Mexican Medical Device Import Permit Application - COFEPRIS

Streamline Your COFEPRIS Medical Device Import Applications

Navigating Mexico's regulatory landscape for medical device imports requires precision, compliance, and detailed documentation. This Mexican Medical Device Import Permit Application form is designed specifically for medical device manufacturers, distributors, and import specialists who need to submit COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) applications efficiently and accurately.

Whether you're importing diagnostic equipment, surgical instruments, implantable devices, or in-vitro diagnostic products into Mexico, this template captures all the essential information COFEPRIS requires—from RFC and establishment registration details to technical specifications, quality certifications, and intended clinical use documentation.

Built for the medical device industry, this form template helps you collect structured data on product classification, risk categories, manufacturer information, Mexican regulatory agent details, and supporting documentation. The conditional logic ensures that only relevant fields appear based on device type and classification, making the application process smoother for both your team and regulatory reviewers.

With Paperform's document upload capabilities and calculation fields, you can attach required certificates (ISO 13485, CE marking, FDA clearance), product labels, instructions for use, and clinical evaluation reports—all in one organized submission. For businesses managing multiple import applications, Stepper workflows can automatically route submissions to regulatory consultants, quality assurance teams, and COFEPRIS liaisons, keeping your import pipeline moving without manual handoffs.

This template is trusted by pharmaceutical companies, medical equipment distributors, healthcare technology importers, and regulatory consultants across Mexico who need a professional, compliant starting point for COFEPRIS applications. Start with this template and customize it to match your specific product categories and internal approval workflows.