Explore the medical device requirements currently available for Peru, organized by topic and linked to official sources.
What expires, what is retained periodically, and when must renewal start?
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'.
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).
Which current law, regulation, guidance, and transition provisions apply?
Devices are governed by Ley 29459 and Reglamento D.S. 016-2011-SA as amended by D.S. 016-2017-SA (which rewrote Arts. 12, 18, 26, 31, 40, 60, 62, 70, 81, 93, 94, 95, 104, 115, 124-127, 130, 132, 136 and repealed Art. 128), D.S. 018-2019-SA and D.S. 020-2024-SA (advertising Arts. 191-194, adds 194-A); classification and essential principles are set by D.S. 003-2020-SA.
D.S. 016-2017-SA published in El Peruano 07/06/2017.
Every mention of 'condiciones esenciales' or 'condiciones esenciales de seguridad y eficacia' in Title IV (Dispositivos Médicos) of D.S. 016-2011-SA is to be read as 'principios esenciales de seguridad y desempeño' under D.S. 003-2020-SA, with the Anexo 2 checklist (Art. 10) used as conformity evidence.
D.S. 003-2020-SA published 06/02/2020; per its final provisions it entered into force six months after publication.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
GHTF-aligned definition; IVD reagents/calibrators fall under the IVD carve-out until complementary regulation.
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.
Art. 122 also sets registration per device/manufacturer/country per GHTF and combination-device rules.
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.
D.S. 003-2020-SA Art. 9 likewise limits its essential principles to devices 'excepto los dispositivos médicos de diagnóstico in vitro'.
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.
Which registration, notification, listing, reliance, or conformity route applies?
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.
Issuance is an exclusive, non-delegable ANM power (same article).
Products manufactured in Peru exclusively for export are exempt from the Registro Sanitario requirement.
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.
Transfer requires copia legalizada o fedateada of the transfer document.
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.
Holder liability per Ley 29459 Art. 9: 'asume las mismas responsabilidades y obligaciones que el titular del registro sanitario'.
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.
Base legal of the IVD procedures includes D.S. 003-2020-SA Art. 10 and D.S. 008-2020-MINCETUR (VUCE).
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
D.S. 018-2019-SA subsequently added Austria to this list (as shown on DIGEMID's normas-legales repository).
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.
DIGEMID maintains and periodically publishes the list of competent certificate-issuing authorities.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
Solidary liability per Art. 58; holder responsibility per Art. 58 first paragraph.
Which establishment licences, importer permissions, and distribution controls apply?
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.
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.
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.
Which evidence, local deltas, formats, and signatures are required?
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.
Class II adds to the Class I set an ISO risk-management report ('Informe de gestión de riesgo, según norma ISO específica vigente'); on reinscripción items 4-8 are deemed submitted via sworn declaration of unchanged or authorized changes.
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.
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.
Which current form, portal, account, and submission package must be used?
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.
Sworn declaration framework per TUO Ley 27444 art. IV num. 1.16 (D.S. 004-2019-JUS), cited in the form.
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.
In-person hours: Monday-Friday 08:30-16:30.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
Label content requirements per Art. 138; single-use devices may not be re-used (Art. 139).
Which QMS, audit, inspection, and certificate scope is accepted or required?
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.
Same rule appears in Arts. 124, 125 and 127 numeral 3.
What review, validation, and applicant stop-clock rules apply?
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.
Golden-rule preservation of both rules; TUPA D.S. 011-2026-SA published 21/07/2026 is the current procedural instrument.
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.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
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.
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.
Which UDI, device listing, database, and traceability duties apply?
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.
Application-form identifier field per ficha TUPA 248.
Which clinical or IVD performance evidence or study is required and accepted?
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.
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.
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.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
Mirrors Ley 29459 Art. 16; Art. 20 text as modified by D.S. 016-2013-SA per DIGEMID FAQ.
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.
Filed at Mesa de Partes DIGEMID, Av. Parque de las Leyendas 246, San Miguel.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
What is reportable, by whom, where, in what format, and by what deadline?
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.
Te cnovigilancia operates within the Sistema Peruano de Farmacovigilancia (Ley Art. 35).
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.
NTS 123 approved by RM 539-2016-MINSA.
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.
Health professionals themselves report within 72 hours for mild/moderate cases (numeral 6.10 lit. b).
Which recall, FSCA, notice, and authority-coordination duties apply?
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).
Legal basis cited on the page: D.S. 013-2014-SA and RD 354-99-DG-DIGEMID.
Which claims, audiences, channels, approvals, and restrictions apply?
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.
Ley 29459 Arts. 39-41 provide the statute-level advertising restrictions.
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).
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.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
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.
