Global Regulatory Affairs
Regulatory Affairs remains a cornerstone in Suma Medtec’s portfolio of services. No matter the current regional focus of your product, we help prepare you to succeed while aiming for future growth.
Strategy
Starting with product risk classification and considerations for regional requirements, we build a success plan for each product.
Communication
Depending on the approach, early alignment with authorities may be the best form of project risk mitigation. We will help with each step.
Labeling
We can help you solve common challenges arising from region-specific requirements, even as they impact packaging design or manufacturing.
Documentation
We offer a new perspective to your Design History File documentation, identifying submission risks early in the process. Technical submission summaries are also a snap.
Submissions
Where to?
- FDA pathways
- EU
- UK
- LATAM
- Canada
- Australia
- ROW
EU Authorized Representative
Suma Medtec is your ticket to the European market. We assist medical device manufacturers with special regulatory requirements, including a physical presence in the EU, product registrations, incident reporting, and continued compliance with the latest directives. Simply put, we enable an expanded global reach so you can focus on product innovation.
Expertise and Compliance
Our team provides in-depth knowledge of European regulations and directives governing medical devices. We will guide you through the compliance process, assist in the development and verification of technical documentation, and ensure adherence to necessary conformity assessment procedures. Additionally, we provide regulatory support throughout the lifetime of your products.
Accessible
Records
As an authorized representative, we maintain secure records of your technical documentation, EU declaration of conformity, and relevant certificates. This facilitates efficient communication with Competent Authorities and streamlines regulatory inspections.
EUDAMED
Registration
We will assist you in registering your devices and obtaining a Single Registration Number (SRN) in the European Database on Medical Devices (EUDAMED). This registration is crucial for ensuring traceability, incident reporting, and compliance within the EU regulatory framework.
Incident Reporting and Support
Our team will handle incident reporting and communicate Field Safety Corrective Actions on your behalf. We will liaise with Competent Authorities, ensuring that any necessary notifications are made in a timely and compliant manner.
Labeling and Instructions for Use
Your products will bear the required information, including our contact details as the authorized representative. We will also work closely with you to ensure all literature and labeling is accurate and compliant to EU regulations.
To learn more about our EU Authorized Representative services, please contact us at eurep@suma-medtec.com.
