How to Determine Whether Your Product Is a Medical Device Under Indian Law

Determining whether a product qualifies as a medical device under Indian law is the single most important first step for any manufacturer, importer, or innovator planning to enter or expand in the Indian market. Getting this wrong can lead to delayed launches, rejected applications, or enforcement action by the Central Drugs Standard Control Organisation (CDSCO). This guide explains the exact criteria laid down in the Medical Devices Rules, 2017 (MDR 2017) and the subsequent notifications that expanded the regulatory net, so you can make an accurate determination with confidence.

The Legal Foundation: What Exactly Counts as a Medical Device?

Under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, a medical device is defined in two complementary ways. Rule 3(zb) of MDR 2017 originally covered specific categories such as substances used for in-vitro diagnosis, surgical dressings, bandages, staples, sutures, ligatures, and blood bags, plus mechanical contraceptives, disinfectants, and insecticides that had been notified.

The decisive expansion came through Gazette Notification S.O. 648(E) dated 11 February 2020. From 1 April 2020, the Central Government notified the following broad definition:

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on the human body or animals by any pharmacological, immunological or metabolic means, but which may assist in its intended function by such means for one or more of the following specific purposes:

• diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
• diagnosis, monitoring, treatment, alleviation or assistance for any injury or disability;
• investigation, replacement or modification or support of the anatomy or of a physiological process;
• supporting or sustaining life;
• disinfection of medical devices; and
• control of conception.

This definition is technology-neutral and covers hardware, software, and combinations. The key decision points are the manufacturer’s intended use and the mode of action.

Key Tests to Apply When Evaluating Your Product

1. Primary Mode of Action
   If the product achieves its main effect through pharmacological, immunological, or metabolic means, it is generally regulated as a drug, not a medical device. Devices may use these means only as a supporting mechanism.
2. Intended Purpose by the Manufacturer
   The claims made on labelling, instructions for use, promotional material, and technical documentation are decisive. A fitness tracker that only displays step counts and heart rate for general wellness is usually not a medical device. The same hardware that claims to diagnose arrhythmia or monitor a medical condition becomes a medical device.
3. Human or Animal Use
   The product must be intended for use on or in human beings or animals for the medical purposes listed above.
4. Inclusion of Software and Accessories
   Standalone software, mobile apps, or accessories that enable or assist a parent medical device in achieving its intended purpose fall within the definition if they meet the medical purpose criteria.
5. Notified Lists and Classification
   CDSCO periodically publishes risk-classification lists for medical devices and in-vitro diagnostic devices. Even if a product meets the definition, its exact risk class (A, B, C or D) is determined by the Central Licensing Authority with reference to the First Schedule of MDR 2017 and the published lists.

Practical Step-by-Step Determination Process

Step 1: Document the intended use exactly as it will appear in labelling and promotional claims.
Step 2: Compare that intended use against the six specific purposes listed in S.O. 648(E).
Step 3: Confirm that the primary mode of action is not pharmacological, immunological, or metabolic.
Step 4: Check whether the product (or a substantially equivalent one) already appears in any CDSCO classification list.
Step 5: If ambiguity remains, consider submitting a formal classification query or seeking a pre-submission meeting through an authorised Indian agent.
Step 6: Once confirmed as a medical device, apply the risk-classification rules in Part I (or Part II for IVDs) of the First Schedule to determine Class A, B, C or D.

Class A devices are low risk, Class B low-to-moderate, Class C moderate-to-high, and Class D high risk. The class dictates the licensing pathway, quality-management-system requirements, and whether a notified body audit is needed.

Common Borderline Cases

• Wellness versus medical claims for wearables and software
• Combination products that contain both a device and a medicinal substance
• Disinfectants and sterilants for medical devices
• Specimen receptacles and simple laboratory equipment
• Accessories and spare parts specifically intended for use with a parent device

In each case the manufacturer’s documented intended purpose is the primary determinant.

Why Accurate Determination Matters

Incorrect classification can result in the wrong licence application, incomplete technical documentation, or marketing of an unlicensed product. CDSCO has made it clear that all products meeting the S.O. 648(E) definition are regulated under MDR 2017. Early and correct determination protects patients, reduces regulatory risk, and shortens time to market.

How and Why to Choose MDR Consultants

Navigating the precise wording of intended use, the interaction between the Drugs and Cosmetics Act and MDR 2017, and the evolving CDSCO classification lists requires specialised experience. At MDR Consultants we focus exclusively on medical-device regulatory strategy in India. We help clients:

• Perform rigorous product-jurisdiction assessments against the official definition
• Align claims and technical documentation with CDSCO expectations
• Obtain formal classification advice when needed
• Prepare complete dossiers for Class A through D devices and IVDs

We are chosen because we combine deep knowledge of the primary legislation and notifications with practical experience of CDSCO review practices. Our goal is to give manufacturers a clear, defensible determination so they can move forward with confidence rather than uncertainty.

Conclusion

Under Indian regulations a product is a medical device when it meets the definition notified in S.O. 648(E) read with MDR 2017—namely, when it is intended by the manufacturer for one of the specified medical purposes and does not achieve its primary action by pharmacological, immunological or metabolic means. The determination rests on intended use, mode of action, and reference to CDSCO classification guidance. Applying these tests systematically at the outset of any development or market-entry project is essential for regulatory compliance and commercial success in India. When the analysis is complex, partnering with experienced regulatory specialists ensures the conclusion is both accurate and defensible before CDSCO.

Last Updated : 08 Sep 2026