Medical device classification in India: how it works

Medical device classification in India decides almost everything that comes after it. It sets who licenses you, which forms you file and how much evidence you need. This guide walks through the four classes, who decides, and how to place your own device, step by step.

What are the four medical device classes in India?

The Medical Devices Rules, 2017 use four classes. Rule 4 sets them out by risk:

• Class A: low risk.
• Class B: low to moderate risk.
• Class C: moderate to high risk.
• Class D: high risk.

A simple device that touches only intact skin sits at the low end. A long-term implant in contact with the heart sits at the top. Most products fall somewhere in between, and that is where the detail matters.

Since February 2020, the Rules cover all medical devices, not just a notified list. CDSCO’s FAQs tie this to notification S.O. 648(E), dated 11 February 2020.

Who decides medical device classification in India?

The Central Licensing Authority (CLA) at CDSCO decides. Rule 4(3) tells it to classify each device by its intended use and the rules in the First Schedule. CDSCO’s FAQs go further: only the CLA can classify a device.

CDSCO also publishes class-wise lists of devices on its medical device page. The CLA can add to these lists or change them. So your own view of the class is a starting point. The CLA’s view is the one that counts.

How do you classify a medical device in India, step by step?

You can work out a sound first answer yourself. Follow these six steps in order.

Step 1: Write down the intended purpose and the risk

The intended purpose governs the class. This is the first basic principle in Part I of the First Schedule. Write one clear sentence: what the device does, for whom, on which part of the body, and for how long. Take it from your label and your instructions for use, because the CLA will read those too.

Then think about risk. Ask what would happen to the patient if the device failed, or gave a wrong result, at the worst moment. The four classes rise with this risk, so the answer tells you where to look. A device that sits in the heart or keeps a patient alive will land near the top. CDSCO’s 2017 notice, for example, lists heart valves as Class D.

This question points you in the right direction, but the rules still decide the class. CDSCO’s classification lists place ventilators, such as high-frequency and neonatal intensive-care ventilators, in Class C, even though a ventilator failure can be life-threatening. So always check your answer against the lists and the First Schedule.

Step 2: Check CDSCO’s class-wise lists

Search the CDSCO lists for your device type. If it is there, note the class and the list entry. If it is close but not exact, keep going and check the rules yourself.

Step 3: Note how the device touches the body, and for how long

The rules turn on contact and duration. The Rules define three time bands:

• Transient: continuous use for less than 60 minutes.
• Short term: from 60 minutes up to 30 days.
• Long term: more than 30 days.

Then ask how the device enters the body, if it does. Some devices stay outside. Some go into a body opening, such as the mouth. Some go through the skin by surgery. Some are implants. Each answer points to a different rule.

Step 4: Apply the rules in the First Schedule

Part I of the First Schedule has 18 rules for devices other than in vitro diagnostics. They fall into broad groups:

• non-invasive devices;
• devices that enter a body opening;
• surgically invasive devices;
• implants and long-term surgical devices;
• active devices, which run on a power source;
• special cases, such as devices with a medicinal product, devices made from tissue, sterilisers and contraceptives.

A few examples show how the rules work:

• A non-invasive device that touches only intact skin, or does not touch the person at all, is usually Class A.
• A long-term implant is Class C. It moves up to Class D if it touches the heart, the central circulation or the central nervous system. It also moves up if it supports life, is active, or the body absorbs it.
• A device that includes a medicine with a helping action is Class D.
• A device that sterilises other devices is Class C.

Step 5: Apply the basic principles

Part I opens with a short set of principles. Read them before you settle on a class:

• Accessories get their own class, apart from the device they serve.
• Software that drives or controls a device takes the same class as that device.
• Most critical use applies when a device is not meant for one part of the body alone.
• The strictest rule wins. If two or more rules fit, the device takes the higher class.

The last principle catches many teams out. One feature can lift the whole device into a higher class.

Step 6: If your device is not listed, ask the CLA

If you still cannot place the device, you can ask the CLA to classify it. CDSCO’s FAQs list what to send: the label, the instructions for use and the device’s regulatory status in other countries. CDSCO then updates its lists.

How are in vitro diagnostic devices classified?

In vitro diagnostic (IVD) devices use the same four classes, A to D. They follow a separate set of rules in Part II of the First Schedule. Rule 4(2) points to it.

The IVD rules look at what the test detects and who uses it. There are rules for tests for transmissible agents, for blood grouping and tissue typing, for self-testing and for near-patient testing. A test that screens blood for a serious infection sits much higher than a general lab reagent.

What does the class change for your licence?

The class sets your licensing route. CDSCO’s regulatory pathway chart shows the forms for each case:

Activity	Class	Apply on	Licence on	Who licenses
Manufacture	A and B	Form MD-3	Form MD-5	State Licensing Authority
Manufacture	C and D	Form MD-7	Form MD-9	Central Licensing Authority
Import	All classes	Form MD-14	Form MD-15	Central Licensing Authority

Two points matter for low-risk products. First, Class A devices that are non-sterile and have no measuring function are exempt from the licence chapters. They still need registration on CDSCO’s online portal, and they must meet the labelling rules. Second, the pathway chart notes that a clinical investigation is not mandatory for Class A devices.

Higher classes carry more weight at review. That is why a careful risk management file under ISO 14971 helps. It shows the regulator how you found and controlled each hazard. You can read more on the whole licence process in our guide to CDSCO medical device registration.

What are the common classification mistakes?

We see the same few problems again and again:

• Copying a foreign class. CDSCO says its system is harmonised with global ones, but the Indian rules and lists still decide.
• Ignoring the software. Software that drives a device takes the device’s class.
• Writing a vague intended purpose. Loose wording on the label can pull a device into a higher class.
• Stopping at the first rule that fits. If two rules apply, the stricter one wins.
• Forgetting accessories. Each one needs its own class.
• Missing a built-in medicine. A device with a medicine that helps it work is usually Class D. Our guide to drug-device combination products explains how India treats them.

When should you check your medical device classification again?

A class is not fixed for life. Check it again whenever one of these things happens:

• You change the intended purpose. A new claim on the label can move the device into a new class.
• You add a feature. New software, a power source or a medicine can each lift the class.
• CDSCO updates its lists. Rule 4(4) lets the CLA add, delete or change entries, so an old answer can go out of date.

Keep a short note in your technical file. Record the class, the rule you used, the list entry and the date you last checked. This makes your medical device classification easy to defend when a reviewer asks how you reached it.

How Prequel can help

Our team helps device makers and importers place each product in the right class and build the file that supports it. See our regulatory affairs support service, or explore our work across the medical devices sector. If you want a quick view of where you stand, start with the free readiness assessment.