CDSCO medical device FAQ
26 answers on medical device licensing, checked against the Medical Devices Rules, 2017 and CDSCO notifications.
- Dealers, distributors and online sellers
- Importers and Indian manufacturers
- Medical devices and IVDs only, under the Medical Devices Rules, 2017
CDSCO medical device guide: all topics
Basics
What is a CDSCO medical device licence?
A licence or registration under the Medical Devices Rules, 2017 to sell, import or manufacture medical devices and in-vitro diagnostics in India. Depending on the activity and device class it is issued by CDSCO (the Central Licensing Authority) or the State Licensing Authority.
Do I need a licence to sell medical equipment?
Yes. Anyone who sells, stocks, exhibits or distributes medical devices without a drug sale licence must hold MD-42 registration, under G.S.R. 754(E) of 30 September 2022. See MD-42 registration.
Who issues the licence in Karnataka?
MD-42 sale registration and Class A/B manufacturing licences are issued by the State Licensing Authority, which in Karnataka is the Drugs Control Department. Import licences and Class C/D manufacturing licences are issued by CDSCO.
Does a hospital need a CDSCO licence to use medical devices?
No. Hospitals and clinics do not need a CDSCO licence just to use devices. They should buy from licensed importers, manufacturers and MD-42 registered dealers.
How many classes of medical devices are there in India?
Four: Class A (low risk), B (low to moderate), C (moderate to high) and D (high risk).
How do I find my device’s class?
Apply the classification rules in the First Schedule of the Medical Devices Rules, 2017, and check the classification lists CDSCO publishes.
Sale and distribution (MD-42)
Who needs MD-42 registration?
Every person who sells, stocks, exhibits or offers for sale or distributes medical devices, including IVDs, and does not already hold a drug sale licence.
What is the MD-42 fee?
Rs 3,000, as listed in the Second Schedule of the Medical Devices Rules.
How long is MD-42 valid?
It remains valid in perpetuity, subject to payment of the retention fee.
What staff is needed for MD-42?
Competent technical staff: a registered pharmacist, or a graduate, or a person who has passed 12th standard with one year of experience in selling medical devices.
Does a pharmacy with a drug licence need MD-42?
No. A holder of a drug sale licence in Form 20/21 does not need separate MD-42 registration to sell medical devices.
Is MD-42 needed for online sale of medical devices?
Selling, stocking or distributing devices from a premises needs MD-42 unless you hold a drug sale licence.
Import
Who can apply for a medical device import licence?
The foreign manufacturer’s authorised agent in India, which can be the manufacturer’s own subsidiary.
Which form is used to import medical devices?
Application in Form MD-14; the licence is granted in Form MD-15 by the Central Licensing Authority (CDSCO).
What is the import licence fee for Class B devices?
US$ 2,000 per overseas site and US$ 1,000 per distinct device, under the Second Schedule.
Can a new device without a predicate be imported?
It needs separate permission from CDSCO (rule 63), with a fee of Rs 50,000, before the import licence.
Is the import licence valid for life?
Yes, it remains valid in perpetuity if the import licence retention fee is paid on time.
Manufacturing
Who issues a manufacturing licence for Class A and B devices?
The State Licensing Authority, in Form MD-5, after an audit by a notified body registered with CDSCO.
Who issues a manufacturing licence for Class C and D devices?
CDSCO, the Central Licensing Authority, in Form MD-9, after its own inspection.
What is the manufacturing licence fee?
Class A/B: Rs 5,000 per site + Rs 500 per distinct device. Class C/D: Rs 50,000 per site + Rs 1,000 per distinct device.
Is ISO 13485 required?
The Fifth Schedule quality management system is required; it is aligned with ISO 13485, which most manufacturers adopt.
Do Class A non-sterile, non-measuring devices need a licence?
They are exempt from licensing under G.S.R. 777(E) of 14 October 2022, but must be registered on the online portal.
Validity and Medasus
Are CDSCO medical device licences valid for life?
Licences and the MD-42 certificate remain valid in perpetuity under the Rules, provided the retention fee is paid on time and the licence is not suspended or cancelled.
Does Medasus issue CDSCO licences?
No. Only CDSCO and the State Licensing Authority grant licences. Medasus is a consultancy that prepares and files your application and documents.
Where is Medasus based?
Bengaluru, Karnataka.
How do I start?
Send what you sell, import or make and your city through the form, or WhatsApp +91 99165 15255, for a free licence check.
Get a free CDSCO licence check
Tell us what you do (sell, import or manufacture), the devices and their class if known, and your city. We will tell you which licence you need, the forms, fees and documents.
Need a medical device licence?
Talk to the Medasus regulatory team in Bengaluru. We prepare applications, documents and quality systems for MD-42, import and manufacturing licences.
Last reviewed on 2 November 2026 against: CDSCO: Medical Devices Rules, 2017 and notifications; CDSCO online medical device portal: fee schedule (Second Schedule); Drugs Control Department, Karnataka. Medasus Healthcare Pvt Ltd is a private consultancy that helps establishments prepare and file applications. Licences and approvals are granted only by the respective government departments; Medasus cannot guarantee approval or timelines. Rules and fees change, so always check the official source before applying.
