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Medical device software and AI: how India regulates them

By CAShorts DeskPublished Sources: CDSCO; Ministry of Health and Family Welfare Gazette notifications; PIB; ICMR; Akashvani News On AIR

Medical device software and AI: how India regulates them
Illustration (AI-generated)

India regulates software meant for a medical purpose as a medical device: a 2020 notification under the Drugs and Cosmetics Act, 1940 brought every device, software included, under the Medical Devices Rules, 2017. These Rules sort devices into four risk classes, A to D, that decide who licenses them. CDSCO's July 2026 guidance explains how software fits this scheme.

Syllabus: GS2 · Statutory & Regulatory Bodies; GS2 · Health, Education & Human Resources; GS3 · IT, Space, Biotech & IPR

Why this matters for UPSC

GS2 health governance and GS3 science and technology: Prelims can ask which authority licenses each risk class under the Medical Devices Rules, 2017; Mains, how India should regulate AI and software in healthcare.

In short

Medical device software is software its maker intends for a medical purpose; India regulates it as a drug under the Drugs and Cosmetics Act, 1940, through risk-based licensing.

From Act to licenceSection3(b)(iv)S.O. 648(E)MedicalDevicesRules, 2017Intended usedecidesState orCentralLicensing Authority

India's device law now reaches software; its test is keeping risk-based licensing quick enough for updating code without weakening patient safety.

Why it matters

A doctor using an app that reads an X-ray, or a patient checking a reading at home, relies on code that can be wrong. Treating such software as a device means its maker must prove safety and performance before selling it, and the regulator can cancel approval when it fails. Start-ups gain a clear route: they learn early whether a State office or the central regulator will judge them, and how much evidence the risk demands. Fitness trackers and wellness apps stay free of this burden. The larger issue is trust in digital health: as public platforms such as eSanjeevani add AI that advises clinicians, the rules decide who answers when a suggestion harms a patient.

Prelims pointers

  • The Drugs Controller General of India is the Central Licensing Authority for medical devices, by definition in Rule 3.
  • The 2017 device rules took effect on 1 January 2018, though notified in January 2017 as G.S.R. 78(E).
  • In vitro diagnostic devices are classified under Part II of the First Schedule; other devices under Part I.
  • Rule 7 requires devices to meet Bureau of Indian Standards norms, failing which ISO or IEC standards.
  • The National Accreditation Board for Certification Bodies under the Quality Council of India accredits Notified Bodies under the Medical Devices Rules, 2017.
  • The National Medical Devices Policy, 2023 came from the Ministry of Chemicals and Fertilizers, not the Ministry of Health and Family Welfare.
  • eSanjeevani, the National Telemedicine Service, was developed by the Centre for Development of Advanced Computing (C-DAC).

Practise a UPSC-style question

With reference to the Medical Devices Rules, 2017, consider the following statements:

1. The State Licensing Authority grants licences to manufacture Class C and Class D medical devices.

2. Medical devices other than in vitro diagnostics are placed in four classes, from low risk Class A to high risk Class D.

3. In vitro diagnostic medical devices are classified on parameters set out in a separate part of the First Schedule.

Which of the statements given above is/are correct?

  1. (a) 1 and 2 only
  2. (b) 2 and 3 only
  3. (c) 1 and 3 only
  4. (d) 1, 2 and 3
Show the answer

Answer: (b) 2 and 3 only

Answer: (b) 2 and 3 only. Rule 4 sets four risk classes and Rule 8 gives Class C and D manufacture to the Centre.

Statement 1: incorrect. Rule 8 makes the Central Licensing Authority responsible for manufacture of Class C and Class D devices; States handle Class A and B.

Statement 2: correct. Rule 4(1) grades devices as low, low moderate, moderate high and high risk, Class A to Class D.

Statement 3: correct. Rule 4(2) classifies in vitro diagnostic devices on Part II of the First Schedule; other devices use Part I.

Eliminate: Statement 1 swaps the licensing authority for the higher-risk classes. Out: (a), (c), (d).

Trap: Swapped attribution. The statement pins the higher-risk manufacturing licence on the State instead of the Centre.

Remember: A and B manufacture: State; C and D manufacture and all imports: Centre.

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