Republic of Peru Medical Device Registration
Important Notes
- DIGEMID & MINSA Centralized Regulation: All medical devices are regulated by the Directorate General, requiring sanitary registration and listing.
- Risk-Based Device Classification: Medical devices are classified into Class I-IV based on risk level, with differentiated registration pathways and technical documentation requirements.
- Local Authorized Holder System: A foreign manufacturer must appoint a locally registered Peruvian company as the Authorized Holder, responsible for all regulatory matters.
- Mandatory Spanish Documentation & Labeling: All technical dossiers, labels, and instructions must be in Spanish and comply with specific Peruvian technical standards (NTP 334.086).
- Clinical Evidence for Higher-Risk Devices: Class II-IV devices require clinical evaluation reports and performance data to demonstrate safety and efficacy.
- Quality System Compliance: Manufacturers must obtain ISO 13485 certification from a Peruvian accredited body or equivalent, as a prerequisite for registration.
Peru Specific Requirements
- One of the Most Dynamic & Growing Andean Markets: Political and economic stability, coupled with a growing middle class, drives rapid demand for quality medical devices and healthcare services.
- Complementary Public & Private Healthcare Systems: The public social security system and a growing private insurance network drive the medical device market, with complementary demands and purchasing power.
- Ongoing Regulatory Modernization & Efficiency Gains: DIGEMID actively promotes digital registration and process optimization, offering relatively good transparency and predictability in the region.
- Growing Demand for Innovative Medical Technologies: Healthcare providers increasingly seek advanced diagnostic, therapeutic, and monitoring devices to meet rising quality-of-care expectations.
- Strategic Gateway as a Pacific Alliance Member: Peru's stable economy and trade policies make it a key node for connecting to the South American Pacific coast medical device markets.
Medical Devices Registration
Regulatory Requirements
- DIGEMID Medical Device Registration Certificate (Registration number starting with "RS")
- Risk classification system (Class I-IV) according to Peruvian Ministry of Health Resolution No. 710-2011/MINSA
- Complete technical documentation (in Spanish): technical specifications, design verification, performance evaluation
- Spanish labeling and instructions for use compliant with Peruvian Standard NTP 334.086
- ISO 13485 Quality Management System certificate (certified by Peruvian accredited body)
- Biocompatibility test reports (according to ISO 10993 series standards)
- Certificate of Free Sale from country of origin (requires Peruvian consulate legalization)
- Clinical evaluation report and performance data (required for Class II-IV products)
- IEC 60601 series electrical safety certification (where applicable)
- EN ISO 14971 risk management documentation
- Manufacturer information file (QMS certificate, facility layout, etc.)
Main Process
- Product classification confirmation (Class I-IV)
- Appoint Peruvian Authorized Representative (legally mandatory)
- Prepare Spanish technical documentation
- Obtain Certificate of Free Sale and complete legalization
- Submit DIGEMID registration application
- Undergo technical documentation review
- Pay official registration fees
- Obtain registration certificate (valid for 5 years)
Registration Timeline
Class I: 6-8 months
Class II: 8-12 months
Class III-IV: 12-18 months
Official Fees
Application fee: 2,000-5,000 PEN
Registration fee: 3,000-8,000 PEN
Annual maintenance fee: 500-2,000 PEN/year
Service Fees
Class I: $10,000-15,000
Class II: $15,000-22,000
Class III-IV: $22,000-32,000
Regulatory System Overview
DIGEMID
General Directorate of Medicines, Supplies and Drugs (Dirección General de Medicamentos, Insumos y Drogas)
Under the Peruvian Ministry of Health, the primary regulatory authority for medical devices and pharmaceuticals. Operates under Law No. 29459 (Pharmaceutical Law) and related regulations, responsible for medical device registration, quality supervision, market surveillance, and compliance enforcement.
MINSA
Peruvian Ministry of Health (Ministerio de Salud del Perú)
The highest national health administrative authority, formulates public health policies, issues health regulations and technical standards, supervises operations of subordinate agencies including DIGEMID.
INDECOPI
National Institute for Defense of Competition and Protection of Intellectual Property (Instituto Nacional de Defensa de la Competencia y de la Protección de la Propiedad Intelectual)
Responsible for medical device labeling authenticity review, advertising compliance supervision, consumer protection, and intellectual property (trademarks, patents) registration and protection.
Medical Devices Registration Process
Regulatory Classification & Strategy
Determine medical device risk classification (Class I-IV) according to Peruvian Ministry of Health Resolution No. 710-2011/MINSA and develop registration strategy
Technical Documentation Localization
Prepare complete Spanish technical documentation including test reports compliant with Peruvian standards, performance data, and risk assessment documents
Appoint Local Legal Representative
Appoint Peruvian Authorized Representative according to DIGEMID Resolution No. 091-2008/DIGEMID, responsible for legal compliance and communication with regulatory authorities
Document Legalization & Submission
Complete consular legalization of Certificate of Free Sale, submit complete registration application through DIGEMID electronic system (SISMED)
Technical Review
DIGEMID conducts technical review (typically 60-90 working days), issues Medical Device Registration Certificate upon approval (valid for 5 years)
Post-Market Surveillance
Establish adverse event monitoring system, submit periodic safety update reports, complete registration renewal every 5 years