Mexico is the import hub for Medical Devices in Latin America. The Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) is in-charge of monitoring medical device quality and safety, and also responsible to enforce import regulations for foreign manufacturers. The COFEPRIS classifies devices into Class I, II and III based on 20 rules framed by Health Products Technical Committee. Devices imported from US and Canada benefit from free-trade agreement, but manufacturers from other countries are subjected to thorough scrutiny. The rules intended for Medical Device regulation in Mexico are very broad needing extensive understanding. The basis for classification is ambiguous to decode. Challenges pertaining to linguistic translations are also prevalent.
Freyr provides Regulatory services for Device Classification in Mexico. Freyr aids in maintaining compliance for certifications and approval apart from offering expert linguistic services to understand the regulations and to translate documents.
Mexico Market Entry for Medical Devices - Process Flow
- Regulatory Assistance in Registration Process
- Medical Device Classification
- Authorized Local Registration Holder
- Regulatory Support in Procuring Good Manufacturing Practices (GMP) Certificates
- Dossier/Document Compilation
- Post-Market Surveillance
- Regulatory Liaison with local Health Authority