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EPR Annual Compliance
Introduction
A CDSCO MD-14 endorsement lets an importer add new medical devices, models, or variants to an already-granted MD-15 import license, instead of filing a completely fresh application. It is submitted on the same Form MD-14, marked as an endorsement application, and references the existing import license number.
Since the Authorized Indian Agent's constitution, Power of Attorney, and base regulatory approvals are typically already on record, the endorsement checklist is lighter than a fresh application — though a full Device Master File is still required for each new device being added. Endorsement approvals commonly take 30 to 60 working days for straightforward additions.
What Is a CDSCO MD-14 Endorsement?
When an importer already holds a valid import license in Form MD-15, and wants to bring in additional medical devices, new models, or variants under that same license, they don't need to start the import license process over again. Instead, they file what CDSCO's own checklist calls an "Endorsement application in Form MD-14" — the same form used for a fresh application, but submitted to add products to an existing license rather than create a new one.
This distinction matters because the endorsement route is materially lighter on documentation. Since your Authorized Indian Agent's constitution, base regulatory certificates, and Power of Attorney are typically already verified and on file with CDSCO from your original MD-14/MD-15 approval, the endorsement checklist skips re-submitting those and focuses on what's actually new: the device itself.
Fresh Application vs Endorsement vs Retention: What's the Difference?
CDSCO's own checklist for Form MD-15 recognises three distinct scenarios under the same import license framework. Here's how they compare:
| Scenario |
What It's For |
Key Distinguishing Requirement |
| Fresh MD-14 application |
First-time import license for a new applicant/product line |
Full agent constitution, POA, and base regulatory certificates required |
| Endorsement (MD-14) |
Adding new devices/models under an existing import license |
References the existing import license; agent-level documents largely already on file |
| Retention (MD-15) |
Keeping the license active every 5 years |
Undertaking of no major DMF/PMF change, plus post-market surveillance data |
All three fall under the same Form MD-14/MD-15 framework, but each is triggered by a different business need: launching for the first time, expanding your product range, or simply keeping an existing license alive.
Why File an Endorsement Instead of a Fresh Application?
Avoids duplicating agent-level paperwork — constitution details, Power of Attorney, and Wholesale/Manufacturing license copies are typically already validated with CDSCO.
Keeps all your imported devices consolidated under one base import license number, which simplifies compliance tracking and renewal.
Generally faster than a fresh application, since CDSCO is reviewing an addition to a known, already-approved file rather than onboarding a new applicant.
Supports smoother portfolio expansion for importers adding new models, variants, or related device categories from the same manufacturer.
Reduces the risk of inconsistent licensing records across multiple import licenses for the same agent or manufacturer.
Who Can Apply for an MD-14 Endorsement?
Authorized Indian Agents who already hold a valid import license in Form MD-15 and want to add new devices under it.
Importers expand their approved product scope with new models, variants, or accessories from the same overseas manufacturer.
Manufacturers adding devices that fall within the same regulatory and quality framework already approved under the base license.
If there's no existing MD-15 import license to endorse — for example, you're bringing in a device from a manufacturer you've never imported before, or your current license has lapsed — you would need to file a fresh MD-14 application instead of an endorsement.
Documents Required for MD-14 Endorsement
Based on CDSCO's own published checklist for endorsement applications under Form MD-14, the following documents are typically required:
Covering letter explaining the purpose of the endorsement and listing the new devices being added.
Duly completed Application (Form MD-14), marked as an endorsement.
Fee challan for the endorsement application.
Power of Attorney with undertaking from the Authorized Agent, as specified in Part I of the Fourth Schedule.
Copy of the existing import license for which the endorsement is being applied.
Regulatory certificate — a 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 — Quality Management System certificate, Full Quality Assurance/CE certificates as applicable, and a declaration of conformity from the manufacturer.
Undertaking from the overseas manufacturer confirming there is no major change in the existing Plant Master File — if there is a change, updated Appendix I information must be submitted.
Device Master File for the new device(s), covering executive summary, device description, product specifications, labelling, risk analysis, verification and validation, and other Appendix II particulars applicable to that device.
Any other additional documents CDSCO may require for the specific device category.
Step-by-Step Process: Filing an MD-14 Endorsement Application
Confirm your existing MD-15 import license is active and identify exactly which new devices, models, or variants you want to add.
Prepare a complete Device Master File for each new device, covering description, specifications, labelling, risk analysis, and validation data as applicable to its risk class.
Obtain an updated regulatory certificate (Free Sale Certificate/Marketing Authorization) covering the new device, if not already included in your base approval.
Secure the overseas manufacturer's undertaking confirming there is no major change to the existing Plant Master File — or prepare updated Appendix I details if there is.
Log into the SUGAM portal, select the endorsement application option under Form MD-14, and reference your existing import license number.
Upload the covering letter, Power of Attorney, quality certificates, Device Master File, and other required documents, and pay the endorsement fee.
Submit the application for CDSCO's scrutiny.
Respond promptly to any deficiency memo or query CDSCO raises during review.
On satisfactory review, CDSCO endorses the new device(s) onto your existing MD-15 import license.
CDSCO MD-14 Endorsement Fees
Endorsement fees are charged under the same Second Schedule of the Medical Devices Rules, 2017 that governs fresh import license fees, and vary based on the device's risk classification (Class A, B, C, or D), the number of distinct devices or models being added, and how they're grouped under CDSCO's medical device grouping guidelines.
Verify before you file
Because endorsement fees depend on device classification, grouping, and the number of models added — and government fee notifications are revised periodically — always confirm the exact fee for your specific device list on the SUGAM portal or with CDSCO before submitting payment. Avoid relying on a flat number quoted elsewhere, since it may not reflect your device's classification or current notification.
Validity and Retention After Endorsement
An endorsed device does not get its own separate expiry date. It becomes part of your existing base import license and follows that license's five-year retention cycle — the same cycle that applies to the devices originally approved under your MD-15 license.
The base import license (and everything endorsed onto it) remains valid, subject to payment of the retention fee before completion every five years from the date the base license was issued.
At retention time, you'll need to submit an undertaking that there's no major change in the Device Master File or Plant Master File for all endorsed products, along with post-marketing surveillance data covering the preceding years.
If a device is later discontinued, it can be formally deleted from the import license at the time of retention, along with the reason for removal.
Any change in the Power of Attorney or firm constitution since the last approval must be disclosed and updated at the time of retention.
MD-14 Endorsement Timeline at a Glance
| Stage |
Typical Timeframe |
| Device Master File & documentation preparation |
Varies by device complexity and readiness |
| Endorsement application submission via SUGAM |
After documentation is complete |
| CDSCO scrutiny and query resolution |
Commonly cited as 30-60 working days for straightforward additions |
| Endorsement onto existing MD-15 license |
On satisfactory review |
| Retention fee due (whole license, including endorsed devices) |
Before completion of every 5 years from the base license's issue date |
Verify before you file
The 30-60 working day range is commonly cited by regulatory consultants for routine endorsements, but CDSCO does not publish a fixed statutory timeline for endorsement applications specifically. Complex devices (Class C/D, new technology, or missing documentation) can take considerably longer — build in buffer time accordingly.
Why Choose Silvereye Certifications For Getting Your MD-14 Endorsement
An MD-14 endorsement is one of the most practical tools for importers scaling their medical device portfolio in India — but it only stays practical if the new device's Device Master File, regulatory certificates, and manufacturer undertakings are prepared with the same rigour as a fresh application. Mismatched model numbers, an outdated Free Sale Certificate, or a poorly worded Plant Master File undertaking are common, avoidable reasons endorsements get stuck in query cycles.
Silvereye Certifications supports medical device importers end-to-end with MD-14 endorsement filings — from confirming eligibility against your existing MD-15 license, to preparing the Device Master File and manufacturer undertakings, and tracking your base license's five-year retention cycle so every endorsed device stays compliant.
Next step
Looking to add new devices to your existing CDSCO import license? Talk to Silvereye Certifications for a documentation review and end-to-end MD-14 endorsement filing support before you submit your application.
Frequently Asked Questions: CDSCO MD-14 Endorsement
It's an application, filed on the same Form MD-14, used to add new medical devices, models, or variants to an import license you already hold in Form MD-15 — instead of applying for a completely new import license.
A fresh application creates a brand-new import license and requires full agent constitution, Power of Attorney, and base regulatory documents. An endorsement references your existing license number and skips re-submitting most agent-level documents, focusing mainly on the new device's own documentation.
Any Authorized Indian Agent or importer who already holds a valid MD-15 import license and wants to add new devices, models, or variants under that same license.
Key documents include the covering letter, Form MD-14 application, Power of Attorney, a copy of the existing import license, updated regulatory and quality certificates, a manufacturer's undertaking on the Plant Master File, and a full Device Master File for the new device.
Yes. Even though most agent-level paperwork is already on file, CDSCO still requires a complete Device Master File — covering description, specifications, labelling, risk analysis, and validation data — for every new device being endorsed.
Routine endorsements are commonly cited as taking around 30 to 60 working days, though CDSCO doesn't publish a fixed statutory timeline for endorsements specifically. Complex devices or incomplete documentation can extend this considerably.
Endorsement fees fall under the same Second Schedule that governs import license fees, and vary by device risk classification and the number of devices or models added. Always confirm the exact fee for your device list on the SUGAM portal before payment.
No. An endorsed device becomes part of your base import license and follows that license's existing five-year retention cycle — it doesn't carry a separate validity period.
You cannot simply submit a "no major change" undertaking in that case. Instead, you'll need to submit updated Plant Master File information as specified in Appendix I of the Fourth Schedule, reflecting the actual current state of the manufacturing site.
Endorsements are generally used to expand the product scope tied to your existing import license and its underlying manufacturer/agent relationship. Devices from an entirely different, previously unapproved manufacturer typically require their own fresh MD-14 application rather than an endorsement.
