##  [Regulatory Framework of Software as a Medical Device (SaMD)](/index%2Ephp/white-papers/regulatory-framework-of-software-as-a-medical-device-samd) 

- [Medical Devices](/index%2Ephp/white-papers-categories/medical-devices)
- [Digital Health](/index%2Ephp/white-papers-categories/digital-health)





 ![Regulatory Framework of Software as a Medical Device (SaMD)]()

SaMD plays a critical role in modern healthcare, and understanding its regulatory landscape is essential for developers, healthcare professionals, and regulatory authorities. This whitepaper aims to provide an overview of the regulatory framework governing Software as a Medical Device (SaMD). It sheds light on SaMD classification, regulatory submission, and the approval/clearance process in the USA, European Union, Canada, and Australia.



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