CARICOM (Caribbean Community) Product Registration & Certification
Important Notes
- Language Requirement Variations: Primarily English technical documents; Haiti requires French, Suriname requires Dutch translations based on target countries
- National Difference Management: Significant variations in registration requirements, processes, and timelines across member states requiring country-specific strategies
- Legal Representative System: Most countries require local authorized representative, distributor, or registration holder as legal responsible entity
- Registration Validity Periods: Registration certificates typically valid 3-5 years requiring renewal application 3-6 months in advance with possible requirement changes
- Simplified Procedure Utilization: Some countries accept simplified procedures based on origin country approval, WHO prequalification, or stringent regulatory authority approvals
- CARICOM Mutual Recognition Progress: Advancing pharmaceutical registration mutual recognition within CARICOM but progress slow; currently mainly independent national approvals
- Document Authentication Requirements: Technical documents typically require origin country notarization and embassy/consulate authentication; some countries require original documents
- Clinical Trial Considerations: Clinical trials in Caribbean region require national Ministry of Health and ethics committee approvals with varying requirements
CARICOM Specific Requirements
- Decentralized Independent Regulatory Systems: National Ministries of Health conduct independent approvals but reference CARPHA technical guidelines for coordination
- Multilingual Technical Documentation: Primarily English technical documents with special language requirements in Haiti (French), Suriname (Dutch)
- Wide International Standards Acceptance: Generally accepts international certifications (ISO, GMP, WHO prequalification) as product conformity evidence
- Significant Regional Variations: Registration processes and timelines vary greatly by country economic development and regulatory capacity requiring tailored planning
- Small Island Simplified Procedures: Small island developing states typically adopt simplified or trust-based registration procedures expediting market access
- Gradual Regional Harmonization: Advancing regulatory harmonization within region; CARICOM Regional Registration of Medicines (RRM) system under development
- Special Focus on Tropical Diseases: Particular attention to accessibility and quality assurance for malaria, dengue, and other tropical disease-related products
- Important Traditional Medicine Status: Traditional medicines and herbal products hold significant position in Caribbean with regulatory frameworks under improvement
Medical Devices Registration
Regulatory Requirements
- Medical Device Registration Certificate (issued by national MOH)
- Classification according to target country regulations (some reference CARPHA guidelines)
- Complete English technical documentation
- Quality Management System certificate (ISO 13485 preferred)
- Certificate of Free Sale (CFS) from country of origin
- Product performance and safety verification reports
- Labeling compliance certificate (English, some countries require bilingual)
- Biocompatibility assessment (for Class II and above devices)
Main Process
- Determine target country requirements
- Prepare English technical documentation
- Designate local authorized representative
- Submit registration application
- Coordinate technical review
Registration Timeline
4-12 months
Official Fees
$500 - $5,000
Service Fees
$8,000 - $25,000
Regulatory System Overview
National MOHs
National Ministries of Health (e.g., Jamaica MOH, Trinidad and Tobago MOH, Barbados MOH)
Independently responsible for medical devices, cosmetics, and pharmaceuticals registration, market surveillance, post-market safety monitoring, and compliance enforcement in respective countries
CARPHA
Caribbean Public Health Agency
Coordinates regional public health matters, develops technical guidelines, standards, and training, supports member states regulatory capacity building, but has no direct approval authority
Medical Devices Registration Process
Country Requirements Analysis
Analyze specific regulatory requirements of target countries (e.g., Jamaica, Trinidad and Tobago, Barbados)
Technical Documentation
Prepare complete English technical file including specifications, test reports, clinical evaluation
Local Representative
Designate authorized representative or distributor in target country (mandatory in most countries)
Registration Application
Submit registration application and all documents to relevant national Ministry of Health through local representative
Technical Review Coordination
Coordinate with regulatory authority technical review, provide additional information or clarifications
Cosmetics Registration
Regulatory Requirements
- Cosmetic Registration/Notification Certificate
- Ingredient safety assessment report (English)
- Complete Product Information File (PIF) in English
- Good Manufacturing Practice certificate (GMP)
- Product stability test reports
- Labeling compliance review
- Certificate of Free Sale from country of origin
- Declaration of compliance with prohibited substances
Main Process
- Assess ingredient compliance
- Prepare safety dossier
- Designate local representative
- Submit notification application
- Obtain market approval
Registration Timeline
2-6 months
Official Fees
$300 - $2,000
Service Fees
$5,000 - $15,000
Regulatory System Overview
National MOHs
National Ministries of Health (e.g., Jamaica MOH, Trinidad and Tobago MOH, Barbados MOH)
Independently responsible for medical devices, cosmetics, and pharmaceuticals registration, market surveillance, post-market safety monitoring, and compliance enforcement in respective countries
CARPHA
Caribbean Public Health Agency
Coordinates regional public health matters, develops technical guidelines, standards, and training, supports member states regulatory capacity building, but has no direct approval authority
Cosmetics Registration Process
Ingredient Compliance
Review cosmetic ingredients for compliance with target country regulations (referencing CARPHA guidelines)
Safety Dossier Preparation
Establish complete Product Information File including safety assessment report
Local Representative
Designate authorized representative or importer in target country
Notification Submission
Submit cosmetic notification or registration application to relevant country (process varies by country)
Labeling Compliance
Ensure English labeling meets country-specific requirements, some require bilingual labeling
Pharmaceuticals Registration
Regulatory Requirements
- Drug Registration Certificate (issued by national MOH)
- Complete Common Technical Document (CTD format)
- Quality, safety, and efficacy data
- Stability study reports
- Good Manufacturing Practice certification (GMP)
- Marketing approval proof from country of origin
- Summary of Product Characteristics (SmPC) and package leaflet
- Pharmacovigilance system description
Main Process
- Confirm registration category and requirements
- Prepare CTD registration dossier
- Designate local registration holder
- Submit registration application
- Coordinate technical review
Registration Timeline
8-24 months
Official Fees
$1,000 - $10,000
Service Fees
$15,000 - $50,000
Regulatory System Overview
National MOHs
National Ministries of Health (e.g., Jamaica MOH, Trinidad and Tobago MOH, Barbados MOH)
Independently responsible for medical devices, cosmetics, and pharmaceuticals registration, market surveillance, post-market safety monitoring, and compliance enforcement in respective countries
CARPHA
Caribbean Public Health Agency
Coordinates regional public health matters, develops technical guidelines, standards, and training, supports member states regulatory capacity building, but has no direct approval authority
Pharmaceuticals Registration Process
Registration Requirements
Clarify drug registration classification, requirements, and exemptions in target countries
CTD Dossier Preparation
Prepare complete registration dossier in CTD format (Modules 1-5)
Local Holder Designation
Designate registration holder or authorized representative in target country (mandatory)
Registration Submission
Submit drug registration application and technical data through local representative
Technical Review Follow-up
Follow technical review progress, promptly respond to regulatory queries and requirements