India sorts medical devices into four risk classes, A to D, under the Medical Devices Rules, 2017 (MDR 2017). The class decides which licence a device needs, who grants it, and how much evidence the application has to carry. Getting it right is the first step of any CDSCO medical device registration.
The four classes
| Class | Risk level | Indicative examples |
|---|---|---|
| A | Low | Tongue depressors, absorbent cotton, non-sterile examination products |
| B | Low to moderate | Hypodermic needles, suction equipment, clinical thermometers |
| C | Moderate to high | Ventilators, infusion pumps, bone fixation plates and screws |
| D | High | Heart valves, coronary stents, implantable defibrillators |
Examples are indicative only. The same kind of product can sit in different classes depending on its intended use, so always check the specific device.
In-vitro diagnostic (IVD) devices are also classified A to D, using separate rules based on the risk to the patient and to public health.
How the class is decided
The rules are set out in the First Schedule of MDR 2017 and follow the approach used internationally by the GHTF and IMDRF. The main factors are:
- Intended use stated by the manufacturer, which matters more than what the device looks like
- Duration of contact: transient, short term or long term
- Invasiveness: whether it enters the body through an orifice, surgically, or is implanted
- Active or not: whether it depends on electrical or other energy
- Body part: devices in contact with the heart, central circulatory system or central nervous system are classed higher
- Medicinal substances or animal tissue in the device, which push the class up
Where more than one rule applies, the higher class is used.
CDSCO’s classification lists
CDSCO has published risk classification lists for many device categories, such as cardiology, orthopaedics, dental, ophthalmic and general hospital devices. These are on the medical devices section of cdsco.gov.in. If a device appears in a list, that class applies. If it doesn’t, the class is worked out from the First Schedule rules, and the reasoning should be set out in the Device Master File.
Why the class matters
| Class A | Class B | Class C | Class D | |
|---|---|---|---|---|
| Manufacturing licence | MD-5 from the State Licensing Authority | MD-5 from the State Licensing Authority | MD-9 from CDSCO | MD-9 from CDSCO |
| Import licence | MD-15 from CDSCO | MD-15 from CDSCO | MD-15 from CDSCO | MD-15 from CDSCO |
| Site check | Notified body audit within 120 days after grant | Notified body audit before grant | CDSCO inspection before grant | CDSCO inspection before grant |
| Licensing for devices brought under the rules in 2020 | 1 October 2022 | 1 October 2022 | 1 October 2023 | 1 October 2023 |
One group of Class A devices is treated differently: those that are non-sterile and non-measuring do not need a manufacturing or import licence. Since October 2022 they are registered on CDSCO’s online portal instead, with no government fee, although labelling rules still apply.
A higher class also means a heavier dossier: more test data, and for new devices without a predicate, possibly clinical investigation. Importers should read our page on the medical device import licence (MD-14/MD-15).
Do medical devices need BIS too?
Generally, CDSCO is the regulator for medical devices, not BIS. A few medical products are also covered by BIS Quality Control Orders, including diagnostic medical X-ray equipment and medical textiles. X-ray equipment is also regulated by the Atomic Energy Regulatory Board (AERB) through its eLORA portal. Wireless devices may need WPC approval, and electrical and electronic equipment can fall under the e-waste EPR rules. Check each one for your product.
Not sure of your device’s class? Aaditech offers a free first consultation to confirm the class and the licence route before you prepare a dossier.