Republic of Peru Product Registration Certification
Important Notes
- DIGEMID & MINSA Centralized Regulation: Pharmaceuticals, medical devices, health supplements, and cosmetics are regulated by the Directorate General, requiring sanitary registration and listing.
- Clear Statutory Classification of Health Supplements: Peruvian regulations explicitly define vitamins, minerals, herbal extracts, etc., as Health Supplements, with a distinct registration pathway and specific requirements for claims and evidence.
- 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.
- Price Monitoring System & Free Pricing: The government monitors and may issue reference prices for drugs but does not directly control them. Health supplements and cosmetics are largely freely priced.
- Protection & Integration of Traditional Herbal Knowledge: Rich herbal traditions are recognized in regulations, with special provisions for products based on traditional use, promoting modernization and quality control.
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 health, beauty, and wellness products.
- Complementary Public & Private Healthcare Systems: The public social security system and a growing private insurance network drive the 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.
- High Consumer Acceptance of Natural & Traditional Products: Influenced by a rich herbal culture, consumers have a strong preference for natural ingredients, traditional formulas, and clean-label products.
- 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 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, pharmaceuticals, cosmetics, and health foods. Operates under Law No. 29459 (Pharmaceutical Law) and related regulations, responsible for product 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 product 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 & Certification
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
Cosmetics Registration
Regulatory Requirements
- DIGEMID Cosmetic Notification Certificate (Registration number starting with "RS")
- Ingredient formulation safety assessment (compliant with Peruvian Resolution No. 090-2005/MINSA)
- Spanish labeling compliant with NTP 334.086 requirements
- GMP compliance certificate (according to Peruvian Resolution No. 237-2002/MINSA)
- Compliance certificate for restricted and prohibited ingredients (according to Annex of Resolution No. 090-2005/MINSA)
- Product safety data sheet (SDS) and toxicological profile
- Microbiological quality specifications (according to Peruvian Pharmacopoeia standards)
- Accelerated stability study report (minimum 6 months data)
- Manufacturing process description and quality control procedures
- Manufacturer qualification documents
Main Process
- Ingredient formulation compliance review
- Prepare Spanish technical dossier
- Design regulatory compliant labels
- Appoint Peruvian Authorized Representative
- Submit notification through SISMED system
- Pay official notification fee
- Obtain notification confirmation document
Registration Timeline
General cosmetics: 2-4 months
Special function cosmetics: 3-6 months
Official Fees
Notification application fee: 500-1,500 PEN
Change notification fee: 200-800 PEN
Service Fees
Single product notification: $4,000-8,000
Product series notification: $8,000-15,000
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, pharmaceuticals, cosmetics, and health foods. Operates under Law No. 29459 (Pharmaceutical Law) and related regulations, responsible for product 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 product labeling authenticity review, advertising compliance supervision, consumer protection, and intellectual property (trademarks, patents) registration and protection.
Cosmetics Registration Process
Formula Compliance Assessment
Evaluate compliance of all ingredients according to Peruvian Resolution No. 090-2005/MINSA, ensure no prohibited substances, restricted substances within allowable limits
Technical Dossier Preparation
Compile complete Spanish technical dossier: formulation, manufacturing process, quality control, stability data, safety assessment
Label Design & Compliance
Design Spanish labels compliant with NTP 334.086 requirements, including ingredient list (INCI names), usage instructions, precautions, manufacturer information
Notification Submission
Submit cosmetic notification application through DIGEMID's SISMED electronic system, requires Peruvian Authorized Representative account
Review & Approval
DIGEMID conducts document review (typically 15-30 working days), issues notification certificate upon approval (no specific validity period but updates required)
Post-Market Maintenance
Establish product quality file, monitor market feedback, promptly report adverse events, formula changes require re-notification
Health Foods/Supplements Registration
Regulatory Requirements
- DIGEMID Health Food Registration Certificate (Registration number starting with "RS")
- Scientific evidence for ingredient safety and efficacy (according to Peruvian Resolution No. 094-2005/MINSA)
- Spanish labeling compliant with NTP 334.086 requirements
- GMP compliance certificate (according to Resolution No. 237-2002/MINSA)
- Scientific basis and literature support for health claims
- Accelerated stability study report (minimum 6 months data)
- Manufacturing process description and quality control specifications
- Raw material specifications, analytical methods and test reports
- Product formulation details and nutritional analysis
- Safety assessment and toxicological data
Main Process
- Product classification confirmation (regular food/health food)
- Prepare scientific evidence and technical documentation
- Appoint Peruvian Authorized Representative
- Submit DIGEMID registration application
- Undergo scientific review and evaluation
- Pay official registration fee
- Obtain registration certificate
Registration Timeline
Standard health foods: 4-8 months
New ingredients/new claims: 8-16 months
Official Fees
Registration application fee: 1,000-3,000 PEN
Registration certificate fee: 2,000-5,000 PEN
Renewal fee: 1,000-3,000 PEN/5 years
Service Fees
Basic products: $6,000-12,000
Products with new claims: $12,000-25,000
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, pharmaceuticals, cosmetics, and health foods. Operates under Law No. 29459 (Pharmaceutical Law) and related regulations, responsible for product 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 product labeling authenticity review, advertising compliance supervision, consumer protection, and intellectual property (trademarks, patents) registration and protection.
Health Foods/Supplements Registration Process
Product Classification & Definition
Confirm if product falls under health food category according to Peruvian Resolution No. 094-2005/MINSA, define permissible health claims
Scientific Evidence Collection
Collect scientific literature, clinical study data, ingredient safety data supporting health claims, prepare complete evidence dossier
Technical Documentation Compilation
Prepare Spanish technical documentation: formulation, manufacturing process, quality control, stability, safety, efficacy evidence
Registration Application Submission
Submit health food registration application to DIGEMID through authorized representative, all documents require notarization and legalization (where applicable)
Scientific Committee Review
DIGEMID scientific committee conducts review (typically 60-120 working days), may request additional data or clarification
Approval & Post-Market
Upon approval, obtain Health Food Registration Certificate (valid 5 years), establish post-market monitoring system, regularly update safety data