Finnish Medical Device Registration Form

Finnish Medical Device Registration Form Template

Registering medical devices in Finland requires careful compliance with Fimea (Finnish Medicines Agency) regulations and EU Medical Device Regulations. This Finnish Medical Device Registration Form streamlines the entire process, helping manufacturers, authorized representatives, and importers submit complete device information while meeting all regulatory requirements.

Built for Finnish regulatory compliance

This template is specifically designed for businesses registering medical devices with Fimea, covering everything from CE marking verification to device classification and manufacturer details. The form captures all mandatory information including Business ID (Y-tunnus), device identification details, classification according to MDR/IVDR, and documentation of conformity assessment procedures.

Whether you're a medical device manufacturer, authorized representative, or importer operating in Finland, this form ensures you collect all required data points in the correct format—reducing back-and-forth with regulatory authorities and speeding up your time to market.

Paperform makes regulatory compliance straightforward

Instead of juggling PDFs, email chains, and manual data entry, Paperform lets you create a single, branded registration form that guides applicants through every required field with conditional logic. Show relevant questions based on device classification, automatically calculate fees, and use file upload fields to collect supporting documentation like certificates of conformity, technical files, and instructions for use.

Your submissions sync directly into your preferred systems—whether that's a CRM, project management tool, or internal database—so your regulatory affairs team can track applications, follow up on missing information, and maintain audit trails without switching platforms.

Automate post-submission workflows with Stepper

Once a device registration is submitted, there's still plenty of work to be done. Use Stepper to automate your regulatory workflow: route submissions to the right team members for technical review, send follow-up emails requesting additional documentation, update compliance tracking spreadsheets, and create tasks in your project management system—all triggered automatically from form submissions.

With Stepper's AI-native workflow builder, you can build sophisticated approval chains and notification sequences without writing code, ensuring nothing falls through the cracks during the registration process.

Secure, compliant, and ready for professional use

Paperform is SOC 2 Type II certified and GDPR compliant, giving you the security foundation that regulatory work demands. Set up conditional logic to show different fields based on device risk classification, use calculations to determine registration fees, and customize confirmation emails with next steps specific to each submission type.

Whether you're handling a handful of device registrations per year or managing a portfolio of medical devices across multiple manufacturers, this template gives you a professional, efficient starting point that respects both Finnish regulatory requirements and your applicants' time.

Trusted by healthcare organizations, medical device companies, and regulatory consultants worldwide, Paperform transforms complex compliance processes into streamlined digital experiences.