How to Add a New Medical Device to an Existing Import Licence (MD-15) Under CDSCO Guidelines

The Indian medical device market continues to expand rapidly, leading many importers and foreign manufacturers to introduce additional products under their existing CDSCO Import Licence (Form MD-15). Instead of applying for a completely new import licence, CDSCO allows applicants to add additional medical devices under an already approved MD-15 licence, provided specific regulatory conditions are met.

In this guide, MDR Consultants explains the CDSCO procedure, documentation requirements, fees, and regulatory considerations for adding a new medical device to an existing MD-15 Import Licence under the Medical Devices Rules (MDR), 2017.

What is Form MD-15?

Form MD-15 is the Import Licence issued by the Central Licensing Authority (CLA), CDSCO, allowing authorized Indian agents to import notified medical devices into India. The licence is granted upon approval of an application submitted in Form MD-14. Under Rule 34 and Rule 36 of the Medical Devices Rules, 2017, imported medical devices must obtain CDSCO approval before entering the Indian market.

Can Additional Medical Devices Be Added to an Existing MD-15 Licence?

Yes.

CDSCO permits the addition of new medical devices under an existing MD-15 Import Licence when:

• The legal manufacturer remains the same.
• The manufacturing site remains unchanged.
• The authorized Indian agent remains the same.
• The new device belongs to the same overseas manufacturing facility already approved under the existing licence.

Under Rule 34(4)(ii) of the Medical Devices Rules, 2017, a subsequent application for an additional medical device manufactured at the same approved manufacturing site may be submitted along with the prescribed fee and supporting documentation.

When is a Fresh MD-14 Application Required?

A fresh import licence application may be required if:

• There is a new overseas manufacturing site.
• The legal manufacturer changes.
• The Authorized Indian Agent changes.
• The product falls under a different regulatory arrangement requiring separate review.

In such cases, CDSCO may require a completely new MD-14 application instead of a simple endorsement or addition.

Step-by-Step Process to Add a New Medical Device in Existing MD-15 Licence

Step 1: Verify Eligibility

Before initiating the application, confirm that:

• Existing MD-15 licence is valid.
• Manufacturing site is already approved.
• Legal manufacturer is unchanged.
• Device classification is correctly determined (Class A, B, C, or D).

Step 2: Prepare Device Documentation

The applicant must compile the required technical and regulatory documentation as prescribed under the Fourth Schedule of MDR, 2017.

Common documents include:

• Device Master File (DMF)
• Product description
• Intended use statement
• Labeling and IFU
• Free Sale Certificate
• ISO 13485 Certificate
• CE Certificates (if applicable)
• Declaration of Conformity
• Risk Analysis Report
• Clinical Evaluation information (where applicable)

CDSCO may request additional technical data depending on the risk classification and nature of the device.

Step 3: Pay Applicable Government Fee

For adding an additional medical device manufactured at the same approved manufacturing site, CDSCO generally requires payment of the prescribed device registration fee for the additional product.

Since the manufacturing facility has already been licensed, applicants are not usually required to pay manufacturing site registration fees again for the same approved site.

Step 4: Submit Application Through CDSCO SUGAM Portal

The Authorized Indian Agent must:

• Log in to the CDSCO SUGAM Portal.
• Select the relevant import licence amendment/addition option.
• Upload the required technical and legal documents.
• Submit fee payment proof.
• Complete online application submission.

Step 5: CDSCO Review and Query Resolution

CDSCO reviewers evaluate:

• Device classification
• Regulatory status
• Technical documentation
• Safety and performance data
• Compliance with MDR 2017 requirements

Any deficiencies or clarification requests must be responded to within the stipulated timeline.

Step 6: Approval and Licence Endorsement

Upon successful review, CDSCO updates the existing MD-15 licence to include the newly approved medical device.

The importer can then legally import, market, and distribute the added device in India.

Documents Required for Adding a New Medical Device

The exact requirements vary depending on device class and technology. However, the following are typically required:

Administrative Documents

• Cover Letter
• Existing MD-15 Licence Copy
• Authorization Letter
• Power of Attorney (if applicable)
• Fee Payment Receipt

Regulatory Documents

• Free Sale Certificate
• Market Authorization Certificate
• Manufacturing Site Registration
• Regulatory Approval Status

Quality Documents

• ISO 13485 Certificate
• CE Certification (if applicable)
• Declaration of Conformity

Technical Documents

• Device Master File
• Product Catalogue
• Label and IFU
• Risk Management Documentation
• Clinical Evidence (where required)

Common Reasons for CDSCO Queries

Applicants frequently receive CDSCO queries due to:

• Incomplete Device Master File
• Incorrect device classification
• Inconsistent labeling information
• Missing Free Sale Certificate
• Inadequate clinical evidence
• Manufacturing site discrepancies

Early document review by regulatory experts can significantly reduce approval timelines.

Benefits of Adding Devices Under Existing MD-15 Licence

Adding products under an existing import licence offers several advantages:

• Faster approval timelines
• Lower regulatory costs
• Simplified review process
• Reduced documentation burden
• Faster market access for new products

For manufacturers with multiple products from the same manufacturing site, this pathway is significantly more efficient than obtaining a fresh licence.

How MDR Consultants Can Help

At MDR Consultants, we assist medical device manufacturers, importers, and Authorized Indian Agents with:

• CDSCO Device Classification
• MD-14 and MD-15 Applications
• Addition of New Devices to Existing Import Licences
• Device Master File (DMF) Preparation
• Regulatory Gap Assessment
• CDSCO Query Management
• Post-Approval Compliance Support

Our regulatory experts ensure that applications are submitted accurately and in accordance with the latest CDSCO requirements, helping clients achieve faster approvals and uninterrupted market access.

Conclusion

Adding a new medical device to an existing MD-15 Import Licence is a cost-effective and efficient route for expanding a medical device portfolio in India. As long as the legal manufacturer, manufacturing site, and authorized Indian agent remain unchanged, CDSCO allows applicants to seek approval for additional devices through the existing licence framework. Proper documentation, fee submission, and compliance with Medical Devices Rules, 2017 are essential for successful approval.

For expert assistance with MD-15 amendments, additional device registrations, or CDSCO regulatory compliance, MDR Consultants can guide you through every stage of the process.

Last Updated : 11 Jun 2026