CDSCO Registration Fees & Process 2026: Medical Devices and Cosmetics (Fee Table)

Every medical device and every imported cosmetic sold in India needs approval from the Central Drugs Standard Control Organisation (CDSCO). The fee you pay depends on what you are doing (import or manufacture), the risk class of the device and how many sites and products are covered.

This guide puts the 2026 CDSCO fees in one place, then explains the process and documents. For background on CDSCO itself, see our CDSCO guide.

India Medical Device Classification

Class	Risk	Examples
A	Low	Bandages, tongue depressors, many non-sterile instruments
B	Low-moderate	Thermometers, BP monitors, hypodermic needles
C	Moderate-high	Ventilators, bone fixation implants, infusion pumps
D	High	Heart valves, implantable defibrillators, some IVDs

The class decides the fee, the licensing authority and the documents. Our guide to CDSCO risk classification explains how classes are assigned.

Medical Device Import Licence Fees (Form MD-14)

Class	Per manufacturing site	Per distinct device
A	USD 1,000	USD 50
B	USD 2,000	USD 1,000
C and D	USD 3,000	USD 1,500

In Vitro Diagnostic (IVD) Import Fees

Class	Per manufacturing site	Per distinct IVD
A and B	USD 1,000	USD 10
C and D	USD 3,000	USD 500

If CDSCO decides to inspect the overseas manufacturing site, the inspection fee is USD 6,000.

Medical Device Manufacturing Licence Fees

Class	Per manufacturing site	Per distinct device	Licensing authority
A and B	₹5,000	₹500	State Licensing Authority
C and D	₹50,000	₹1,000	Central Licensing Authority (CDSCO)

Cosmetics Import Registration Fees (Form COS-1)

Item	Fee
Per category of cosmetics	USD 1,000
Per manufacturing site	USD 500
Per variant	USD 50

Fees are paid online and are not refundable. Government fees change from time to time, so confirm the current schedule before filing.

Validity

• Medical device import and manufacturing licences remain valid unless suspended or cancelled, provided the licence retention fee is paid every five years.
• Class A non-sterile, non-measuring devices only need registration on the online portal.
• Cosmetics registrations have their own validity and renewal rules under the Cosmetics Rules, 2020.

CDSCO Registration Process for Medical Device Imports

1. Classify the device and identify the forms.
2. Appoint an Indian Authorised Agent with a wholesale licence.
3. Prepare the Device Master File and Plant Master File, plus free sale certificate, ISO 13485 certificate, test reports and labels.
4. Apply online on Form MD-14 and pay the fee.
5. Answer queries from CDSCO.
6. Licence granted on Form MD-15.

Cosmetics Import Process

1. Appoint the Indian importer or authorised agent.
2. Prepare documents: manufacturing licence or free sale certificate, formula, labels, safety data and specifications.
3. Apply on Form COS-1 on the SUGAM portal and pay the fee.
4. Registration certificate issued on Form COS-2.

See our CDSCO cosmetics registration service.

How Long Does It Take?

Timelines depend on the class, completeness of the file and queries. Class A and B applications move faster than Class C and D, which get more detailed review. A complete, well-organised file is the biggest factor in avoiding delay.

Common Mistakes

• Wrong class. It changes the fee and the authority, and a wrong class can lead to rejection.
• Counting devices incorrectly. Fees are per distinct device, so group carefully within the rules.
• Weak master files. Missing risk analysis, clinical evidence or labels causes queries.
• Agent without the right licence. The authorised agent must hold a valid wholesale licence.

How Instacertify Helps

We classify devices, prepare master files, act with your authorised agent and file on the CDSCO portals until approval. See our CDSCO medical device registration service.