Chile Product Registration Certification
Important Notes
- ISP Mandatory Sanitary Registration: All pharmaceuticals, medical devices, cosmetics, and foods must be registered with the Institute of Public Health to obtain a registration number before import and sale.
- Clear Definition & Strict Claim Management for Dietary Supplements: These products are clearly defined and regulated. Health claims require pre-approval by ISP based on scientific evidence; unauthorized therapeutic claims are prohibited.
- Local Legal Representative Requirement: A foreign manufacturer must appoint a natural or legal person domiciled in Chile as its Legal Representative, responsible for registration, technical communication, and legal liability.
- Spanish Documentation & Compliance with Chilean Pharmacopoeia: All technical dossiers and labels must be in Spanish, and product standards must comply with the Chilean Pharmacopoeia or ISP-accepted alternatives.
- Liberalized Pricing & Private Market Dominance: Drug and device prices are market-driven. A robust private healthcare system and insurance drive demand for premium and innovative products.
- Broad Acceptance of International High-Standard Certifications: ISP highly recognizes approvals from SRAs in its reviews, which can streamline the technical assessment process.
Chile Specific Requirements
- Benchmark for Regulatory & Commercial Environment in Latin America: Possesses one of the region’s most stable, transparent, and efficient regulatory systems, with a well-ordered market and strong IP protection, making it the preferred test market.
- Highly Developed Private Healthcare & Insurance System: Over 80% of the population has private health insurance, fueling a mature, high-end market with strong willingness to pay for innovation and quality.
- Educated Consumers with Stringent Quality Demands: Chilean consumers are well-informed, valuing brand reputation, scientific substantiation, and product origin. Marketing must focus on professional education and evidence.
- Strategic Position as a Key Pacific Alliance Member: Chile’s stable economy and open trade policies make it a strategic hub for companies targeting the South American Pacific coast.
- Strong Regulatory Science & Process Predictability: ISP’s review is science-based with relatively transparent and predictable timelines, reducing uncertainty in market access.
Medical Devices Registration
Regulatory Requirements
- ISP Registration Certification (Registro ISP)
- Classification Management by Risk Level (Class I-IV)
- Technical Documentation and Test Reports
- Spanish Labeling and Instructions for Use
- Quality Management System Compliance
- Biocompatibility Testing (if applicable)
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- ISP Review Submission
- Quality Management System Audit
- Registration Certificate Acquisition
Registration Timeline
6-12 months
Official Fees
CLP 500,000 - 2,000,000
Service Fees
$10,000 - $25,000
Regulatory System Overview
ISP
Chilean Public Health Institute (Instituto de Salud Pública de Chile)
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, health products, and pharmaceuticals. Operates as the primary regulatory authority under the Chilean Ministry of Health.
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification (Class I-IV)
Technical Documentation Preparation
Prepare Spanish technical documentation and test reports
Local Representative Appointment
Appoint Chilean Authorized Representative
ISP Application Submission
Submit medical device registration application
Post-Market Surveillance
Establish adverse event monitoring system
Cosmetics Registration
Regulatory Requirements
- Cosmetic Notification and Registration
- Ingredient Formula Safety Assessment
- Spanish Labeling Requirements
- Good Manufacturing Practice Compliance
- Ingredient Restrictions Compliance
Main Process
- Ingredient Formula Assessment
- Labeling Review Preparation
- ISP Registration Submission
- GMP System Establishment
- Technical Documentation Maintenance
Registration Timeline
2-4 months
Official Fees
CLP 100,000 - 500,000
Service Fees
$4,000 - $10,000
Regulatory System Overview
ISP
Chilean Public Health Institute (Instituto de Salud Pública de Chile)
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, health products, and pharmaceuticals. Operates as the primary regulatory authority under the Chilean Ministry of Health.
Cosmetics Registration Process
Ingredient Formula Assessment
Evaluate cosmetic ingredient safety and compliance
Spanish Labeling Review
Prepare Spanish labeling compliant with ISP requirements
ISP Registration Submission
Submit cosmetic registration application
GMP System Establishment
Establish Good Manufacturing Practice system
Technical Documentation Maintenance
Maintain complete product technical files
Health Products Registration
Regulatory Requirements
- ISP Registration Approval
- Ingredient Safety and Efficacy Evidence
- Spanish Labeling Requirements
- Good Manufacturing Practice Compliance
- Scientific Basis for Health Claims
Main Process
- Product Classification Confirmation
- Technical Documentation Preparation
- ISP Registration Submission
- Scientific Review Assessment
- Registration Certificate Acquisition
Registration Timeline
4-8 months
Official Fees
CLP 300,000 - 1,500,000
Service Fees
$6,000 - $15,000
Regulatory System Overview
ISP
Chilean Public Health Institute (Instituto de Salud Pública de Chile)
Responsible for registration approval, quality supervision, and market regulation of health products including medical devices, cosmetics, health products, and pharmaceuticals. Operates as the primary regulatory authority under the Chilean Ministry of Health.
Health Products Registration Process
Product Classification Confirmation
Determine if product falls under health products category
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and other documents
Local Representative Appointment
Appoint Chilean Authorized Representative
ISP Registration Submission
Submit health product registration application
Post-Market Surveillance
Establish quality monitoring system