id

    iv

    Label

    Class IV

    Normalized Risk Level

    highest

Regulator

DIGEMID

Official Domains
  • digemid.minsa.gob.pe
  • gob.pe
  • cdn.www.gob.pe
Source Status

official-source-verified

Source Title

Decreto Supremo 003-2020-SA, Arts. 4-6 y Anexo 1 (reglas de clasificación)

Source Url

https://cdn.www.gob.pe/uploads/document/file/521021/decreto-supremo-003-2020-SA.PDF

Verified On

2026-08-25

Source Supports
  • class-axis
  • classification-rules
Notes
  • Four classes per Art. 4 (I bajo, II moderado, III alto, IV crítico), consistent with Ley 29459 Art. 6 and D.S. 016-2011-SA; GHTF-derived rules in Anexo 1; the highest applicable rule governs when two or more rules apply.
  • The manufacturer classifies (Art. 6) and the ANM may reclassify; accessories and combination components are classified separately.
  • Software: software influencing another device is classified by the combination's intended use; standalone software is an active medical device (D.S. 016-2011-SA Art. 122 as complemented by software rules d.1/d.2).
Registration pathways, prior approvals and planning · 1 record
Open Peru registration →
Country

Peru

Jurisdiction Id

peru

Country Code

PE

Flag

🇵🇪

Regulator

Dirección General de Medicamentos, Insumos y Drogas

Regulator Abbrev

DIGEMID

Region

americas

Tier

3

Risk Classification

4-class (I, II, III, IV)

Classes
  • Id

    class-i

    Class Name

    Class I

    Risk Level

    low

    Pathway

    Notification

    Official Timeline
    Min

    22

    Max

    22

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

    Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    2

    Max

    4

    Unit

    months

    Notes
    • TUPA (D.S. 011-2026-SA): Clase I inscripción/reinscripción attended within 22 business days
    • Statutory calendar-day cap still in force in parallel: 30 calendar days (D.S. 016-2017-SA Art. 136)
    • Simplified notification process
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    class-ii

    Class Name

    Class II

    Risk Level

    medium

    Pathway

    Registration

    Official Timeline
    Min

    44

    Max

    44

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

    Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    4

    Max

    8

    Unit

    months

    With Prior Approval
    Min

    3

    Max

    5

    Unit

    months

    Prior Approval Benefits
    • FDA 510(k)
    • EU CE Mark
    • ANVISA
    Notes
    • TUPA (D.S. 011-2026-SA): Clase II within 44 business days; statutory parallel cap 60 calendar days (Art. 136)
    • CAN harmonization applies
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-iii

    Class Name

    Class III

    Risk Level

    high

    Pathway

    Registration

    Official Timeline
    Min

    66

    Max

    66

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

    Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    12

    Unit

    months

    With Prior Approval
    Min

    4

    Max

    7

    Unit

    months

    Prior Approval Benefits
    • FDA 510(k)/PMA
    • EU CE Mark
    • ANVISA
    Notes
    • TUPA (D.S. 011-2026-SA): Clase III within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
    • Technical file review required
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

  • Id

    class-iv

    Class Name

    Class IV

    Risk Level

    highest

    Pathway

    Full Registration

    Official Timeline
    Min

    66

    Max

    66

    Unit

    working-days

    Verification Status

    official-verified

    Official Source
    Title

    DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

    Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Accessed Date

    2026-08-25

    Realistic Timeline
    Min

    8

    Max

    15

    Unit

    months

    With Prior Approval
    Min

    5

    Max

    8

    Unit

    months

    Prior Approval Benefits
    • FDA PMA
    • EU CE Mark Class III
    Notes
    • TUPA (D.S. 011-2026-SA): Clase IV within 66 business days; statutory parallel cap 90 calendar days (Art. 136)
    • All device procedures carry negative administrative silence (no deemed approval on lapse)
    • Clinical data may be required
    Clinical Trial Required

    Yes

    Local Testing Required

    No

    Gmp Required

    Yes

Prior Approvals
  • Authority

    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, Sweden

    Accepted

    Yes

    Benefit

    The 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.

    Timeline Savings

    None published — the TUPA period is set by class, not by origin

  • Authority

    FDA 510(k)/PMA

    Accepted

    Yes

    Benefit

    The United States is a high-surveillance country, so a US certificate of free sale and GMP certificate are accepted on the terms above.

    Timeline Savings

    None published

  • Authority

    EU CE Mark

    Accepted

    Yes

    Benefit

    Accepted 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.

    Timeline Savings

    None published

  • Authority

    ANVISA (Brazil)

    Accepted

    No

    Benefit

    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.

    Timeline Savings

    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
Local Rep Required

Yes

Local Rep Name

Peru Registration Holder

Mdsap Accepted

No

Mdsap Benefit

Not accepted. The GMP evidence DIGEMID accepts without further certification is a certificate from a high-surveillance authority, not an MDSAP report.

Registration Validity

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.

Verification Status

official-verified

Official Sources
  • Title

    DIGEMID TUPA (D.S. 011-2026-SA) — device procedure attention periods

    Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Accessed Date

    2026-08-25

  • Title

    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)

    Url

    https://www.gob.pe/institucion/minsa/normas-legales/243290-016-2011-sa

    Accessed Date

    2026-08-30

Reviewed On

2026-08-30

Last Updated

2026-08-30

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

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

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

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

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

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

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

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

    Duration

    22 working days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, DIGEMID issues Peru market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Peru fees →
Jurisdiction Id

peru

Country

Peru

Country Code

PE

Authority

DIGEMID / VUCE

Low Risk Local
Min

1438.7

Max

1438.7

Currency

PEN

Per Product

No

High Risk Local
Min

2176.4

Max

2176.4

Currency

PEN

Per Product

No

Details
  • Id

    registration-class-1

    Item

    Registration (inscripción) - Class I medical device

    Currency

    PEN

    Amount Local

    1438.7

    Amount Local Formatted

    PEN 1,438.70

    Frequency

    Per application (procedure PA990006DD)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    re-registration-class-1

    Item

    Re-registration (reinscripción) - Class I medical device

    Currency

    PEN

    Amount Local

    1405.4

    Amount Local Formatted

    PEN 1,405.40

    Frequency

    Per application (procedure PA9900DDA7)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    registration-class-2

    Item

    Registration - Class II medical device

    Currency

    PEN

    Amount Local

    1593.2

    Amount Local Formatted

    PEN 1,593.20

    Frequency

    Per application (procedure PA99008E39)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    re-registration-class-2

    Item

    Re-registration - Class II medical device

    Currency

    PEN

    Amount Local

    1562.9

    Amount Local Formatted

    PEN 1,562.90

    Frequency

    Per application (procedure PA990012F8)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    registration-class-3

    Item

    Registration - Class III medical device (high risk)

    Currency

    PEN

    Amount Local

    1948.4

    Amount Local Formatted

    PEN 1,948.40

    Frequency

    Per application (procedure PA990049F8)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    re-registration-class-3

    Item

    Re-registration - Class III medical device

    Currency

    PEN

    Amount Local

    1806.9

    Amount Local Formatted

    PEN 1,806.90

    Frequency

    Per application (procedure PA9900B054)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    registration-class-4

    Item

    Registration - Class IV medical device (critical risk)

    Currency

    PEN

    Amount Local

    2176.4

    Amount Local Formatted

    PEN 2,176.40

    Frequency

    Per application (procedure PA99006495)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    re-registration-class-4

    Item

    Re-registration - Class IV medical device

    Currency

    PEN

    Amount Local

    2138.4

    Amount Local Formatted

    PEN 2,138.40

    Frequency

    Per application (procedure PA990011832)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    registration-ivd

    Item

    Registration - in-vitro diagnostic device

    Currency

    PEN

    Amount Local

    1965.1

    Amount Local Formatted

    PEN 1,965.10

    Frequency

    Per application (procedure PA990002F5)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    re-registration-ivd

    Item

    Re-registration - in-vitro diagnostic device

    Currency

    PEN

    Amount Local

    1915.1

    Amount Local Formatted

    PEN 1,915.10

    Frequency

    Per application (procedure PA990033E4)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

  • Id

    registration-change-significant

    Item

    Change to the sanitary registration - significant repercussion on quality, safety, or efficacy

    Currency

    PEN

    Amount Local

    646.7

    Amount Local Formatted

    PEN 646.70

    Frequency

    Per application (procedure PA9900E4FF)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Source Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Source Effective Date

    2026-07-21

    Verified On

    2026-08-25

Notes
  • TUPA D.S. 011-2026-SA has applied since its publication on 21 July 2026 and lists these exact amounts for the DIGEMID device procedures in VUCE.
  • Amounts are payable at the entidad cashier (Caja de la Entidad) per procedure code shown in the frequency field.
  • Import, export, and certificate procedures carry separate TUPA rows not listed here.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Peru TUPA D.S. 011-2026-SA, Parte 2: medical-device registration procedures

    Url

    https://cdn.www.gob.pe/uploads/document/file/10349703/8409411-tupa-parte-2.pdf

    Effective Date

    2026-07-21

    Accessed Date

    2026-08-25

  • Title

    Peru VUCE TUPA 119: sanitary-registration certificate for pharmaceuticals and medical devices

    Url

    https://www.vuce.gob.pe/Paginas/Catalogo-de-servicios-detalle.aspx?idCategoria=3&idDetalle=325

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Peru certifications →
Slug

peru

Market

Peru

Confidence

low

Schemes
  • Id

    digemid-electrical-emc-evidence

    Name

    DIGEMID electrical/EMC evidence

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Registration accepts quality-system evidence in lieu of Peruvian BPM: EC (CE) certificate, current ISO 13485, FDA or others by risk level issued by the country-of-origin authority (D.S. 016-2017-SA Art. 126 num. 3); sterile class III/IV devices submit sterilization-process validation reports (Art. 126 num. 6); classes II-IV need an ISO-specific risk-management report (Arts. 125 num. 7 / 126 num. 8).

    Source Urls
    • https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2017/DS_016-2017.pdf
    Source Binding

    reviewed

  • Id

    mtc-rf-emitting-equipment-homologation

    Name

    MTC RF-emitting equipment homologation

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Emitting Equipment

    Source Urls
    • https://www.gob.pe/institucion/mtc/colecciones/334-homologacion-de-equipos-de-telecomunicaciones
    Source Binding

    candidate

  • Id

    mtc-public-network-equipment-homologation

    Name

    MTC public-network equipment homologation

    Category

    Telecom Network Attachment

    Status

    Mandatory If Feature

    Object

    Public Network Terminal

    Source Urls
    • https://www.gob.pe/institucion/mtc/colecciones/334-homologacion-de-equipos-de-telecomunicaciones
    Source Binding

    candidate

  • Id

    ipen-radiation-authorization

    Name

    IPEN radiation authorization

    Category

    Ionizing Radiation

    Status

    Mandatory If Feature

    Object

    Product And Use Site

    Note

    D.S. 016-2011-SA Art. 24 num. 7: registration of ionizing-radiation emitting controlled-technology biomedical equipment requires a copy of the IPEN (Instituto Peruano de Energía Nuclear) import authorization.

    Source Urls
    • https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2011/DS_016-2011.pdf
    Source Binding

    candidate

Official Sources
  • Authority

    MTC

    Topic

    telecommunications equipment homologation collection

    Url

    https://www.gob.pe/institucion/mtc/colecciones/334-homologacion-de-equipos-de-telecomunicaciones

  • Authority

    MTC

    Topic

    RF-emitting equipment certificate

    Url

    https://www.gob.pe/institucion/mtc/pages/22738-solicitar-certificado-de-homologacion-para-un-equipo-y-o-aparato-de-telecomunicaciones-que-genera-emisiones-radioelectricas

  • Authority

    DIGEMID

    Topic

    D.S. 016-2017-SA registration dossier quality-system and sterilization evidence

    Url

    https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2017/DS_016-2017.pdf

  • Authority

    DIGEMID

    Topic

    D.S. 016-2011-SA IPEN import authorization for radiation equipment

    Url

    https://www.digemid.minsa.gob.pe/Archivos/Normatividad/2011/DS_016-2011.pdf

Keep researching this market

More Peru medical device resources

View the Peru resource hub →
Compare regulatory data across all countries →
Continue with this market
DJ Fang
Need to apply Peru's requirements to a product?
Confirm the current DIGEMID pathway, evidence, and local-role details for the actual device before filing.
Pricing