Wellness devices: when India treats them as medical devices

Wellness devices are everywhere: fitness bands, smart rings, sleep trackers and health apps. Most are not medical devices. But some are, and a single claim on a box or an app screen can move a product from one side to the other. This guide explains where India draws the line, what CDSCO’s 2026 software guidance says, and what follows once a product is a medical device.

What makes a product a medical device in India?

The intended purpose decides. India’s device definition, in notification S.O. 648(E) of 11 February 2020, covers devices, including software and accessories, that the maker intends for purposes such as:

• diagnosis, prevention, monitoring, treatment or relief of a disease or disorder;
• diagnosis, monitoring, treatment or relief of an injury or disability;
• investigating, replacing or supporting the anatomy or a body process;
• supporting or sustaining life.

Notice what is missing from the list. Keeping fit, sleeping well and building healthy habits are not medical purposes. So a product that does only those things is not a medical device, even if it uses the same sensors as one.

What does CDSCO say about wellness software?

CDSCO’s Guidance Document on Medical Device Software (Doc No. CDSCO/MD/GD/MDSW/01/2026) answers this directly. It does not apply to software meant only for general wellness, a healthy lifestyle, or tracking body values for fitness. That holds only if the software has no medical purpose.

The guidance defines general wellness software in two parts. It is software that:

• aims to keep up or encourage a general state of health or a healthy activity; or
• links a healthy lifestyle to a lower risk or impact of certain long-term conditions, where it is well accepted that lifestyle plays a part.

It then adds two limits that matter for every product team:

1. No disease claims. Wellness software may talk about general health, but it must not refer to diseases, disorders or pathological conditions.
2. No medical measurement. Software that measures, estimates or reports body values for screening, diagnosis, monitoring, alerts or disease management is not wellness software.

The guidance also confirms that mobile apps, AI software and cloud software count as medical device software when they meet the device definition.

Where is the line for wearables?

The same test applies to the hardware, because the device definition turns on intended purpose. The sensor can be the same on both sides of the line. What changes is the claim and how the product uses the reading.

Claim or feature	Likely side of the line
Counts steps and tracks activity	Wellness
Tracks sleep and suggests better sleep habits	Wellness
Shows heart rate during exercise	Wellness
Measures SpO2 to help monitor a lung condition	Medical device
Alerts the user to a possible irregular heart rhythm	Medical device
Tracks blood pressure for people with hypertension	Medical device

Compare two products. A watch that shows blood oxygen as a general wellness reading, with no medical claim, sits on the wellness side. A pulse oximeter meant for medical measurement of SpO2 is a medical device. CDSCO’s classification lists place the pulse oximeter in Class C.

What pushes wellness devices over the line?

Intended purpose is not just the label. CDSCO’s software guidance says it shows up in the labelling, the instructions for use, websites, promotional material and other information from the maker. So check every place you describe the product.

Watch for these triggers:

• Disease words. Naming a condition, such as diabetes, sleep apnoea or atrial fibrillation, in a claim.
• Medical alerts. Warnings that tell the user they may have a condition.
• Clinical framing. Words like “medical grade” or “clinically accurate”, or a claim to replace a medical device. The US FDA names these as triggers, and they point to a medical purpose in India too.
• Treatment advice. Outputs that guide medicine doses or other treatment.
• Feature creep. A new app update that adds a medical function to a wellness product.

Marketing teams often change claims faster than regulatory teams review them. One new advert can change the status of a product that was fine the week before.

What happens if your product is a medical device?

It then falls under the Medical Devices Rules, 2017. The First Schedule sets its class, from Class A (low risk) to Class D (high risk). Our guide to medical device classification in India walks through the steps.

For software, CDSCO’s guidance adds two points:

• Software that drives or influences a hardware device takes the same class as that device.
• For standalone software, the class depends on how serious the condition is and how much the software’s output matters to the care decision. Software that treats or diagnoses a critical condition is Class D. Software that only informs care for a non-serious condition is Class A.

The class then sets your licence route and evidence plan. See our page on CDSCO medical device registration for the process.

How does the US treat wellness devices?

The US FDA issued its final guidance, General Wellness: Policy for Low Risk Devices, on 6 January 2026. It uses two tests. The product must be meant only for general wellness, and it must be low risk.

The 2026 version speaks to wearables. Products that use non-invasive sensing to estimate values such as blood pressure or oxygen saturation can count as wellness products. They must not be invasive or implanted, must avoid disease claims, and must not prompt clinical action. The FDA also lists features that take a product out of the wellness group, such as disease names, medical alerts and claims of clinical accuracy.

The two countries reach similar answers by different routes. If you sell in both, write one set of claims that passes both tests.

What are the common mistakes with fitness wearables?

We see the same problems with fitness wearables and health apps:

• Assuming the sensor decides. Teams think a product is medical because it has an optical heart sensor, or wellness because it is sold in a sports shop. Neither is true. The claim decides.
• Borrowing words from a medical product. A feature page copied from a medical device brochure can carry disease claims into a wellness product.
• Adding health alerts late. An alert that names a condition is often added near launch. It can turn the whole product into a medical device.
• Treating the app as separate. The app is part of the product. Its screens and store listing count toward the intended purpose.
• Selling the same product with different claims. If the Indian claims are wellness but the claims elsewhere are medical, expect questions about the real intended purpose.

Each of these is easy to fix before launch, and much harder to fix after it. For wellness devices, the safest course is to keep every claim, alert and screen on the wellness side, and to check them again with each update.

What should you do first?

Start with these five steps:

1. Write the intended purpose. Say exactly what the product is for, and who uses it.
2. Audit every claim. Check the label, app store listing, website and adverts for disease words.
3. Check each feature. List what each reading is used for, and whether any alert names a condition.
4. Decide your side of the line. If you want medical claims, plan for a licence. If you do not, remove them.
5. Set a review gate. Make regulatory sign-off part of every new claim and app update.

How Prequel can help

Our team helps device makers and app developers decide which side of the line a product sits on, and build the file if it is a medical device. See our regulatory affairs support service or our work in medical devices.