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CDSCO Clarifies Regulatory Pathway for AI/Software Medical Devices Under MDR 2017

Target:UPSC GS-IIIMPSCSSC GATeachingPrelims HighMains MediumStatic GK Link
29 Jul 2026
~2 min
Source: The Hindu
Key Data:Medical Devices Rules (MDR), 2017Drugs and Cosmetics Act, 1940Classes A, B, C, D
Bodies:CDSCOIMDRF
Practice MCQs from today's news ▸
What This Article Covers

1.CDSCO guidance clarifies regulatory pathway for AI and software-based medical devices under MDR 2017.

2.Key distinction between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) aligned with IMDRF principles.

3.AI/ML diagnostic and clinical decision-support tools now have defined expectations on risk classification, clinical validation, and post-market surveillance.

The Big Picture
Prelims · HighMains · Medium

CDSCO has issued a guidance document clarifying how software-based and AI-enabled medical devices will be regulated under the Medical Devices Rules, 2017. This provides a clear compliance roadmap for innovators and manufacturers, distinguishing between Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), and introducing risk-based classification (Classes A-D).

Exam Lens

Quick Exam Facts From News

Regulatory BodyCentral Drugs Standard Control Organisation (CDSCO)
Governing ActDrugs and Cosmetics Act, 1940
Governing RulesMedical Devices Rules (MDR), 2017
Risk ClassificationClasses A, B, C, D
Key DistinctionSaMD vs SiMD (aligned with IMDRF)

1-Minute Revision

  • ›Regulatory Body: Central Drugs Standard Control Organisation (CDSCO)
  • ›Governing Act: Drugs and Cosmetics Act, 1940
  • ›Target this Data: CDSCO issued guidance on software-based medical devices under MDR 2017
  • ›Target this Nodal Body: Central Drugs Standard Control Organisation (CDSCO)
  • ›Target this Legal Point: Drugs and Cosmetics Act, 1940 and Medical Devices Rules (MDR), 2017

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Practice exam-style questions, track your score, and strengthen your recall.

Q1Static LinkageEasy

Which organization issued the guidance document clarifying the regulatory pathway for AI and software-based medical devices in India?

Q2Statement-basedHard

Consider the following statements regarding the CDSCO guidance on software-based medical devices:

1. The guidance introduces a new regulatory framework for software-based medical devices.

2. Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) are distinguished in the guidance.

3. The guidance applies to software intended for general wellness and fitness purposes.

Which of the statements given above is/are correct?

Q3Data-centricMedium

Under the CDSCO guidance, how many risk categories are software-based medical devices classified into?

Q4Application/ImpactMedium

What is the primary objective of the CDSCO guidance document on AI and software-based medical devices?

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