- MD-14 endorsement lets you add new devices, models, or sites under an existing MD-15 import license
- Filed as a fresh Form MD-14 application to the Central Licensing Authority — not a new independent license
- Every endorsed device shares the same expiry date as the base import license
- Needs an updated Device Master File plus current regulatory and quality certificates for the new products
Introduction
CDSCO MD-14 endorsement registration is the process importers use to add new medical devices, models, or manufacturing sites to an already-granted Form MD-15 import license, without applying for a brand-new license from scratch. You file a fresh Form MD-14 application along with the existing import license copy, an updated Power of Attorney, current Free Sale/Marketing Authorization Certificates, Quality Certificates, and a revised Device Master File covering the new products.
The Central Licensing Authority reviews the endorsement request, and once approved, the newly added devices share the same validity and expiry date as the original import license.
What Is CDSCO MD-14 Endorsement Registration?
CDSCO MD-14 endorsement registration is how an importer expands the scope of an existing medical device import license without starting the entire licensing process over. Under the Medical Devices Rules, 2017, the import license itself is granted in Form MD-15 after an application is filed in Form MD-14. When the importer or Authorized Indian Agent later wants to bring in additional devices, new models, or manufacturing sites that weren't part of the original approval, they file another Form MD-14 application specifically as an endorsement request against the existing MD-15 license.
This keeps CDSCO's records accurate and transparent — every device legally imported and sold in India is traceable to an approved license, and the endorsement route lets importers grow their product range under one umbrella license instead of managing multiple separate licenses with different validity periods.
Benefits of CDSCO MD-14 Endorsement Registration
- Add new devices or models faster than applying for a fresh standalone import license
- Keep your entire product portfolio under a single MD-15 license with one common expiry and renewal cycle
- Maintain uninterrupted regulatory compliance while expanding your device range in the Indian market
- Avoids duplicate documentation for company-level details already approved under the base license
Who Needs MD-14 Endorsement Registration?
MD-14 endorsement is relevant if you fall into any of these categories:
- An importer or Authorized Indian Agent who already holds a valid MD-15 import license and wants to add a new device or model
- A foreign manufacturer expanding its India product line through its existing Indian agent's import license
- A company adding a new manufacturing site for a device already covered by its MD-15 license
- An importer updating device specifications, variants, or classifications under the same license umbrella
Eligibility for MD-14 Endorsement
- The applicant must already hold a valid, unexpired MD-15 import license
- The new device or model must be manufactured at a site with valid regulatory approval in its country of origin
- The applicant must have a valid Power of Attorney from the manufacturer, authorizing the Indian agent to represent it
- The device must have current Free Sale Certificate/Marketing Authorization and Quality Certificate documentation available
Documents Required for MD-14 Endorsement Registration
Based on CDSCO's checklist for endorsement of additional devices, a complete filing typically includes:
- Fresh Form MD-14 application specifically marked as an endorsement request
- Covering letter explaining the addition being requested
- Fee payment challan for the endorsement application
- Power of Attorney and undertaking from the Authorised Indian Agent, duly authenticated (notarized/apostilled as required)
- Copy of the existing MD-15 import license against which the endorsement is sought
- Free Sale Certificate/Marketing Authorization from the National Regulatory Authority of the country of origin, or from USA, UK, EU, Canada, Japan, or Australia, duly notarized
- Quality Certificate for the actual manufacturing site of the new device
- Updated Device Master File reflecting accurate grouping, specifications, and classification of the new devices
- Any additional technical or labelling documents specific to the new device or variant
Step-by-Step Process for MD-14 Endorsement Registration
- Confirm the existing MD-15 import license is valid and covers the same applicant/Authorised Indian Agent
- Gather the manufacturer's updated Free Sale Certificate/Marketing Authorization and Quality Certificate for the new device
- Update the Device Master File to correctly group and describe the new devices or models
- Fill Form MD-14 online through the SUGAM portal, marking it as an endorsement application against the existing license
- Attach the Power of Attorney, existing license copy, and all supporting regulatory and quality documents
- Pay the prescribed government fee for the endorsement request
- The Central Licensing Authority reviews the application and may raise queries seeking clarification or additional documents
- Respond to any CDSCO queries promptly — the review timeline pauses until a query is answered
- Once satisfied, CDSCO endorses the new devices, models, or sites onto the existing MD-15 import license
Fees for MD-14 Endorsement Registration
| Fee Head | Indicative Details |
| Endorsement application fee | As per Second/Fourth Schedule slab applicable to the device class; verify current rate on SUGAM |
| Per additional device/model endorsed | Fee scales with device risk class (Class A through D); verify current rate on SUGAM |
| Notarization/apostille costs for certificates | Varies by country of origin; not a CDSCO government fee |
CDSCO import license fees vary by device risk classification and are periodically revised. Always confirm the exact current fee slab on the CDSCO/SUGAM portal before submitting an endorsement application.
Timeline: How Long Does MD-14 Endorsement Take?
Endorsement applications are generally faster to process than a fresh import license application, since the base company and Authorised Indian Agent details are already on record with CDSCO. Approval commonly ranges from about 30 to 60 working days for a complete, well-documented request, though this can extend if CDSCO raises queries about the new device's classification, certificates, or Device Master File — the review clock pauses while a query is outstanding and resumes once you respond.
Validity & Renewal for Endorsed Devices
A key point importers often miss: devices added through MD-14 endorsement do not get their own independent validity period. They share the same expiry date as the base MD-15 import license, which is generally valid for five years. So if you endorse additional devices at different points during that five-year cycle, all of them — the original devices and every endorsed addition — expire together when the base license comes up for renewal. It's advisable to apply for renewal of the base import license at least six months before its expiry to avoid any compliance gap.
MD-14 Endorsement vs Fresh Application vs Retention
| Scenario | What You File | Purpose |
| New import license | Form MD-14 (fresh application) | First-time import license for a device not previously covered — granted in Form MD-15 |
| Endorsement | Form MD-14 (marked as endorsement) | Add new devices, models, or sites under an existing MD-15 license |
| Retention | Retention form + fee challan | Keep an existing import license active at renewal, without adding new devices |
Common Reasons MD-14 Endorsement Applications Face Delays
- Free Sale Certificate or Quality Certificate has expired or isn't properly notarized/apostilled
- Device Master File doesn't clearly show how the new device is grouped or classified relative to existing approved devices
- Power of Attorney doesn't cover the specific device or manufacturing site being added
- New device classification doesn't match what's already approved under the base MD-15 license
- Slow response to CDSCO queries, which pauses the review clock and extends the overall timeline
Why Choose Silvereye Certifications
Silvereye Certifications helps importers and Authorized Indian Agents manage the entire MD-14 endorsement lifecycle — from verifying that new devices genuinely fall within scope of the existing MD-15 license, to compiling updated Device Master Files, coordinating notarized Free Sale and Quality Certificates from the country of origin, and tracking CDSCO queries through to approval. Our team stays current with CDSCO and Ministry of Health & Family Welfare updates so your endorsement filing reflects the latest documentation and fee requirements.
Frequently Asked Questions
What is CDSCO MD-14 endorsement registration?
It's the process of adding new medical devices, models, or manufacturing sites to an already-granted MD-15 import license by filing a fresh Form MD-14 application marked as an endorsement request.
Do I need a new import license to add a device?
No. If you already hold a valid MD-15 import license, you can add the new device through endorsement rather than applying for an entirely new license.
What documents are required for MD-14 endorsement?
Key documents include a fresh Form MD-14 application, the existing import license copy, Power of Attorney, updated Free Sale/Marketing Authorization Certificate, Quality Certificate, and an updated Device Master File.
How long does CDSCO MD-14 endorsement take to process?
Endorsement approvals commonly range between 30 and 60 working days for a complete application, though CDSCO queries can extend this timeline.
Does an endorsed device get its own expiry date?
No. Endorsed devices share the same expiry date as the base MD-15 import license, so all endorsed products expire together with the original license.
Who can apply for MD-14 endorsement?
An importer or Authorised Indian Agent who already holds a valid MD-15 import license can apply to endorse additional devices, models, or manufacturing sites.
What is the fee for MD-14 endorsement?
Fees vary by the device's risk classification (Class A through D) under the applicable CDSCO fee schedule — always confirm the current rate on the SUGAM portal.
What happens if my import license expires before I renew it?
Letting the base MD-15 license lapse can interrupt your legal right to import and sell the covered devices, so applying for renewal at least six months before expiry is recommended.
Can I endorse a device from a different manufacturing site than my original license?
Yes, provided the new site has valid regulatory approval and a Quality Certificate, and the Device Master File is updated to reflect the new manufacturing location.
What's the difference between endorsement and retention of an import license?
Endorsement adds new devices, models, or sites to an existing license. Retention simply keeps an existing license active without adding anything new.
