- An Indian authorized agent files Form MD-14 on CDSCO's portal. A foreign manufacturer cannot apply alone.
- CDSCO reviews the dossier, raises queries, and then issues the MD-15 import license.
- Government fees are in USD and depend on device class, number of sites and number of devices.
- The license has no fixed expiry, but a retention fee is due every five years.
How to Get an MD-15 License in India?
To understand how to get an MD-15 license in India, the process starts with the Indian authorized agent submitting Form MD-14 through the applicable CDSCO online system. The application is supported by documents such as the Power of Attorney, Free Sale Certificate/Marketing Authorization, applicable quality certificates, Plant Master File, Device Master File and the prescribed Second Schedule fee.
CDSCO reviews the application and may raise deficiency or clarification queries before making its decision. If the application satisfies the applicable requirements, CDSCO grants the import license in Form MD-15.
There is no single guaranteed processing time for every application. The actual timeline depends on the device class, completeness of the dossier, queries, technical review and any applicable inspection. The MD-15 license is perpetually valid, subject to the applicable five-year retention requirements and continued compliance.
Is MD-15 the Right License for Your Medical Device?
Before starting the application, confirm that MD-14/MD-15 Registration is the correct regulatory route for your product.
| Your Situation | Applicable Route |
|---|---|
| Importing a finished medical device or IVD for sale/distribution | Apply in Form MD-14 for an import license in Form MD-15, where applicable |
| Importing devices for clinical investigation, testing or evaluation | Check the applicable MD-16/MD-17 route |
| Manufacturing the device in India | Follow the applicable medical device manufacturing licence route |
| Class A non-sterile and non-measuring device | An applicable registration/exemption route may apply instead of the standard MD-14/MD-15 route |
Important: Always confirm the device's classification and regulatory pathway before paying the import-licence fee.
Who Can Apply for an MD-15 License?
The overseas manufacturer does not simply apply as an Indian importer on its own. The application is made through an eligible Indian authorized agent appointed by the overseas manufacturer.
The medical-device import licensing requirements were implemented in phases, with Class A and B devices coming under the licensing regime from 1 October 2022 and Class C and D devices from 1 October 2023.
In general:
- Indian authorized agent: The overseas manufacturer appoints an eligible Indian authorized agent through a Power of Attorney.
- Agent's license/registration: The agent must have the applicable wholesale license, manufacturing license or Form MD-42 registration certificate, depending on the regulatory pathway.
- Overseas manufacturer: The manufacturer must provide the applicable regulatory, quality and technical documentation required by CDSCO.
- Medical device: The product must be correctly classified as Class A, B, C or D, and identified as an IVD or non-IVD, as applicable.
Why Is an MD-15 License Important?
1. Regulatory Market Access
Where an import license is required, MD-15 provides the applicable regulatory authorization for importing the medical device for sale or distribution in India.
2. Business and Tender Requirements
Hospitals, distributors, procurement teams and tender authorities may request evidence of the product's CDSCO regulatory status.
3. Perpetual Validity
An MD-15 license does not have a simple five-year expiry. It remains perpetually valid, subject to the required retention fee and ongoing compliance.
4. Clear Regulatory Link
The license connects the overseas manufacturer, manufacturing site, Indian authorized agent and approved devices within the import-licensing framework.
What Documents Do You Need Before Applying?
This is a short overview. For the complete document-by-document checklist, refer to the detailed MD-14 and MD-15 Documents Required section.
| Group | Main Documents |
|---|---|
| Indian authorised agent | Form MD-14, Power of Attorney and undertaking, applicable agent licence/MD-42 registration and fee payment proof |
| Overseas manufacturer | Free Sale Certificate/Marketing Authorization, manufacturing-site documents, applicable QMS/ISO 13485 certificate, CE or quality certificates where applicable, Declaration of Conformity and Plant Master File |
| Product/technical file | Device Master File, device/model list, labels and IFU, applicable clinical/performance evidence, sterilisation and shelf-life information |
| Import requirements | IEC and applicable customs/import documentation |
The exact documents can vary according to the device class, IVD status and specific CDSCO requirements.
How to Get an MD-15 License: Step-by-Step Process
1. Confirm the device classification
First, determine the device's risk class and whether it is an IVD or non-IVD. Also check whether any Class A exemption applies.
The classification can affect the regulatory pathway, documentation and applicable government fee.
2. Appoint an Indian authorized agent
The overseas manufacturer appoints an eligible Indian authorized agent and executes the required Power of Attorney and undertaking.
3. Authenticate the Power of Attorney
Complete the authentication required under the applicable Medical Devices Rules and Fourth Schedule. Start this step early because authentication and legalisation can take additional time.
4. Collect the manufacturer's regulatory documents
Prepare the applicable Free Sale Certificate/Marketing Authorization, manufacturing-site documents, QMS certificates, CE or other regulatory certificates and Declaration of Conformity.
5. Prepare the PMF and DMF
Prepare the Plant Master File (PMF) for the relevant manufacturing site and the Device Master File (DMF) for the medical device.
Make sure the manufacturer name, site address, product name and model numbers are consistent across all documents.
6. Calculate the applicable government fee
Calculate the fee using the applicable Second Schedule based on the relevant device category, manufacturing site and number of distinct devices.
Do not add a separate brand fee unless the applicable current fee provision specifically requires it.
7. Submit Form MD-14
Complete the applicable CDSCO online application, upload the required documents and pay the prescribed government fee.
Because CDSCO's online systems and portal arrangements can change, verify the currently active submission portal before filing.
8. Respond to CDSCO queries
CDSCO may issue deficiency or clarification queries during review. Respond to every point with clear supporting documents and ensure that the response remains consistent with the original application.
9. Receive Form MD-15
Once CDSCO approves the application, Form MD-15 is issued as the import licence.
Before arranging commercial shipments, carefully check the license for the manufacturer name, manufacturing-site details, authorized agent and approved device information.
How to Choose the Right Indian Authorized Agent
The Indian authorized agent plays an important role in the MD-14 and MD-15 process and is identified in the import-licensing documentation. Choose an agent carefully.
Look for an agent who:
- Holds the applicable wholesale licence, manufacturing licence or MD-42 registration required for your device and activity.
- Has experience with CDSCO medical device import applications and can explain how they handle deficiency or query letters.
- Clearly agrees in writing on fees, document custody, responsibilities and communication.
- Is available to respond quickly when CDSCO raises a query or requests additional information.
- Explains the process for changing the authorised agent if the relationship ends.
Before signing an agreement, understand the exit terms and regulatory process for changing the authorised agent.
What Are the MD-15 License Fees in India in 2026?
Government fees for an MD-15 import license are prescribed under the Second Schedule of the Medical Devices Rules, 2017 and are specified in US dollars.
The fee structure includes an applicable overseas manufacturing-site fee and device fee.
| Device Category | Fee per Overseas Site | Fee per Distinct Device |
|---|---|---|
| Class A – Non-IVD where MD-14/MD-15 applies | USD 1,000 | USD 50 |
| Class B – Non-IVD | USD 2,000 | USD 1,000 |
| Class C or D – Non-IVD | USD 3,000 | USD 1,500 |
| Class C or D – IVD | USD 3,000 | USD 500 |
Important: Certain Class A non-sterile and non-measuring devices are exempt from the standard MD-14/MD-15 licensing route, subject to the applicable registration requirements.
Also, avoid describing the fee as a separate charge for every brand unless the specific current fee provision applies that way. The safer description is “each distinct medical device” under the applicable fee schedule.
What Other Costs Should You Consider?
Government fees are only one part of the overall registration cost. You may also have expenses for:
- Notarisation, apostille or embassy authentication
- Preparation or updating of the Plant Master File and Device Master File
- Translation of documents where required
- Regulatory consultant or authorised-agent fees
- Courier, legal and document-processing expenses
For IVDs, check the exact class-specific fee in the current Second Schedule before payment.
How Long Does It Take to Get an MD-15 License?
There is no guaranteed 3-, 6- or 12-month approval period for every MD-15 application. The actual timeline depends on the device class, completeness of the dossier, CDSCO queries, technical review and whether an inspection or additional information is required.
Instead of treating consultant-reported ranges as official timelines, use the applicable regulatory timeframe and your individual application status as the reference point.
| Stage | What Can Affect the Timeline? |
|---|---|
| Application review | Completeness and quality of the initial dossier |
| Technical assessment | Device class and complexity |
| CDSCO queries | Number and complexity of deficiency letters |
| Site inspection, where applicable | Scheduling and inspection requirements |
| Applicant response | Speed and completeness of responses |
| Final decision | Completion of all applicable regulatory requirements |
How Can You Reduce Delays?
- Submit a complete and internally consistent dossier.
- Check every manufacturer name, site address and model number before submission.
- Respond to CDSCO queries within the specified deadline.
- Provide a complete response addressing every query point.
- Avoid unnecessary changes to the application while it is under review.
What Should You Do After Receiving MD-15?
Getting the licence is not the end of your regulatory responsibilities. After receiving Form MD-15:
- Check the licence carefully and report any discrepancy through the applicable CDSCO process.
- Make sure your labelling complies with the applicable Medical Devices Rules, including the required import-licence information where applicable.
- Confirm your IEC and customs arrangements before the first commercial shipment.
- Add the five-year retention date to your regulatory calendar.
- Plan regulatory submissions early if you intend to add new devices, manufacturing sites or other changes.
- Maintain appropriate post-market surveillance, complaint handling and vigilance records as applicable.
Is an MD-15 License Valid for Five Years?
No. MD-15 does not have a simple five-year expiry.
Under the current framework, the import licence remains perpetually valid, subject to payment of the applicable retention fee at the prescribed five-year intervals and continued compliance.
| Point | What It Means |
|---|---|
| Validity | Perpetual, subject to the applicable rules |
| Retention | Retention fee is payable at the prescribed five-year intervals |
| Retention fee amount | Determined under the applicable Second Schedule |
| Late payment | Follow the current Medical Devices Rules and CDSCO instructions applicable at the time |
| Non-payment | Can result in regulatory consequences, including cancellation where applicable |
| Changes after grant | Additional devices, sites or changes to licence details may require applicable endorsement, amendment or fresh application |
What Mistakes Can Delay or Block an MD-15 License?
Common problems include:
- Choosing an Indian authorized agent whose license or registration does not cover the applicable activity.
- Submitting a Power of Attorney that does not meet the required authentication requirements.
- Providing an expired or inconsistent Free Sale Certificate/Marketing Authorisation.
- Using different manufacturer names, addresses or model numbers across documents.
- Calculating the wrong government fee.
- Submitting an incomplete or poorly organised Device Master File or Plant Master File.
- Missing required clinical, performance, quality or regulatory evidence.
- Treating an MD-16/MD-17 test or evaluation import route as a shortcut for commercial imports. It is a different regulatory pathway and should not be used as a substitute for the required MD-14/MD-15 licence.
Conclusion
Getting an MD-15 Import License is an important step for overseas manufacturers and Indian importers who want to legally import regulated medical devices into India. The process starts with the right device classification, appointment of an eligible Indian Authorized Agent, preparation of the MD-14 application, and submission of the required technical and regulatory documents to CDSCO.
A complete and accurate application can help avoid queries, delays, and compliance issues. Since requirements can vary based on the device class, product type, manufacturing site, and applicable pathway, it is important to review the latest CDSCO requirements before applying.
With the right documentation and regulatory support, businesses can make the MD-14 to MD-15 licensing process more organized and manageable.
Why Choose Silvereye Certifications for MD-14 & MD-15?
Silvereye Certifications helps medical device manufacturers and importers manage the CDSCO MD-14 and MD-15 licensing process from application preparation to post-licence compliance.
What We Help With
- Device Classification Support: Help determine the applicable medical device classification and regulatory pathway.
- Documentation Support: Assistance with preparing and reviewing MD-14, Power of Attorney, FSC/Marketing Authorisation, PMF, DMF, labelling and other required documents.
- Application Preparation: Support in compiling and submitting the application to CDSCO through the applicable process.
- Query Management: Assistance in responding to CDSCO queries and clarification requests.
- Authorised Agent Support: Guidance on the requirements for appointing and maintaining an Indian Authorised Agent.
- Post-Licence Compliance: Support with applicable retention, amendments, endorsements and other regulatory requirements.
- End-to-End Guidance: A structured approach to help reduce documentation errors and make the licensing process easier to manage.
Start Your MD-15 Licensing Process
If you are planning to import medical devices into India, Silvereye Certifications can help you understand the applicable requirements and prepare your application correctly.
Contact Silvereye Certifications for professional assistance with your MD-14 and MD-15 Import Licence application.
Frequently Asked Questions
How do I get an MD-15 license in India?
Your Indian authorised agent files Form MD-14 on the CDSCO portal with the required documents and fee. After review and query resolution, CDSCO issues the license in Form MD-15.
Can I apply for MD-15 myself as a foreign manufacturer?
No. The application must be made through an Indian authorised agent appointed by a Power of Attorney.
Where do I apply for MD-14?
Online on the CDSCO medical device portal, historically SUGAM and now moving to the National Single Window System.
How much does an MD-15 license cost?
Government fees range from USD 1,000 per site plus USD 50 per device for Class A to USD 3,000 per site plus USD 1,500 per device for Class C and D. Professional costs are extra.
How long does it take to get an MD-15 license?
Consultants report roughly 3 to 9 months for Class A and B and 6 to 12 months or more for Class D. There is no fixed guarantee.
Is MD-15 valid for life?
It has no fixed expiry, but it stays valid only if the retention fee is paid every five years.
What happens if I forget the retention fee?
A late fee of 2% per month applies for a limited period, after which the license can be cancelled.
Do I need a consultant to get MD-15?
It is not mandatory, but first-time applicants often use one to avoid avoidable queries.
Can I import samples before I get MD-15?
Limited quantities for testing or clinical investigation can be imported under MD-16 and MD-17, but not for commercial sale.
Can one MD-15 cover several devices?
Yes, you can list multiple devices, but each distinct device and each brand carries its own fee.
Can I change my Indian agent later?
Yes, but it needs an amendment with a fresh Power of Attorney and CDSCO approval.
Does my device label need the license number?
Yes. The Medical Devices Rules require the import license number on the label.
