CDSCO licensing for medical devices
Sell, import or manufacture medical devices legally. We tell you which licence you need and file it for you.
- Dealers, distributors and online sellers
- Importers and Indian manufacturers
- Medical devices and IVDs only, under the Medical Devices Rules, 2017
Medical devices and in-vitro diagnostics in India are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Medical Devices Rules, 2017. This guide covers the licences for dealers, distributors, importers and manufacturers of medical devices: MD-42 sale registration, the MD-15 import licence and the MD-5 / MD-9 manufacturing licences, how devices are classified, and the official fees. It covers medical devices only, not drugs.
CDSCO medical device guide: all topics
- CDSCO medical device licences (overview)
- MD-42 sale and distribution registration
- Import licence (MD-14 / MD-15)
- Manufacturing licence (MD-5 / MD-9)
- Device risk classification (Class A to D)
- CDSCO medical device FAQ
Which CDSCO licence do you need?
| What you do | Apply in | Licence / certificate | Issued by |
|---|---|---|---|
| Sell, stock, exhibit or distribute medical devices (without a drug sale licence) | MD-41 | MD-42 registration | State Licensing Authority (Karnataka: Drugs Control Department) |
| Import medical devices or IVDs (any class) | MD-14 | MD-15 | Central Licensing Authority (CDSCO) |
| Manufacture for sale, Class A or B | MD-3 | MD-5 | State Licensing Authority |
| Manufacture for sale, Class C or D | MD-7 | MD-9 | Central Licensing Authority (CDSCO) |
| Manufacture for clinical investigation, test, evaluation or training | MD-12 | MD-13 | Central Licensing Authority |
Details: MD-42 registration, import licence, manufacturing licence.
How medical devices are classified
Every device falls into one of four risk classes. The class decides who licenses manufacture, the fees and the quality checks.
| Class | Risk | Typical examples | Manufacturing licence from |
|---|---|---|---|
| A | Low | Bandages, tongue depressors, alcohol swabs | State Licensing Authority (MD-5) |
| B | Low to moderate | Hypodermic needles, suction equipment | State Licensing Authority (MD-5) |
| C | Moderate to high | Ventilators, bone fixation plates | CDSCO (MD-9) |
| D | High | Heart valves, implantable defibrillators | CDSCO (MD-9) |
Examples are illustrative. The class of your exact device is fixed by the First Schedule rules and the classification lists CDSCO publishes; always check the current list for your product.
More: device classification guide.
Key rules in force
- Sale registration (MD-42): G.S.R. 754(E) of 30 September 2022 requires anyone who sells, stocks, exhibits or distributes medical devices without a drug sale licence to register the premises. The certificate is valid in perpetuity, subject to the retention fee.
- Class A exemption: G.S.R. 777(E) of 14 October 2022 exempted non-sterile, non-measuring Class A devices from licensing; they must still be registered on the online portal.
- Import: applied for by the foreign manufacturer’s authorised agent in India, in Form MD-14.
- Manufacture: needs a quality management system meeting the Fifth Schedule, with an audit by a notified body (Class A/B) or an inspection by CDSCO (Class C/D).
- Applications are filed online on CDSCO's medical device portal.
Official fees at a glance
- MD-42 sale registration: Rs 3,000
- Manufacturing, Class A/B: Rs 5,000 per site + Rs 500 per device
- Manufacturing, Class C/D: Rs 50,000 per site + Rs 1,000 per device
- Import, Class A: US$ 1,000 per site + US$ 50 per device; Class B: US$ 2,000 + US$ 1,000; Class C/D: US$ 3,000 + US$ 1,500
How Medasus helps
- Tells you which licence and class apply to your products
- Prepares Form MD-41, MD-14, MD-3 or MD-7 with the supporting documents
- Device master file, plant master file and quality management system documents for manufacturers
- Portal registration, filing, query replies and inspection readiness
- Licensed, CDSCO-compliant equipment for hospitals from our medical equipment store
Setting up a hospital or clinic instead? See all hospital and clinic licences in Karnataka.
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.
CDSCO medical device licence: frequently asked questions
What is a CDSCO medical device licence?
Do I need a licence to sell medical equipment?
Who issues the licence in Karnataka?
Does a hospital need a CDSCO licence to use medical devices?
Are CDSCO medical device licences valid for life?
What is the MD-42 fee?
Does Medasus issue CDSCO licences?
See all CDSCO medical device questions
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.
