Importing medical devices into India involves strict regulatory compliance under the Medical Device Rules, 2017 and oversight by the Central Drugs Standard Control Organisation (CDSCO). For medical device importers in Delhi, obtaining the correct CDSCO MD-15 licence is a mandatory legal step before customs clearance, distribution, or sale of imported medical devices.
In simple terms, the medical device import licence in Delhi process uses two forms:
- Form MD-14 – Application for an import licence
- Form MD-15 – Import licence granted by CDSCO after review and approval
This guide explains, in detail, how to obtain the medical device importer Delhi CDSCO MD-15 licence, including eligibility, documentation, process, validity, compliance obligations, and common issues.
What Is the CDSCO MD-15 Licence?
A CDSCO MD-15 licence is also an import licence generated by the Central Drugs Standard Control Organisation according to the Medical Device Rules, 2017. It provides official permission to import certain categories of medical devices into the territory of India.
To be awarded MD-15, an importer submits an application in Form MD-14, through the CDSCO online portal (SUGAM). With the application in, the MD-15 import licence is granted by CDSCO, permitting the devices in question to clear customs and be imported legally into India
Who Needs an MD-15 Licence?
An MD-15 licence is required if:
- You are importing Class A (sterile/measuring), Class B, Class C, or Class D medical devices into India for commercial distribution.
- You are an authorised Indian importer appointed by a foreign manufacturer.
- You intend to sell, distribute, or market medical devices in India.
Note: Only Class A non-measuring, non-sterile devices are exempt from MD-15 and follow the registration route instead.
Which Medical Devices Require an MD-15 Licence?
Under the updated regulatory regime, all medical devices except a limited category of Class A non-sterile and non-measuring devices require a CDSCO MD-15 import licence for legal importation.
| S.No. | Device Class | Risk Level | MD-15 License Required |
| 1. | Class A (measuring/sterile) | Low | Yes |
| 2. | Class A (non-measuring, non-sterile) | Low | Exempt from import licence (requires registration) |
| 3. | Class B | Low–moderate | Yes |
| 4. | Class C | Moderate–high | Yes |
| 5. | Class D | High | Yes |
This means that most Class A, B, C, and D medical devices need a valid MD-15 licence before import.
Why Delhi Is a Preferred Location for Medical Device Importers?
Although the MD-15 licence is valid throughout India, Delhi is often preferred by medical device importers because:
- CDSCO headquarters is located in New Delhi, facilitating easier coordination
- Proximity to regulatory offices and faster query resolution
- Access to experienced regulatory consultants
- Close to Indira Gandhi International Airport for air cargo imports
Being in Delhi helps streamline regulatory interactions but is not mandatory for obtaining an MD-15 licence.
Step-by-Step Process for MD-14 & MD-15 Application
Step 1: Device Classification
Determine the correct risk class (A/B/C/D) for your medical device according to CDSCO guidelines.
Step 2: Appoint an Authorized Indian Agent
A foreign manufacturer must appoint an Indian importer or authorised agent who holds a valid wholesale or manufacturing licence to submit the MD-14 application.
Step 3: Prepare Documentation
Gather all required documents, including quality, safety, and regulatory compliance evidence.
Step 4: Submit Form MD-14 Online
The authorised agent submits Form MD-14 on the CDSCO SUGAM portal along with supporting documents.
Step 5: CDSCO Evaluation
CDSCO reviews the application, classification, and compliance documentation. They may raise queries, which must be answered promptly.
Step 6: Grant of Form MD-15 Licence
Once CDSCO is satisfied, it issues the MD-15 import licence, legally authorising the importer to bring the devices into India.
Documents Required for MD-15 Licence
The typical documents needed include:
- Covering letter and Power of Attorney from the foreign manufacturer
- Free Sale Certificate or equivalent from the country of origin
- Device Master File (DMF) and Plant Master File (PMF)
- ISO 13485 certificate and quality documentation
- Device labels and Instructions for Use (IFU)
- Importer’s valid wholesale or manufacturing licence
- Declaration of conformity and other regulatory documents
Validity and Renewals
- The MD-15 licence has perpetual validity, provided the retention fee is paid every 5 years and you remain compliant. If retention fees are not paid, CDSCO may suspend and then cancel the licence.
Post-Licence Compliance for Importers
After obtaining the MD-15 licence, importers must:
- Maintain import and distribution records
- Report adverse events under the Materiovigilance Programme of India
- Inform CDSCO of changes in manufacturing site, labelling, or device specifications
- Ensure ongoing compliance with Medical Device Rules, 2017 and any updated notifications
Common Mistakes to Avoid
- Incorrect device classification
- Submitting incomplete or inconsistent documentation
- Failure to appoint a proper authorised agent
- Ignoring CDSCO queries or timelines
- Not paying retention fees on time
Avoiding these issues helps ensure smoother approval and customs clearance.
Conclusion
To import most medical devices into India legally requires obtaining a medical device importer Delhi CDSCO MD-15 Licence. To properly obtain this licence, you will need to work on obtaining accurate device classification, complete the necessary documentation, online submit MD-14 and follow this process through to the end until you obtain MD-15. Efficiently achieving this licence and growing your import potential in the Indian market can be achieved with the right guidance and adequate planning.
Is a CDSCO MD-15 licence mandatory for importing medical devices into India?
Yes, an MD-15 licence is mandatory for importing most medical devices into India, except certain exempted Class A non-sterile and non-measuring devices.
What is the difference between Form MD-14 and Form MD-15?
Form MD-14 is the application submitted online, while Form MD-15 is the import licence issued by CDSCO after approval.
Are all Class A medical devices exempt from the MD-15 licence requirement?
No, only Class A non-sterile and non-measuring devices are exempt; Class A sterile or measuring devices require an MD-15 licence.
Can a foreign manufacturer apply for an MD-15 licence directly?
No, a foreign manufacturer must appoint an authorised Indian agent or importer to submit the MD-14 application.
Is the MD-15 licence valid across all Indian ports?
Yes, the MD-15 licence is valid for importing medical devices through all ports in India.
How long does an MD-15 license last?
Subject to payment of retention fees on time, the MD-15 license is perpetual.
What if the retention fee for MD-15 is not paid on time?
Licenses will be suspended or cancelled as a result of not paying a retention fee.
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