Mexico Product Registration & Certification
Important Notes
- All technical documentation, labeling, and instructions must be in Spanish
- Medical devices and herbal products must obtain health registration certificate for market distribution
- Cosmetics require health notification procedure
- Must appoint authorized representative in Mexico responsible for registration affairs
- Health registration certificates are typically valid for 5 years and require periodic renewal
- Products must comply with Mexican Official Standards (NOM) requirements
- Post-market surveillance and adverse event reporting systems must be established after registration
Mexico specific Requirements
- Mexico implements strict Spanish language labeling and documentation system
- All technical documentation must be in Spanish with certified translation
- Medical devices follow I-III risk classification system
- Herbal products have specific regulatory framework and requirements
- Must conduct registration applications through authorized representatives in Mexico
- Emphasis on quality requirements compliant with Mexican Official Standards (NOM)
- COFEPRIS regulatory system is strict with relatively complex processes
Medical Devices Registration
Regulatory Requirements
- Medical Device Health Registration (Registro Sanitario)
- Classification Management by Risk Level (Class I, II, III)
- Complete Spanish Technical Documentation
- Quality Management System Certificate (NOM-241-SSA1-2012)
- Free Sale Certificate and Certificate of Origin
- Product Performance Test Reports
- Biocompatibility Test Reports (if applicable)
- Clinical Data (Class III devices)
- Electrical Safety Certification (if applicable)
Main Process
- Product Classification Determination
- Technical Documentation Preparation
- Local Representative Appointment
- COFEPRIS Application Submission
- Technical Review
- Health Registration Certificate Acquisition
Registration Timeline
8-18 months
Official Fees
$2,000 - $10,000
Service Fees
$12,000 - $35,000
Regulatory System Overview
COFEPRIS
Federal Commission for the Protection against Sanitary Risks
Comprehensively responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, herbal products, and pharmaceuticals. Operates as the supreme health regulatory authority under the Mexican Ministry of Health.
Dirección de Medicamentos
General Directorate of Medicines and Medical Devices
Responsible for specific registration approval, technical evaluation, and post-market surveillance of medical devices and pharmaceuticals
SAT
Mexican Tax Administration Service
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Medical Devices Registration Process
Product Classification Determination
Determine product risk classification according to Mexico medical device regulations (Class I-III)
Technical Documentation Preparation
Prepare complete Spanish technical documentation including product specifications, test reports, quality system certificates
Local Representative Appointment
Appoint authorized representative in Mexico responsible for registration and regulatory affairs
COFEPRIS Application
Submit medical device health registration application to COFEPRIS
Technical Review
Pass COFEPRIS technical documentation review and conformity assessment
Cosmetics Registration
Regulatory Requirements
- Cosmetic Health Notification (Aviso Sanitario)
- Ingredient Safety Assessment Report (Spanish)
- Spanish Product Labeling
- Good Manufacturing Practice Certification (NOM-141-SSA1/SCFI-2012)
- Product Information File
- Stability Study Report
- Microbiological Test Reports
- Prohibited and Restricted Ingredients Compliance Proof
Main Process
- Ingredient Compliance Assessment
- Safety Assessment Completion
- Local Representative Appointment
- Health Notification Application
- Labeling Compliance Review
Registration Timeline
4-8 months
Official Fees
$800 - $3,000
Service Fees
$6,000 - $18,000
Regulatory System Overview
COFEPRIS
Federal Commission for the Protection against Sanitary Risks
Comprehensively responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, herbal products, and pharmaceuticals. Operates as the supreme health regulatory authority under the Mexican Ministry of Health.
Dirección de Medicamentos
General Directorate of Medicines and Medical Devices
Responsible for specific registration approval, technical evaluation, and post-market surveillance of medical devices and pharmaceuticals
SAT
Mexican Tax Administration Service
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Cosmetics Registration Process
Ingredient Compliance Assessment
Verify all ingredients comply with Mexico cosmetic regulations permitted and restricted lists
Safety Assessment Report
Prepare Spanish product safety assessment report signed by qualified safety assessor
Local Representative Appointment
Appoint authorized representative in Mexico responsible for registration affairs
Health Notification Application
Submit cosmetic health notification application and related technical documents to COFEPRIS
Labeling Compliance Review
Ensure product labeling fully complies with Mexico cosmetic labeling regulations
Herbal Products Registration
Regulatory Requirements
- Herbal Product Health Registration Certificate
- Traditional Use Evidence or Safety-Efficacy Data
- Quality Control Specifications (NOM-072-SSA1-2012)
- Spanish Labeling and Instructions
- Good Manufacturing Practice Certification
- Ingredient Specifications and Purity Proof
- Stability Study Data
- Pharmacopoeia Compliance Proof
Main Process
- Product Classification Confirmation
- Registration Dossier Preparation
- Local Representative Appointment
- Health Registration Application
- Technical Review Coordination
Registration Timeline
6-12 months
Official Fees
$1,200 - $5,000
Service Fees
$10,000 - $28,000
Regulatory System Overview
COFEPRIS
Federal Commission for the Protection against Sanitary Risks
Comprehensively responsible for registration approval, quality supervision, post-market safety monitoring, and market regulation of medical devices, cosmetics, herbal products, and pharmaceuticals. Operates as the supreme health regulatory authority under the Mexican Ministry of Health.
Dirección de Medicamentos
General Directorate of Medicines and Medical Devices
Responsible for specific registration approval, technical evaluation, and post-market surveillance of medical devices and pharmaceuticals
SAT
Mexican Tax Administration Service
Responsible for customs clearance, tax collection, and trade compliance regulation of imported products
Herbal Products Registration Process
Product Classification Confirmation
Confirm product falls under herbal product regulatory category, determine registration classification
Registration Dossier Preparation
Prepare complete Spanish technical documentation including traditional use evidence or safety data
Local Representative Appointment
Appoint authorized representative in Mexico with appropriate qualifications
Health Registration Application
Submit herbal product health registration application to COFEPRIS
Quality Control Establishment
Establish quality control standards and specifications compliant with Mexican standards