Leverage our expertise to solve complex regulatory challenges. We will design a regulatory and QMS strategy that takes your product to established and emerging markets worldwide.
We utilize years of hands-on experience to help our customers get their products to market as efficiently as possible. We can compile, submit, and manage all your device registrations.
Thousands of device companies choose Emergo as their independent in-country representative to maintain control of their device registrations.
We provide post-market compliance solutions, incident reporting, and global vigilance support informed by a life-cycle approach to device safety and effectiveness.
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Get the latest industry insights from our Market Access experts.
Singapore HSA Finalizes Unique Device Identification (UDI) Requirements for Medical Devices
Singapore's health sciences authority (HSA) has issued final guidance on unique device identification (UDI) rules for medical devices and IVDs, with a phased implementation timeline for compliance. Learn more at Emergo by UL.
Chinese Regulators Revise Drug-Device Combination Product Registration Requirements
Chinese regulators have updated marketing application requirements for makers of combination products featuring pharmaceutical and medical device components. Learn more about NMPA regulations for combination products, medical devices and IVDs.
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