Bolivia Product Registration Certification
Important Notes
- MoH & National Regulatory Agency Approval: All pharmaceuticals, medical devices, cosmetics, and health-related products require sanitary registration from UNSA/AGEMED and a registration number for marketing.
- Statutory Status of Traditional Herbal & Natural Products: Herbal products with Andean traditional use have a defined regulatory status, possibly with a distinct registration pathway requiring evidence of traditional safety.
- Mandatory Local Agent or Importer: Applications must be submitted by a locally registered Bolivian company, which becomes the registration holder and primary responsible party.
- Document Legalization & Bilingual Labeling: Registration documents require Bolivian consular legalization. Primary labels must be in Spanish, with inclusion of an indigenous language like Quechua or Aymara recommended.
- Dominance of Government Procurement & Price Registration: Public sector procurement is the main market channel. Products require price registration with the MoH, and participation in government tenders is critical for market share.
- Recognition of Neighboring Country Approvals & Int‘l References: UNSA/AGEMED may reference approvals from neighboring countries or WHO during review due to limited regulatory resources.
Bolivia Specific Requirements
- Diverse & Fragmented Andean Market: The market combines modern healthcare in major cities with traditional medicine demand in rural areas, resulting in vast disparities in purchasing power and channel structures.
- Public Procurement as the Lifeline for Market Access: Centralized procurement by the public health system dictates the market for most essential medicines and devices, making government relations and understanding tender cycles vital.
- Regulatory Enforcement Balances Formality & Flexibility: While the legal framework is established, practical enforcement can vary, requiring strong local adaptability and communication skills from companies.
- Distribution Challenges from Geography & Infrastructure: Mountainous terrain and underdeveloped transport networks impact supply chain efficiency, especially in rural areas, making logistics a key consideration.
- Regional Integration Potential as an Andean Community Member: As a CAN member, Bolivia’s regulations are influenced by regional harmonization efforts, but national sovereignty over approvals remains absolute.
Medical Devices Registration
Regulatory Requirements
- ANMM Health Registration (Registro Sanitario)
- Risk-based classification system (Class I-III)
- Technical documentation and test reports
- Spanish labeling and instructions for use
- Quality Management System compliance
- Andean Community Technical Regulations compliance
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing (where applicable)
- Electrical safety certification (where applicable)
Main Process
- Product classification determination
- Technical documentation preparation
- ANMM review submission
- Quality management system audit
- Registration certificate acquisition
Registration Timeline
8-16 months
Official Fees
BOB 3,000 - 18,000
Service Fees
$10,000 - $30,000
Regulatory System Overview
AGEMED
Bolivian National Agency for Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tecnologías en Salud)
National regulatory authority in Bolivia responsible for developing regulatory policies, registration approval, and quality supervision of pharmaceuticals, medical devices, cosmetics, and health products, with UNIMED unit handling specific registration implementation
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class I-III) according to ANMM and Andean Community guidelines
Technical Documentation Preparation
Prepare comprehensive technical documentation in Spanish including test reports and performance data
Local Representative Appointment
Designate Bolivian Authorized Representative as required by ANMM regulations
ANMM Application Submission
Submit Medical Device Health Registration application with all supporting documentation
Post-Market Surveillance
Establish vigilance system and adverse event reporting requirements
Cosmetic Products Registration
Regulatory Requirements
- ANMM Health Registration (Registro Sanitario)
- Ingredient formulation safety assessment
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Andean Community Technical Regulations compliance
- Product safety data and toxicological information
- Microbiological quality specifications
- Stability study documentation
- Manufacturing process description
- Quality control procedures
Main Process
- Ingredient formulation assessment
- Label review preparation
- ANMM registration submission
- GMP system establishment
- Technical documentation maintenance
Registration Timeline
4-8 months
Official Fees
BOB 800 - 4,000
Service Fees
$5,000 - $13,000
Regulatory System Overview
AGEMED
Bolivian National Agency for Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tecnologías en Salud)
National regulatory authority in Bolivia responsible for developing regulatory policies, registration approval, and quality supervision of pharmaceuticals, medical devices, cosmetics, and health products, with UNIMED unit handling specific registration implementation
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and regulatory compliance with ANMM and Andean Community requirements
Spanish Labeling Review
Prepare Spanish labeling compliant with ANMM cosmetic regulations
Health Registration Submission
Submit Cosmetic Health Registration application to ANMM
GMP System Implementation
Establish Good Manufacturing Practices quality system
Technical Documentation Maintenance
Maintain complete product technical file and compliance records
Health Supplements Registration
Regulatory Requirements
- ANMM Health Registration (Registro Sanitario)
- Ingredient safety and efficacy evidence
- Spanish labeling requirements compliance
- Good Manufacturing Practices compliance
- Scientific basis for health claims
- Stability study documentation
- Manufacturing process description
- Quality control specifications
- Ingredient specifications and testing
- Product formulation details
Main Process
- Product classification confirmation
- Technical documentation preparation
- ANMM registration submission
- Scientific review assessment
- Registration certificate acquisition
Registration Timeline
5-10 months
Official Fees
BOB 1,500 - 6,000
Service Fees
$7,000 - $18,000
Regulatory System Overview
AGEMED
Bolivian National Agency for Medicines and Health Technologies (Agencia Estatal de Medicamentos y Tecnologías en Salud)
National regulatory authority in Bolivia responsible for developing regulatory policies, registration approval, and quality supervision of pharmaceuticals, medical devices, cosmetics, and health products, with UNIMED unit handling specific registration implementation
Health Supplements Registration Process
Regulatory Classification
Confirm product classification as health supplement under Bolivian regulatory framework
Technical Documentation Preparation
Prepare ingredient analysis, safety evidence, and supporting documentation
Local Representative Appointment
Designate Bolivian Authorized Representative for regulatory submissions
ANMM Registration Submission
Submit Health Supplement Registration application to ANMM
Post-Market Compliance
Establish quality monitoring system and compliance framework