Simplifying Global Regulatory Challenges for SaMD products
To help you address the challenges that come with launching and maintaining Software as a Medical Device (SaMD) products on the market, IQVIA Regulatory Intelligence has expanded our SaMD cross-country table to cover five new countries: UK, Canada, Ireland, Singapore, and Australia, in addition to USA, EU, Japan, South Korea, and China.

With IQVIA Regulatory Intelligence SaMD cross-country table, access essential information necessary for launching and maintaining a SaMD product in the market including:

  • Identification of relevant regulatory authorities in each country
  • Definition and criteria for designation of SaMD
  • Pre- and post-market requirements to ensure compliance
  • All the pertinent coverage of regulations, guidance, and other regulatory documents

For more information, please read our fact sheet.
To speak to a member of our team or to see a demo, please fill in your details here to find out how IQVIA Regulatory Intelligence can support your regulatory compliance.
By selecting this box, I consent to receiving marketing communications and information about IQVIA's offering by email.

Copyright © 2026 IQVIA Holdings Inc. and its affiliates. All rights reserved. Privacy Statement

DO NOT SELL MY PERSONAL INFORMATION