CDSCO License Charges: A Practical Guide to Fees, Costs, and Budgeting

Ask ten people in the medical device business what a CDSCO license costs, and you’ll probably get ten different answers. That’s because there is no single fee. What you pay depends on whether you manufacture or import, the risk class of your device, and how many devices and sites you’re registering. This guide breaks it down so you can budget before you apply, not after.

Who Charges What?

CDSCO (Central Drugs Standard Control Organisation) and CDSCO License charges work under the Ministry of Health and Family Welfare. For medical devices, the fees are set out in the Second Schedule of the Medical Devices Rules, 2017. You pay online when you submit your application, and the fee challan is part of the document checklist.

One thing to understand first is risk classification. Devices fall into Class A (low risk), Class B (low-moderate), Class C (moderate-high), and Class D (high risk). A higher class means higher fees and a heavier review.

Manufacturing License Fees

For manufacturing, the published fee structure is roughly this:

Device class	Application / License	Site fee	Per-device fee
Class A and B	MD-3 / MD-5	₹5,000	₹500
Class C and D	MD-7 / MD-9	₹50,000	₹1,000

Class A and B applications go to the State Licensing Authority. Class C and D go to the Central Licensing Authority, which is CDSCO itself. So a manufacturer with one Class C site and three distinct devices would pay the site fee once and the device fee three times.

 

Import License Fees

Importers pay in US dollars, and the amounts are higher. Applications are made in Form MD-14, and the license is issued in Form MD-15. For Class C and D devices, the fee is around $3,000 for one manufacturing site and $1,500 for each distinct device. Lower classes cost less, but the structure is the same: one fee for the site, one for each device.

Foreign manufacturers also need an Indian authorised agent to apply on their behalf, and that agent’s service charges are a separate cost.

Costs People Forget to Budget For

The government fee is only part of the real expense. These are the extras that catch teams off guard:

• Retention fee. Licenses under the Medical Devices Rules stay valid indefinitely, but only if you pay the retention fee every five years. Miss the date and you get a grace window with a late fee of about 2% of the retention fee per month. Miss the window too, and the license can lapse.
• Testing and audit costs. Class B, C and D devices may need a notified body audit or inspection, which is billed separately.
• Test licenses. If you need to import or make samples for clinical investigation or evaluation, that is a different license with its own fee.
• Additional devices. Adding a product to an existing license means another fee.
• Documentation work. The Device Master File and Plant Master File take serious time and often require outside help.
• Corrections and re-submissions. Every query round costs time, and time costs money.

Drugs and Cosmetics Are Different

Medical devices are only one slice of CDSCO. Drug import registrations, cosmetic registrations, and other approvals follow separate rules and separate fee schedules. If your product isn’t a medical device, don’t use the numbers above. Check the schedule that applies to your category.

Ways to Keep Costs Under Control

A few habits can save real money:

1. Classify correctly from day one. Applying under the wrong class means rework and sometimes paying twice.
2. Group devices sensibly. Where the rules allow grouping, you may avoid a separate fee for every variant.
3. Prepare documents before paying. A complete file means fewer queries and a shorter timeline.
4. Calendar your retention date. Late fees are the most avoidable cost in the whole process.
5. Check for exemptions. Some devices are exempt from certain provisions under the Eighth Schedule. Verify this before you apply.

 

How UMSPCS Can Help

Fee tables look simple until you apply them to your own product range. At UMSPCS, we help manufacturers, importers, and brands work out their device class, estimate the full cost of licensing, prepare documentation, and follow the application through to the license. We also track retention dates so a renewal never catches you by surprise. If you’d like a clear cost estimate before you commit, our team is happy to walk through it with you.

Final Thoughts

CDSCO license charges are manageable once you know what drives them: class, site, number of devices, and retention. Plan the full cost early, keep your paperwork tidy, and don’t ignore renewal dates. If you want a second pair of eyes on your budget, UMSPCS is here to help.

Frequently Asked Questions

1. How much does a CDSCO manufacturing license cost?
   For Class A and B devices, the site fee is ₹5,000 plus ₹500 per device. For Class C and D, it is ₹50,000 plus ₹1,000 per device.
2. What is the fee for a CDSCO import license?
   Import fees are charged in US dollars and vary by class. For Class C and D devices, it is about $3,000 per site and $1,500 per distinct device.
3. Is the CDSCO license valid forever?
   It remains valid indefinitely as long as you pay the retention fee every five years and follow the rules.
4. What happens if I pay the retention fee late?
   You can pay during a grace period, but a late fee of roughly 2% of the retention fee per month applies. After the grace period, the license may lapse.
5. Do I pay separately for each device?
   Yes. There is a site fee and an additional fee for each distinct device.
6. Can foreign manufacturers apply directly?
   They need an authorised Indian agent to apply for the import license on their behalf.
7. Are there discounts for small businesses?
   The rules don’t offer a general concession for small businesses, though certain exempt devices may avoid some requirements.
8. Are consultancy charges included in the government fee?
   No. Government fees are paid to CDSCO. Consultant or agent charges are separate.