Enter global markets by complying with applicable medical device 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.
Explore the In Vitro Diagnostic scope and definitions as well as the manufacturer requirements
Learn about sterilization requirements for reusable medical devices
Comply with MDR Article 117
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