DIGEMID · Americas

Peru medical device regulatory resources

Every Peru dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

28,075 dated authorization records11 free resources24/25 topics with records14 regulations trackedAug 2026 fees reviewed

Search the device database Run the classification agent

Read the maintained Peru market guide on Pure Global ↗

Everything we track for Peru

Medical device registration database

Search official DIGEMID device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official DIGEMID regulations and guidance documents.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Government registration fees

Review current DIGEMID application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely DIGEMID pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent DIGEMID policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary DIGEMID risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Peru requirements.

AI similar registered product finder

Describe a device and find comparable products in the DIGEMID registration database.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Peru. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Source-linked rules available
How do I update a manufacturer's name without changing the legal entity? →Source-linked rules available
What changes when the manufacturer's office address changes? →Source-linked rules available
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Source-linked rules available
Can several changes be filed together? →Source-linked rules available

Structured regulatory requirements

Explore all 59 source-linked facts →

24 of 25 research dimensions currently covered · 14 official sources · latest verification 2026-10-26

Market entry

D01

Authority & regime

Verified

Competent authority for medical devices: 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…
ANS/ANM structure under Ley 29459: 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…

3 source-linked facts

Checked 2026-10-26

Open details →

D02

Legal basis & guidance

Verified

Current device legal framework: 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,…
Essential principles replace 'condiciones esenciales': 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…

2 source-linked facts

Checked 2026-08-25

Open details →

D03

Device definition & scope

Verified

Legal definition of medical device: 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 manufac…
IVD analyzer equipment currently outside Registro Sanitario: 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…

4 source-linked facts

Checked 2026-08-25

Open details →

D04

Classification rules

Verified

Risk classes I through IV.: Class I, Class II, Class III, Class IV

1 maintained scheme

Checked 2026-08-25

Open details →

D05

Registration pathways

Verified

Only authorized laboratories and droguerías may apply: 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 regist…
Export-only products exempt from registration: Products manufactured in Peru exclusively for export are exempt from the Registro Sanitario requirement.

5 source-linked facts

Checked 2026-08-25

Open details →

D06

Reliance & recognition

Verified

Free-sale certificates from unlisted authorities need consular legalization: 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 pla…
High-vigilance countries list for evidence: 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…

4 source-linked facts

Checked 2026-09-15

Open details →

D07

Economic-operator roles

Verified

Director técnico requirement and shared quality liability: Device establishments (manufacture, import, export, storage, distribution, marketing, dispensing, sale) must have a director técnico who is a químico farmacéutico (or other professional whe…

1 source-linked fact

Checked 2026-08-25

Open details →

D08

Establishment, import & distribution

Verified

ANM certifies Buenas Prácticas compliance: Establishments must comply with applicable Buenas Prácticas (Manufactura, Laboratorio, Distribución, Almacenamiento, Dispensación, Seguimiento Farmacoterapéutico) and hold the corresponding…
Prior sanitary authorization for device establishments: Establishments manufacturing, importing, exporting, storing, distributing, marketing, dispensing or selling devices require prior sanitary authorization to operate, granted after inspection…

3 source-linked facts

Checked 2026-08-25

Open details →

D09

Dossier requirements

Verified

Class I dossier requirements (Art. 124, 2017 text): 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…
Class II dossier requirements (Art. 125, 2017 text): 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 swor…

5 source-linked facts

Checked 2026-10-26

Open details →

D10

Official forms & portals

Verified

Official application form and device tables: Applications use the Solicitud Declaración Jurada form capturing applicant category (laboratorio/droguería), RUC, director técnico, product group (DM / Equipo Biomédico / EBTC), universal n…
VUCE electronic submission channel: Device registration procedures are filed electronically through the Ventanilla Única de Comercio Exterior (VUCE) at https://authorize.vuce.gob.pe/public/login options/mercancias restringida…

2 source-linked facts

Checked 2026-08-25

Open details →

Submission & evidence

D11

Label, IFU & language

Verified

Labels and IFU in Spanish: 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 additiona…
Artwork-only label/IFU changes: Section 1.3 permits artwork/form changes without changing the information authorized under Articles 138 and 140 of DS 016 2011 SA as amended. Examples are color, size, font, foreign authori…

3 source-linked facts

Checked 2026-10-26

Open details →

D12

QMS, audit & inspection

Verified

BPM or CE/ISO 13485/FDA quality evidence accepted: 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,…

1 source-linked fact

Checked 2026-08-25

Open details →

D13

Standards, testing & ancillary approvals

Unresolved

DIGEMID electrical/EMC evidence: Electrical safety
MTC RF-emitting equipment homologation: Wireless / radio
MTC public-network equipment homologation: Telecom terminal

4 maintained overlays

Open details →

D14

Fees

Verified

Registration (inscripción) - Class I medical device: PEN 1,438.70
Re-registration (reinscripción) - Class I medical device: PEN 1,405.40

11 maintained fee lines

Checked 2026-08-25

Open details →

D15

Review clocks

Verified

Class I · Notification: 22 working days
Class II · Registration: 44 working days
Class III · Registration: 66 working days

4 maintained pathways · 2 related facts

Checked 2026-08-30

Open details →

D16

Approval validity & renewal

Verified

Registration valid 5 years from grant: 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 cinc…
Reinscripción may be filed from one year before expiry: 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).

2 source-linked facts

Checked 2026-08-25

Open details →

Lifecycle & post-market

D17

Change control

Verified

Registration changes approved by risk impact: 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…
Domestic contract/staged laboratory name: Section 1.5 applies a domestic laboratory company name communication only in contract manufacturing or manufacturing by stages. The sheet requires the new company name and the number/date o…

6 source-linked facts

Checked 2026-10-26

Open details →

D18

UDI, listing & traceability

Verified

Single national identification standard and traceability duty: The ANM establishes and publishes a single product identification standard for pharmaceuticals, devices and sanitary products, mandatory nationwide; establishments that manufacture, import,…

1 source-linked fact

Checked 2026-08-25

Open details →

D19

Clinical investigation & performance

Verified

Clinical evaluation report for Classes III/IV: 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 per Declaration of Helsinki: 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 justifi…

3 source-linked facts

Checked 2026-08-25

Open details →

D20

Special access & derogation

Verified

Exceptional authorization cases for unregistered devices: 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 urgenc…
Visación de receta individual import route: Individual patients may import an unregistered device needed for their treatment through the 'Autorización Excepcional de Importación' with Visación de Receta, limited to prevention, indivi…

2 source-linked facts

Checked 2026-08-25

Open details →

D21

Manufacturer PMS

Verified

Periodic safety report schedule: 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 onwar…

1 source-linked fact

Checked 2026-08-25

Open details →

D22

Vigilance & incident reporting

Verified

Holder duty to report adverse events: 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 est…
Mild/moderate adverse incidents within 20 calendar days: 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.

3 source-linked facts

Checked 2026-08-25

Open details →

D23

Recall, FSCA & market surveillance

Verified

Field safety corrective action via Nota de Seguridad en Campo: 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 Se…

1 source-linked fact

Checked 2026-08-25

Open details →

D24

Advertising, claims & promotion

Verified

No direct-to-patient promotion in health establishments: 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 comp…
OTC device ads must carry warnings and precautions: 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 inf…

3 source-linked facts

Checked 2026-08-25

Open details →

D25

Submission communications & appeal

Verified

Appeal instances for device decisions: 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 fil…
Observations must be cured within 30 business days: 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 gr…

2 source-linked facts

Checked 2026-08-25

Open details →

Government fees

Full fee schedule (11 lines) →

DIGEMID / VUCE registration fees in PEN · reviewed 2026-08-25

Fee line	Amount	Provenance
Registration (inscripción) - Class I medical device	PEN 1,438.70	Verified
Re-registration (reinscripción) - Class I medical device	PEN 1,405.40	Verified
Registration - Class II medical device	PEN 1,593.20	Verified
Re-registration - Class II medical device	PEN 1,562.90	Verified

7 more fee lines on the full schedule · 11 of 11 rows source-verified

Registration timeline

Full registration timeline →

Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathway	Review clock	Planning total	Provenance
Class I(Notification) 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	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) CAN harmonization applies	44 working days	4-8 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) Technical file review required	66 working days	6-12 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) All device procedures carry negative administrative silence (no deemed approval on lapse) Clinical data may be required	66 working days	8-15 months	Verified

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(22 working days)
5Registration Approval(1-2 weeks)

Latest regulation news

All Peru regulation news →

Newest official DIGEMID headlines from the daily-refreshed feed — every row links directly to the authority publication.

Aug 25DIDIGEMIDDIGEMID Communiqué No. 012-2026: Requirements for Establishment Availability and Technical Director Presence

Peru Aug 19DIDIGEMIDDIGEMID Communiqué No. 011-2026 on Registration and Re-registration of Medical Devices

Peru Jul 5DIDIGEMIDDIGEMID Communication No. 009-2026: Clinical Evaluation Report of Medical Devices

Peru

Key regulations

All 14 Peru regulations →

Official DIGEMID rules and guidance · 14 of 14 documents linked to official sources

Formato de cambios de importancia menor — Versión1Cambios de importancia menor de los dispositivos médicos y dispositivos médicos de diagnóstico in vitro — Versión1

RegistrationVerified

Instructivo de detalle — Abril2013Registration model/code detail instructions — April2013 edition

RegistrationVerified

Instructivo de formato complementario — Versión3 (Julio2017)Registration detail form instructions — Version3, July2017

RegistrationVerified

DIGEMID medical-device FAQPreguntas Frecuentes — Disp. Médicos

RegistrationVerified