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Medical Device and IVD Registration in 20+ Countries Worldwide

Tap our expertise registering thousands of devices in established and emerging markets.

Medical device registration

Commercializing your medical device first requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. 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 20 countries. 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:

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. Explore the RAMS platform.

Related services to medical device registration

  • Health Canada IVD Registration and Approval
  • Health Canada CMDR Medical Device Registration and Approval
  • NMPA Medical Device Registration and Approval
  • Medical Device Registration and Approval in Colombia
  • Medical device registration and approval for Costa Rica
  • IVD Certification and Registration to Obtain CE Marking in Europe
  • India Medical Device Registration and Approval
  • Israel Medical Device Registration and Approval - AMAR
  • Foreign Manufacturer Registration in Japan
  • PMDA Medical Device Registration and Approval in Japan
  • Medical device registration and approval in Malaysia
  • COFEPRIS Medical Device and IVD Registration and Approval in Mexico
  • Mexico Registration Holder for Medical Devices
  • Medical device registration and approval in New Zealand
  • Medical device registration and approval for Peru
  • SFDA medical device registration in Saudi Arabia
  • Medical device registration and approval in Singapore
  • Medical device registration in Taiwan
  • US FDA Medical Device Establishment Registration