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Current Regulatory Landscape of Software as Medical Device in India: Framework for Way Forward | IEEE Conference Publication | IEEE Xplore

Current Regulatory Landscape of Software as Medical Device in India: Framework for Way Forward


Abstract:

Software as Medical Device (SaMD) is increasingly being adopted to significantly improve healthcare. Considering their growing importance in the country, a clear understa...Show More

Abstract:

Software as Medical Device (SaMD) is increasingly being adopted to significantly improve healthcare. Considering their growing importance in the country, a clear understanding of the regulatory framework is needed to address any challenges related to their implementation. The objective of this study is to compare regulatory guidelines of SaMD in India in comparison to USA, EU, and Australia. Secondary data analysis based on literature related to regulation policies has been carried out. The databases searched were PubMed, Google Scholar, Science Direct and JGATE. Though SaMD has been included in the recent Medical Devices Rules (MDR) 2020, there are still gaps in the regulatory guidelines. There is no clear distinction between standalone and combined SaMD. There is no separate consideration for artificial intelligence based SaMD. Also, there is no clearer mechanism for SaMD evaluation through alternate pathways. Based on our findings we have proposed a framework for adoption of SaMD in the country. In addition, it is recommended that a separate regulation body for SaMD be constituted considering the complexities of SaMD.
Date of Conference: 15-17 March 2023
Date Added to IEEE Xplore: 04 May 2023
ISBN Information:
Conference Location: New Delhi, India

References

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