Medical Device Market Approval & Certification

Medical Device Certification

Enter global markets by complying with applicable medical device certification standards

Enter global markets by complying with applicable medical device certification standards

Ensure You Receive Approval for Your Medical Devices

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 equipment 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, read TÜV SÜD’s medical device market access guides via the links below.


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The New Medical Device Regulation (MDR)
Infographics

The New Medical Device Regulation

Extended transition period ends on May 26, 2024 for devices with valid MDD/AIMDD certification

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EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices
Report

EU Regulation 2017/746 on In Vitro Diagnostic Medical Devices

A quick guide to the new IVDR

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