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Peru Medical Device Registration

Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) approval timelines and requirements

2-4 months
Typical Timeline
4
Device Classes
No
MDSAP Accepted
Required
Peru Registration Holder

Peru Medical Device Registration Overview

Peru medical device registration through DIGEMID typically takes 2-4 months for Class I devices. The official DIGEMID target is 1-2 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Peru uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Peru Registration Holder to register devices in Peru. Registration is valid for 5 years.

Registration Timeline by Device Class

Peru uses a 4-class (I, II, III, IV) risk-based classification system.

Class I

Notification

Low Risk
Official
1-2 months
Realistic
2-4 months

• Simplified notification process

Class II

Registration

Medium Risk
Official
3-6 months
Realistic
4-8 months
With Prior Approval
3-5 months

Accelerated with: FDA 510(k), EU CE Mark, ANVISA

• CAN harmonization applies

GMP/QMS Required

Class III

Registration

High Risk
Official
4-8 months
Realistic
6-12 months
With Prior Approval
4-7 months

Accelerated with: FDA 510(k)/PMA, EU CE Mark, ANVISA

• Technical file review required

GMP/QMS Required

Class IV

Full Registration

Highest Risk
Official
6-10 months
Realistic
8-15 months
With Prior Approval
5-8 months

Accelerated with: FDA PMA, EU CE Mark Class III

• Clinical data may be required

Clinical Trial RequiredGMP/QMS Required
Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Peru registration.

FDA 510(k)
Recognized for expedited review
2-3 months
EU CE Mark
Recognized for documentation
2-3 months
ANVISA (Brazil)
CAN harmonization
2-3 months
Key Requirements
  • Peru Registration Holder (for foreign manufacturers)
  • Spanish labeling and IFU
  • Free Sale Certificate
  • GMP certificate
  • Technical documentation
Registration Validity:

5 years

Registration Process Flowchart

Peru Medical Device Registration Process

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

Step 1: Pre-Submission Preparation

1-3 months

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

Step 2: Application Submission

1-2 weeks

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

Step 3: Administrative Review

2-4 weeks

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

Step 4: Technical Evaluation

1-2 months

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

Step 5: Registration Approval

1-2 weeks

Upon successful review, DIGEMID issues Peru market authorization certificate.

Summary: The Peru medical device registration process through Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
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🇺🇸 United StatesFDA🇪🇺 European UnionEU MDR🇨🇳 ChinaNMPA🇯🇵 JapanPMDA🇧🇷 BrazilANVISA🇨🇦 CanadaHealth Canada
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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.