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What is Not a Medical Device?

Several categories of articles are explicitly excluded from the medical device definition or fall outside the scope of the Medical Devices Rules 2017.

Articles achieving their action through pharmacological or biological means​

If an article achieves its primary intended purpose through pharmacological, immunological, or metabolic means, it is regulated as a drug under the Drugs and Cosmetics Act 1940 — not as a medical device.

Examples: tablets, injections, topical creams, vaccines, blood products, gene therapy products.

Combination products — where a drug and device are integral — are subject to case-by-case determination by CDSCO.

Articles not yet notified under MDR 2017​

India's MDR 2017 applies only to device types listed in Schedule I and Schedule II. Devices not yet notified fall outside CDSCO licensing requirements, though manufacturers should monitor gazette notifications for expansion of scope.

Cosmetics and toiletries​

Products such as skin moisturisers, shampoos, and perfumes that carry no therapeutic or diagnostic claim are regulated under the Drugs and Cosmetics Act as cosmetics, not devices.

General wellness products​

Fitness trackers, step counters, and lifestyle apps that make no diagnostic or therapeutic claims are not considered medical devices — unless software functionality meets the SaMD definition with clinical claims.

Ayurvedic, Siddha, and Unani (AYUSH) products​

Traditional AYUSH products are primarily regulated under their own framework. Borderline products with device-like functions may require case-by-case determination. See AYUSH Borderline Devices.

Food products​

Nutritional supplements, functional foods, and nutraceuticals regulated under the Food Safety and Standards Act 2006 (FSSA) are not medical devices, even if they carry health claims.