Regulatory Prospective on Software as a Medical Device

  • Foram Chothani
  • Vinit Movaliya
  • Khushboo Vaghela
  • Maitreyi Zaveri
  • Shrikalp Deshpande
  • Niranjan Kanki


Software is becoming increasingly important in medical devices and digital adoption more broadly. It is becoming more important as a medical device in its own right. (1) Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control and clinical evaluation for SaMD. Millions of users use AI based medical device for the diagnosis & Management of diseases. Regulation for the SaMD, IMDRF published guidance document in 2013, in EU they are regulated by EMA, in Australia they are regulated by TGA and in Canada they are regulated by Health Canada. Regulations of these countries and IMDRF were reviewed and articles of challenges in artificial intelligence based medical devices reviewed. There are also many challenges like cybersecurity, safety, and decommissioning, high cost of device and also the design and development process. The objective is to focus on SaMD’s regulations and Challenges.

Keywords: SaMD, MDSW, Medical Device, IMDRF, TGA, MDR, Health Canada, Challenges


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How to Cite
Chothani, F., V. Movaliya, K. Vaghela, M. Zaveri, S. Deshpande, and N. Kanki. “Regulatory Prospective on Software As a Medical Device”. International Journal of Drug Regulatory Affairs, Vol. 10, no. 4, Dec. 2022, pp. 13-17, doi:10.22270/ijdra.v10i4.545.

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