CDSCO medical device classification and how to find your class

CDSCO medical device classification in India, Class A to D

CDSCO medical device classification uses four risk classes under India's Medical Devices Rules, 2017 (MDR 2017). Class A is low risk, Class B low moderate, Class C moderate high and Class D high. For the classification of medical devices in India, match intended use against the class-wise lists from CDSCO's Central Licensing Authority. The Rules were notified as G.S.R. 78(E) on 31 January 2017 and apply from 1 January 2018.

How the classification rules work

Rule 4 splits devices into two tracks. Devices other than in vitro diagnostics are classed using Part I of the First Schedule. IVDs use Part II, and the same four classes. Under Rule 4(3), the Central Licensing Authority classifies each device "based on the intended use of the device and other parameters specified in the First Schedule." It can also add or delete devices from the lists, or change a device's class over time (MDR 2017, Rule 4).

Medical device grouping under Rule 5 is separate from risk classification: it lets licence applicants group devices under Ministry of Health and Family Welfare guidelines.

Part I of the First Schedule sets these basic principles:

• Intended purpose governs the class.
• Devices used in combination are classed separately. Accessories are classed in their own right.
• Software that drives a device, or influences how that device is used, falls automatically into the same class.
• A device not limited to one body part is classed on its most critical specified use.
• If several rules apply, "the strictest rules resulting in the higher classification shall apply."

Intended duration changes the class. Transient use is intended continuous use for less than 60 minutes, short term is from 60 minutes up to 30 days, and long term is more than 30 days (Rule 3).

Medical device risk classification at a glance

These are general rules from First Schedule Part I, not a substitute for the listed intended use.

First Schedule Part II classes IVDs separately. Class D covers tests that screen blood, tissues or organs for transmissible agents before transfusion or transplant, and blood grouping for ABO, rhesus and certain other systems. Class C includes sexually transmitted agents, cancer screening, human genetic testing, self-testing and near-patient blood glucose. Class B covers self-tests that are not medically critical. Class A is limited to reagents and articles specified for an IVD procedure, IVD instruments and specimen receptacles. Calibrators take the class of their reagent. Any other IVD is Class B.

Where to find the CDSCO classification lists

CDSCO keeps the lists on its Medical Device and Diagnostics page. IVD lists have their own In Vitro Diagnostics page.

The first classification notice came out on 1 November 2017. Specialty lists (anesthesiology, cardiovascular, dental, ENT, oncology, rehabilitation and others) followed from July 2021 to October 2022. Start with the merged risk classification file. Each entry gives the device name, intended use and class. Some examples:

• Class A: cotton crepe bandage, elastic adhesive bandage
• Class B: inhalational analgesia unit, laryngectomy tube
• Class C medical device: pulse oximeter (Anesthesiology list)
• Class D: implantable pacemaker pulse generator, replacement heart valve, ventricular bypass (assist) device

Newer final lists on the same page replace the 6 January 2025 drafts: Class A non-sterile and non-measuring devices (31 October 2025), interventional radiology and radiotherapy (27 November 2025) and oncology (2 January 2026). The listings page still marks the 1 April 2025 cardiovascular and neurological update as a draft. Check for a final notice before you rely on it.

For diagnostics, use the IVD classification list, last updated 25 October 2023. Read the intended use column, not just the device name. An alcohol analyser for body fluids is Class A for lab use but Class C for near-patient testing.

What to do if your device is not listed

Only the Central Licensing Authority can classify a medical device, says the CDSCO FAQ (Q77). Your own reading of the First Schedule is a working estimate. If the device is missing, you send a request with the label, IFU and the regulatory status in other countries (Q78). CDSCO tells you the class and updates the list.

Send that request through the risk classification module on cdscomdonline.gov.in, live for non-IVD devices since 27 November 2025. The IVD module followed on 2 February 2026.

If an imported device is classed differently in IMDRF (GHTF) countries than in India, the Licensing Authority may consider the higher class (FAQ Q93). India's labels are Class A to D, not the US or EU Class I to III numbers. And veterinary devices follow the First Schedule and the same class as in the risk classification notice (FAQ Addendum 03).

Why the class matters for licensing

The class decides who licenses you. Under Rule 8, the Central Licensing Authority handles import of every class, and manufacture of Class C and Class D. State Licensing Authorities handle manufacture for sale or distribution of Class A and Class B, and sale of every class. For a standard manufacturing licence, Class A and B makers apply in Form MD-3 and receive Form MD-5. Class C and D makers apply in Form MD-7 for an MD-9 licence, and importers use Form MD-14 for an MD-15 licence. Class B needs a Notified Body audit before grant. Class A medical devices that still need a licence get a Notified Body audit within 120 days after grant (MDR 2017; CDSCO FAQ Q80).

Licensing became mandatory for Class A and B on 1 October 2022 and for Class C and D on 1 October 2023, ending the registration phase set by G.S.R. 102(E).

Class A medical devices that are non-sterile and non-measuring are the exception. G.S.R. 777(E) exempts them from manufacturing and import licensing, but only if they're registered on the online system. G.S.R. 744(E) was notified on 14 August 2026 and applies from its publication in the Gazette. Registration now covers quality management system conformity as well as standards. Rule 4 is unchanged.

RegAffairs AI's answer on CDSCO classification cites the Rules and lists behind each class.