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.