Choose another country to see content specific to your location

//Select Country

Medical Device Certification

Enter global markets by complying with applicable medical device certification standards

The global medical device market is governed by a broad range of national and international regulations and medical equipment certification standards

These regulatory requirements are complex and vary between regions, which can make it challenging to gain medical approval for your products in your target market.

TÜV SÜD has in-depth knowledge and experience of medical device certification standards around the globe and can provide advice and guidance to ensure you receive medical approval for your devices in key global markets.

For more information on medical device certification, read TÜV SÜD’s medical device market access guides via the links below.

 

RESOURCES TO HELP YOU LEARN MORE ABOUT MEDICAL DEVICE CERTIFICATION

IVDR Overview White Paper
White paper

IVDR Overview

Explore the In Vitro Diagnostic scope and definitions as well as the manufacturer requirements

Learn More

Reprocessing Validations for Reusable Medical Devices
Webinar

Reprocessing Validations for Reusable Medical Devices

Learn about sterilization requirements for reusable medical devices

Learn More

Decoding Article 117 of the EU MDR
Webinar

Decoding Article 117 of the EU MDR

Comply with MDR Article 117

Learn More

VIEW ALL RESOURCES

Next Steps

Select Your Location

Global

Americas

Asia

Europe

Middle East and Africa