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India's Medical Device Rules

In India, rehabilitation robots and exoskeletons sold for medical use fall under the Medical Devices Rules, 2017, which CDSCO administers. This guide explains the four risk classes, who grants licences, and what to check before a device reaches your clinic.

By Aarav Mehta · Updated October 2026

Which law governs medical robots in India

CDSCO's medical device division states that all medical devices in India are regulated under the Drugs & Cosmetics Act, 1940 and the Medical Devices Rules, 2017 made under it. For a hospital or clinic, a powered therapy system is therefore a medical device first and a piece of robotics second. The Central Drugs Standard Control Organisation handles central functions such as import licences, permission for clinical investigations, test licences and approval of devices that have no predicate on the Indian market. It also keeps the Rules and their amendments together on one page, including a 2022 amendment on registering premises that sell medical devices and a 2021 amendment on unique device identification. Work from that current text rather than an older summary, because the Rules have changed several times since 2017.

Four risk classes from A to D

The Rules sort devices by risk into Class A (low), Class B (low to moderate), Class C (moderate to high) and Class D (high), as CDSCO's division page sets out. CDSCO then publishes lists that give named device types a class. Its rehabilitation list, File No. 29/Misc./03/2020-DC (160), places the powered lower extremity exoskeleton in Class B, alongside a motor-powered microprocessor knee and an upper extremity prosthesis with a powered elbow or shoulder. The same list puts a gait analysis system and a powered treadmill in Class A. When a maker tells you which class its product falls in, ask which list and entry it relied on, because a robot that combines several functions may not match any single entry neatly.

Who licenses manufacture and import

Responsibility splits by class. According to CDSCO, notified bodies accredited by the National Accreditation Body register with it to audit makers of Class A and Class B devices, while applications to manufacture Class C or Class D devices go to CDSCO on forms MD-7 and MD-8. Import licences are also granted through CDSCO. For a powered exoskeleton built abroad, ask who holds the Indian import licence, request the licence number and check that the exact model you are buying is covered. The Rules page also records a 2022 amendment exempting certain non-sterile Class A devices from licensing, which is one reason a simple accessory and a complex robot can reach the market by very different routes.

Paperwork to request before you sign

Ask the supplier for its import or manufacturing licence, the class it has assigned and the classification list entry behind that class. Confirm that the software version installed on your unit is the one the paperwork covers, since an update that changes the intended use can raise fresh regulatory questions. If the system is new to India, ask whether it needed permission as a device without a predicate, or whether it has only been used under a test licence for clinical investigation; a trial unit is not a product you can deploy routinely. Ask too whether the device carries a unique device identifier under the 2021 amendment, which makes recalls and complaints easier to trace. File every answer with the maker's instructions for use.

Sources and further reading

Medical Devices Rules, 2017 (text and amendments) — Central Drugs Standard Control Organisation (CDSCO).
CDSCO page holding the Medical Devices Rules, 2017 and later amendments, such as UDI and sales registration.
Medical Device & Diagnostics division — Central Drugs Standard Control Organisation (CDSCO).
CDSCO overview of device regulation in India: classes A to D, notified bodies, licences and classification lists.
Classification of Medical Devices pertaining to Rehabilitation, File No. 29/Misc./03/2020-DC (160) — Central Drugs Standard Control Organisation (CDSCO).
CDSCO risk-class list for rehabilitation devices, placing the powered lower extremity exoskeleton in Class B.

Common questions

Is a rehabilitation exoskeleton a medical device in India?

Yes, when it is intended for therapy or to support paralysed or weakened limbs. CDSCO's classification list for rehabilitation devices names the powered lower extremity exoskeleton as a Class B device, so the Medical Devices Rules, 2017 govern how it is imported, made and sold.

How do I check which CDSCO class a device is in?

Start with the risk classification lists CDSCO publishes by speciality, such as its rehabilitation list, and compare the device's intended use with each entry. Then ask the importer or maker to confirm the class in writing and to show the licence that covers that model.

Rehabilitation Exoskeletons — Powered exoskeletons and orthoses for gait rehabilitation and personal mobility.
Arm & Hand Therapy — Robotic and sensor-based systems for upper-limb therapy, from shoulder to fingertip.
Physical Therapy — Balance trainers, shoulder therapy systems and microprocessor knees for physiotherapy teams.
Gait & Mobility — Robotic gait trainers, wearable motion assist and patient-transfer robots.
Hospital & Care Robots — Hospital delivery robots, telepresence for remote consultations and companions for older adults.
Surgical Robots — How robot-assisted surgical systems work, and how hospitals typically evaluate them.
Robots in Hospitals — The robots hospitals use beyond surgery, from rehabilitation and telepresence to logistics.
Elderly Care Robots — Companion, telepresence and mobility robots that support older adults and their carers.
Medical Humanoids — Where humanoid robots fit in hospitals and care today, and what still keeps them in pilots.
India's Medical Device Rules — How CDSCO classifies and licenses rehab robots and exoskeletons under the Medical Devices Rules, 2017.
What the Evidence Says — What Cochrane reviews found about robot-assisted walking and arm training after stroke, and their limits.
Exoskeletons at Home — What changes when a powered exoskeleton leaves the clinic: eligibility, training, companions and safety.
Patient Data and Robots — How India's DPDP Act 2023 applies to telepresence, care and therapy robots that collect patient data.
Latest updates — Surgical robots gained a new rival, an exoskeleton won approval for home use and hospital robots grew beyond pilots. These figures and dated updates show what changed and what to ask before you buy.
About us — What we cover, how we source every figure, and who publishes this site.

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