DIGEMID market access

Peru medical device registration resources

Research DIGEMID registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Peru medical device resource.

33,109 registration records11 free resources24/25 topics with records5 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official DIGEMID device registration records.

Medical device registry insights

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Medical device regulations

Browse official DIGEMID regulations and guidance documents.

Registration timeline

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Government registration fees

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AI registration cost and timeline planner

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Medical device regulation news

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AI medical device classifier

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Additional certification and licence checker

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AI similar registered product finder

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Regulatory requirements data

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

Structured regulatory requirements

Explore all 52 source-linked facts →

24 of 25 research dimensions currently covered · 13 official sources · latest verification 2026-09-15

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…
Directorate that decides device registrations: Device registration decisions are formalized in a Resolución Directoral issued by the Dirección de Dispositivos Médicos y Productos Sanitarios of DIGEMID.

3 source-linked facts

Checked 2026-08-25

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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

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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

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D04

Classification rules

Verified

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

1 maintained scheme

Checked 2026-08-25

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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

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D06

Reliance & recognition

Verified

China NMPA approval: not reference: 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.…
China NMPA approval: origin evidence only: 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 orig…

4 source-linked facts

Checked 2026-09-15

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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

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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

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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…

4 source-linked facts

Checked 2026-08-25

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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

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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…

1 source-linked fact

Checked 2026-08-25

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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

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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

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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

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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

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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

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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…
Agotamiento de stock must be requested within 30 days: 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…

2 source-linked facts

Checked 2026-08-25

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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)	22 working days	2-4 months	Verified
Class II(Registration)	44 working days	4-8 months	Verified
Class III(Registration)	66 working days	6-12 months	Verified
Class IV(Full Registration)	66 working days	8-15 months	Verified