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Device Registration

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to place devices on the market. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.

Depending on where you plan to sell your device(s), successful registration may involve substantial effort to meet premarket technical and clinical submission requirements or leveraging your existing registrations and approvals to gain faster access to new markets.

Medical device registration support across all major markets

With offices worldwide, Emergo has helped medical device and IVD companies register their products in over 55 markets. Our consultants provide device registration and regulatory compliance expertise in established markets such as the US, Europe and Japan as well as emerging markets including China, Brazil, India, and Mexico. We support medical device companies with their registration goals in the following markets:

Explore all device registration services.

Medical device and IVD market monitoring and registration tracking

Our consultants and project managers track regulatory changes in all markets where we operate, ensuring that your premarket application meets the most up-to-date requirements for US FDA 510(k) clearance, European CE Marking, Japanese PMDA approval and other market registrations. Using our Regulatory Affairs Management Suite (RAMS), our clients stay informed about relevant changes, avoid expirations, and manage registrations for their entire product line. Watch the video to explore the RAMS platform or visit the RAMS-Track website.


Questions? Request more information from our specialists


Meet Emergo at Hospitalar , May 21, 2019 to May 24, 2019 in São Paulo, Brazil


Device Registration

Australia | Device Registration

In Vitro Diagnostic (IVD) Registration in Australia

Australia | Device Registration

Medical Device Registration with the Australian TGA

Hong Kong | Device Registration

Medical Device Registration in Hong Kong

Malaysia | Device Registration

Medical Device Registration in Malaysia

New Zealand | Device Registration

MedSafe Medical Device Registration in New Zealand

Russia | Device Registration

Medical Device and IVD Registration in Russia

South Korea | Device Registration

Technical File Preparation for Korea MFDS Submissions

United States | Device Registration

US FDA 510(k) Consulting for Medical Devices and IVDs

Device Registration

MHRA Guidance on a No-Deal Brexit