Software as a Medical Device

About the Book

Software healthcare ko fundamentally transform kar raha hai — AI-based diagnostics, remote patient monitoring, cloud-based clinical platforms aur data-driven decision support systems ab patient care ka integral hissa ban chuke hain. Jaise-jaise software ka role critical hota ja raha hai, waise-waise patient safety, regulatory compliance, data protection aur legal accountability bhi equally important ho gaye hain.

Medical Devices Rules (MDR), 2017 ke under India ne software ko bhi medical device ke definition mein include kiya hai. Isse manufacturers, software developers aur importers ke liye ek naya aur complex regulatory landscape create hua hai.

Software as a Medical Device: The Regulatory Pathway for Manufacturers & Importers ek India-focused, practical guide hai jo SaMD ke poore regulatory aur legal framework ko simple language mein explain karti hai—from classification to licensing, clinical evidence, cybersecurity, liability aur post-market compliance.

What this book covers

• SaMD applicability under MDR 2017: medical purpose vs wellness/lifestyle apps

• SaMD vs SiMD: regulatory difference + licensing impact

• Risk-based classification (A–D): seriousness of condition + clinical decision impact ke basis par

• Licensing pathways (India):

  • Manufacturing: MD-5 (Class A/B), MD-9 (Class C/D)

  • Import: MD-14 (application), MD-15 (import licence)

  • Loan licence: MD-6 / MD-10

  • Test/evaluation: MD-12 / MD-13 (clinical validation & performance studies)

• Essential Principles & Conformity Assessment: Fourth Schedule compliance

• QMS requirements: Fifth Schedule aligned with ISO 13485

• Software standards: IEC 62304 (lifecycle), ISO 14971 (risk), IEC 82304-1 (health software safety)

• Clinical investigation & performance evaluation: predicate ho to bridging/literature, novel software ho to clinical investigation requirements

• Legal & compliance: manufacturer vs developer liability, recall obligations, consumer/product liability, import compliance

• Data protection & cybersecurity: MDR essential principles + DPDP Act 2023 alignment, breach risk & legal exposure

• Post-market obligations: PMS, adverse event reporting timelines, licence suspension/cancellation, recall triggers

• Policy gaps & way forward: AI/ML updates, cloud-hosted SaMD jurisdiction, SaMD-specific guidance recommendations

Who should read this

• Medical device companies & digital health startups

• Software developers building medical-purpose apps/AI tools

• Importers & Indian Authorized Representatives

• Regulatory affairs, QA/QMS, compliance & legal teams

• Hospitals/healthcare networks evaluating SaMD procurement risks

Why this book is useful

Agar aap India mein SaMD launch ya scale karna chahte hain, toh yeh guide aapko licensing mistakes, classification confusion, cybersecurity/data-compliance risks, aur post-market penalties se bachate hue ek clear pathway deti hai—so you can confidently achieve market access + regulatory compliance + patient safety.

Authors: Rajul Jain & Shruti Jain (Founders – ELT Corporate Pvt. Ltd.)
Focus: SaMD Regulatory + Legal Compliance (India, MDR 2017)