CDSCO MD-3 Endorsement
Introduction
A CDSCO MD-3 endorsement lets a manufacturer add new Class A or Class B medical devices, models, or variants to an already-granted MD-5 manufacturing license, instead of filing a completely fresh application. It is submitted on the same Form MD-3, marked as an endorsement, and references the existing manufacturing license number.
Since the applicant's constitution and site details are usually already on record with the State Licensing Authority, the endorsement checklist skips re-verifying those and focuses on a Device Master File for the new device.
What Is a CDSCO MD-3 Endorsement?
Form MD-3 is the application a manufacturer files with the State Licensing Authority (SLA) to get a manufacturing license for Class A or Class B medical devices — low and low-to-moderate risk devices such as thermometers, surgical gloves, or blood pressure monitors. Once approved, the license itself is granted in Form MD-5.
When a manufacturer who already holds an MD-5 license wants to add a new device, model, or variant under that same license — rather than apply from scratch — they file what's officially recognised as an endorsement application in Form MD-3. It's the same form, but it references your existing manufacturing license number and is reviewed as an addition to a file the SLA already has, not as a new applicant.
Fresh Application vs Endorsement vs Retention: What's the Difference?
CDSCO's published checklists for the MD-3/MD-5 framework recognise three distinct scenarios, mirroring the same structure used across its other manufacturing and import license forms:
| Scenario |
What It's For |
Key Distinguishing Requirement |
| Fresh MD-3 application |
First-time Class A/B manufacturing license for a new applicant or site |
Full constitution details, site ownership/tenancy proof, and complete Plant Master File required |
| Endorsement (MD-3) |
Adding new Class A/B devices/models under an existing MD-5 license |
References the existing license; Plant Master File requires only an undertaking of "no major change" unless the site has changed |
| Retention (MD-5) |
Keeping the license active, typically every 5 years |
Undertaking of no major DMF/PMF change, list of any deleted devices, and current technical staff details |
All three fall under the same MD-3/MD-5 framework, but each responds to a different situation: launching manufacturing for the first time, expanding your approved device range, or simply keeping an existing license active.
Why File an Endorsement Instead of a Fresh Application?
Avoids duplicating paperwork — constitution details, site ownership proof, and core Plant Master File information are typically already verified and on record with the SLA.
Keeps all your Class A/B devices consolidated under one base manufacturing license number, simplifying compliance tracking.
Generally more efficient than a fresh application, since the SLA is reviewing an addition to a known, already-licensed file rather than a brand-new applicant.
Supports smoother portfolio growth for manufacturers adding new models, variants, or related device categories at the same facility.
Reduces the risk of inconsistent or duplicate manufacturing licenses for the same site and manufacturer.
Who Can Apply for an MD-3 Endorsement?
Manufacturers who already hold a valid MD-5 manufacturing license and want to add new Class A or Class B devices, models, or variants at the same facility.
Manufacturers expanding their approved product range within the same risk class and manufacturing site.
Businesses introducing new accessories or variants of an already-approved device under the same license.
If there's no existing MD-5 license to endorse — for example, this is your first Class A/B device, or you're setting up an entirely new manufacturing site — you would file a fresh MD-3 application instead of an endorsement. And if you don't own the manufacturing premises at all, you'd need Form MD-4 for a loan license instead.
Documents Required for MD-3 Endorsement
Based on CDSCO's published checklist structure for endorsement applications under this form family, the following documents are typically required for an MD-3 endorsement:
Covering letter explaining the purpose of the endorsement and listing the new device(s) being added.
Duly completed Application (Form MD-3), marked as an endorsement.
Fee challan for the endorsement application.
Copy of the existing MD-5 manufacturing license under which the endorsement is being applied.
Plant Master File — with an undertaking from the manufacturer that there is no major change to the existing Plant Master File; if there has been a change, updated site information must be submitted instead.
Undertaking that the manufacturing site remains in compliance with Fifth Schedule Quality Management System requirements for the new device being added.
Device Master File for the new device — executive summary, device description, product specification, labelling, risk analysis, verification and validation data, and other particulars applicable to that device's risk class.
Test license copy (Form MD-13), if quality control data for the new device was generated under one.
Any other additional documents the State Licensing Authority may require for the specific device category.
Step-by-Step Process: Filing an MD-3 Endorsement Application
Confirm your existing MD-5 manufacturing license is active and identify exactly which new Class A/B device(s), models, or variants you want to add.
Prepare a complete Device Master File for the new device, covering description, specifications, labelling, risk analysis, and validation data appropriate to its risk class.
Confirm whether your manufacturing site has changed since your original approval — if not, prepare the "no major change" undertaking for the Plant Master File; if it has, prepare updated site information.
Log into the SUGAM/state medical device portal, select the endorsement option under Form MD-3, and reference your existing MD-5 license number.
Upload the covering letter, Device Master File, Plant Master File undertaking, QMS compliance undertaking, and other required documents, and pay the endorsement fee.
Submit the application to the concerned State Licensing Authority for scrutiny.
For Class B devices, be prepared for a site audit as part of the endorsement review — Class A devices typically don't require a fresh site audit.
Respond promptly to any deficiency memo or query the SLA raises during review.
On satisfactory review, the State Licensing Authority endorses the new device(s) onto your existing MD-5 manufacturing license.
CDSCO MD-3 Endorsement Fees
Endorsement fees fall under the same Second Schedule of the Medical Devices Rules, 2017 that governs fresh Class A/B manufacturing license fees, and are commonly cited as follows:
| Fee Component |
Typical Fee |
| Manufacturing license fee (per manufacturing site) |
Rs. 5,000 |
| Fee per distinct Class A/B medical device |
Rs. 500 |
| Retention fee (before completion of every 5 years) |
As per Second Schedule; keeps a perpetual license active |
Verify before you file
These figures are the fees consistently cited for Class A/B manufacturing licenses under the Second Schedule. Endorsement fees are typically calculated per additional device/model being added. Since government fee notifications are revised periodically, confirm the current amount on the SUGAM portal before making payment.
Validity, Retention, and Renewal
A manufacturing license granted in Form MD-5 — including any devices endorsed onto it — does not carry a fixed expiry date under the Medical Devices Rules, 2017 framework. It remains valid, subject to payment of the retention fee before completion of every five-year period from the date of issue, unless suspended or cancelled by the State Licensing Authority.
There's no traditional "renewal" filing — a retention fee paid every 5 years keeps the license (and everything endorsed onto it) active.
At retention time, you'll typically need to confirm there's no major change to the Device Master File or Plant Master File, and provide post-marketing surveillance data for the preceding years.
If a device is discontinued, it can be formally deleted from the license at the time of retention, along with the reason for removal.
Failure to pay the retention fee on time can result in the license being suspended or cancelled by the State Licensing Authority.
MD-3 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 |
| Site audit (Class B devices only) |
As scheduled by the State Licensing Authority |
| SLA scrutiny and query resolution |
Statutory decision window of 45 days is commonly cited; practical timelines vary by state and device class |
| Endorsement onto existing MD-5 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 |
Why Choose Silvereye Certifications For Getting Your MD-3 Endorsement
An MD-3 endorsement is a practical way to grow your Class A/B device portfolio without duplicating paperwork you've already submitted — but it only stays efficient if the new device's Device Master File and Plant Master File undertaking are prepared with the same rigour as a fresh application. Confusing this route with import license endorsement, or submitting a "no major change" undertaking when your site has actually changed, are avoidable reasons applications get stuck in query cycles.
Silvereye Certifications supports medical device manufacturers end-to-end with MD-3 endorsement filings — from confirming eligibility against your existing MD-5 license, to preparing the Device Master File and Plant Master File documentation, coordinating any required site audit, and tracking your license's retention cycle so every endorsed device stays compliant.
Next step
Looking to add new Class A or Class B devices to your existing CDSCO manufacturing license? Talk to Silvereye Certifications for a documentation review and end-to-end MD-3 endorsement filing support before you submit your application.
Frequently Asked Questions: CDSCO MD-3 Endorsement
It's an application, filed on the same Form MD-3, used to add new Class A or Class B medical devices, models, or variants to a manufacturing license you already hold in Form MD-5 — instead of applying for a completely new manufacturing license.
No. MD-3 is specifically part of CDSCO's manufacturing license framework for Class A and Class B devices, granted as MD-5. Import licenses use a separate form pair — MD-14 for the application and MD-15 for the grant. Some online guides describe MD-3 endorsement as relating to import licenses, but that's inconsistent with CDSCO's own published regulatory pathway.
A fresh application creates a brand-new manufacturing license and requires full constitution details, site ownership proof, and a complete Plant Master File. An endorsement references your existing MD-5 license and mainly requires an undertaking that the site hasn't materially changed, plus a full Device Master File for the new device.
Any manufacturer who already holds a valid MD-5 manufacturing license for Class A or Class B devices and wants to add new devices, models, or variants at the same manufacturing site.
Key documents include the covering letter, Form MD-3 application marked as endorsement, a copy of your existing MD-5 license, a Plant Master File undertaking, a Quality Management System compliance undertaking, and a full Device Master File for the new device.
Yes. Even though site and constitution details are usually already on file, CDSCO's endorsement framework still requires a complete Device Master File — covering description, specifications, labelling, risk analysis, and validation data — for each new device being endorsed.
It depends on the device class. Class B devices typically require a site audit as part of the endorsement review. Class A devices generally don't require a fresh site audit, consistent with how Class A applications are handled under the Medical Devices Rules, 2017.
Endorsement fees fall under the same Second Schedule that governs Class A/B manufacturing license fees, commonly cited as around Rs. 5,000 per site and Rs. 500 per distinct device. Confirm the exact fee for your device on the SUGAM portal before payment.
No. An endorsed device becomes part of your base MD-5 manufacturing license and follows that license's existing retention cycle — it doesn't carry a separate validity period.
You can't simply submit a "no major change" undertaking in that case. You'll need to submit updated Plant Master File information reflecting the actual current state of the manufacturing site.
