- Form MD-4 applies only to Class A and Class B medical devices — low to moderate risk category
- Filed with the State Licensing Authority (SLA), not the central CDSCO office
- Approval is issued as a separate document — Form MD-6 — once the application clears review
- No factory needed — you manufacture at a partner's already-licensed site under a signed agreement
Introduction
Form MD-4 is the CDSCO application used to request a loan license for manufacturing Class A or Class B medical devices at a facility you don't own. You file it online through the SUGAM portal to the State Licensing Authority, along with a signed agreement with your host manufacturer, the Device Master File, Site Master File, and a copy of the host's valid manufacturing license. Once the State Licensing Authority reviews the documents and clears the facility audit, it grants the loan license in Form MD-6. Processing commonly takes around 45 days for a complete, error-free application.
What Is CDSCO Medical Device Loan License MD-4?
Form MD-4 is the official application prescribed under the Medical Devices Rules, 2017, for a company seeking a loan license to manufacture Class A or Class B medical devices for sale or distribution. Rather than applying for a manufacturing license against a factory it owns, the applicant (referred to as the loan licensee) applies to use the licensed premises of another manufacturer — the host site — that already holds a valid manufacturing license, Form MD-5, for the same category of device.
The State Licensing Authority (SLA) of the relevant state reviews Form MD-4, since Class A and Class B devices are considered lower risk under Schedule I of the Medical Devices Rules, 2017 — devices such as bandages, stethoscopes, thermometers, blood pressure monitors, catheters, and syringes fall in this bracket. Once the SLA is satisfied that the application, the host facility's compliance record, and the manufacturing agreement meet requirements, it issues the loan license in a separate form — Form MD-6.
Benefits of Applying for a Loan License via Form MD-4
- Launch a medical device brand without the capital cost of setting up a manufacturing plant
- Faster route to market compared to building and validating an in-house facility from scratch
- Lets design-and-marketing-focused companies rely on an already GMP-compliant host facility
- Applicable across the full range of Class A and Class B devices under Schedule I
Who Is Eligible to File Form MD-4?
Form MD-4 can be filed by any of the following:
- A registered Indian company, LLP, partnership, or proprietorship with a valid SUGAM portal account
- A brand owner or importer that has identified a host facility already licensed (Form MD-5) for the same Class A/B device category
- An existing manufacturer wanting to add a new Class A/B device to its portfolio through a partner facility instead of expanding its own line
The device itself must correctly fall under Class A or Class B as per CDSCO's device classification list — filing under the wrong risk class is one of the most common reasons applications are sent back for correction.
Required Documents For CDSCO Medical Device Loan License MD-4
Based on the CDSCO checklist framework for loan license applications, a complete MD-4 filing typically includes:
- Covering letter addressed to the State Licensing Authority
- Duly filled Form MD-4 application
- Fee payment challan / proof of government fee paid
- Constitution documents of the applicant firm (incorporation certificate, partnership deed, or equivalent)
- Establishment, site ownership, or tenancy agreement of the applicant's registered office
- Signed agreement between the applicant and the host manufacturer whose facility will be used
- Copy of the host manufacturer's valid license (Form MD-5) showing the same device is already covered
- Device Master File — device name, model, intended use, shelf life, storage conditions
- Site Master File / Plant Master File of the host facility
- Undertaking from the host manufacturer confirming no major non-conformance is pending
- Quality Management System documentation, typically an ISO 13485 certificate
- Declarations covering any previously held or rejected CDSCO licenses, where applicable
Step-by-Step Process to File Form MD-4
- Register your company on the CDSCO SUGAM portal and complete the applicant profile
- Finalize and sign the manufacturing agreement with your chosen host facility
- Collect the host facility's Form MD-5 license copy, Site Master File, and QMS/ISO 13485 documents
- Prepare the Device Master File with full technical and labelling details of the product
- Fill Form MD-4 online with company, device, and host-facility details, and attach all supporting documents
- Pay the prescribed government fee and submit the application
- Respond promptly to any queries or clarification requests raised by the State Licensing Authority
- Cooperate with the site audit of the host facility conducted by the SLA or an authorized notified body
- Close out any non-conformance observations raised during the audit
- Once compliance is confirmed, the SLA grants the loan license in Form MD-6
Fees for Form MD-4 Application
| Fee Head | Indicative Amount |
| Loan license application — single manufacturing site | ₹5,000 |
| Each additional distinct Class A/B device under the same site | As per Second Schedule; verify current rate on SUGAM |
| Retention/maintenance fee (payable once every 5 years) | As per Second Schedule; verify current rate on SUGAM |
These figures reflect the Second Schedule of the Medical Devices Rules, 2017. Government fee notifications are updated periodically, so confirm the exact current amount on the CDSCO/SUGAM portal before submitting payment.
Timeline: How Long Does Form MD-4 Processing Take?
For a complete application with no missing documents, State Licensing Authorities commonly issue the Form MD-6 loan license within about 45 days of submission. Timelines can extend if the SLA raises queries, if the host facility audit surfaces non-conformances that need closure, or if state-level processing volumes are high. If your application is rejected, the SLA is required to communicate this in writing within 45 days, and you can appeal the rejection within 45 days of receiving that notice.
Validity & Renewal After Form MD-4 Is Approved
Once Form MD-4 is approved and the loan license is granted in Form MD-6, the license does not expire on a fixed date and does not need annual renewal. It remains valid indefinitely, provided the licensee pays a retention (maintenance) fee before the completion of five years from the date of grant. Missing this payment, or being found non-compliant, can lead the State Licensing Authority to suspend or cancel the license.
Common Reasons Form MD-4 Applications Get Rejected
- Device wrongly classified — filed as Class A/B when it actually falls under Class C or D
- Device Master File or Site Master File is incomplete or inconsistent with the application
- Host facility's Form MD-5 license does not cover the specific device being applied for
- Missing or invalid consent/agreement from the host manufacturer
- Gaps in ISO 13485 or Quality Management System compliance at the host site
- Delayed or incomplete responses to State Licensing Authority queries
- Data-entry or documentation mismatches on the SUGAM portal filing
Form MD-4 vs Other CDSCO Loan License Forms
| Form | Purpose | Applies To |
| Form MD-4 | Application for loan license (manufacture for sale/distribution) | Class A & Class B devices |
| Form MD-6 | Grant of loan license after MD-4 is approved | Class A & Class B devices |
| Form MD-8 | Application for loan license (manufacture for sale/distribution) | Class C & Class D devices |
| Form MD-10 | Grant of loan license after MD-8 is approved | Class C & Class D devices |
Why Choose Silvereye Certifications
Silvereye Certifications helps manufacturers, brand owners, and importers prepare and file Form MD-4 applications correctly the first time — from verifying the host facility's Form MD-5 coverage and compiling the Device Master File and Site Master File, to liaising with the State Licensing Authority through the audit and non-conformance closure stages. Our team stays current with CDSCO and Ministry of Health & Family Welfare updates so your filing reflects the latest documentation and fee requirements.
Frequently Asked Questions
What is Form MD-4 used for?
Form MD-4 is used to apply for a loan license to manufacture Class A or Class B medical devices for sale or distribution at a facility you don't own, under the Medical Devices Rules, 2017.
Who issues the license after Form MD-4 is approved?
The State Licensing Authority issues the loan license in Form MD-6 once your Form MD-4 application and the host-facility audit are cleared.
Can I file Form MD-4 for Class C or D devices?
No. Form MD-4 applies only to Class A and Class B devices. Class C and D devices use Form MD-8, which is reviewed by the Central Licensing Authority.
Do I need my own manufacturing facility to file Form MD-4?
No. The whole purpose of Form MD-4 is to let you manufacture at a host facility that already holds a valid manufacturing license for the same device category.
What documents are mandatory for Form MD-4?
Core documents include the Device Master File, Site Master File of the host facility, the host's Form MD-5 license copy, the signed manufacturing agreement, ISO 13485/QMS documentation, and company constitution proof.
How long does it take to get the license after filing Form MD-4?
A complete, error-free application commonly gets a decision within about 45 days, though timelines can extend if the State Licensing Authority raises queries or the facility audit finds non-conformances.
What is the fee for filing Form MD-4?
The indicative government fee is ₹5,000 for a single manufacturing site, with an additional fee for each distinct device — always confirm the current rate on the SUGAM portal before payment.
Does the Form MD-4 loan license need to be renewed every year?
No. Once granted in Form MD-6, the license stays valid indefinitely, subject to a retention fee payable once every five years.
What happens if my Form MD-4 application is rejected?
The State Licensing Authority must give written reasons within 45 days, and you can file an appeal within 45 days of receiving the rejection notice.
Can the host facility named in Form MD-4 work with more than one loan licensee?
Yes, provided the host's own manufacturing license (Form MD-5) covers the relevant device category and it can show adequate quality-system capacity during audits for each arrangement.
Is Form MD-4 filed online or offline?
Form MD-4 is filed online through the CDSCO SUGAM portal, along with all supporting documents and the prescribed fee payment.
