Home
›
Medical Device Loan License Registration
Introduction
A medical device loan license lets a manufacturer produce Class A, B, C, or D medical devices at another company's already-licensed premises, without owning a factory. For Class A and B devices, the application is filed in Form MD-4 with the State Licensing Authority and granted as Form MD-6.
For Class C and D devices, the application is filed in Form MD-8 with the Central Licensing Authority (CDSCO) and granted as Form MD-10. Both license types remain valid indefinitely once granted, subject to a retention fee paid every five years, and typically take 45 days (Class A/B) to 4-5 months (Class C/D) to process.
What Is a Medical Device Loan License?
A medical device loan license is a manufacturing authorisation granted under the Medical Devices Rules, 2017 to a company that wants to manufacture medical devices for sale or distribution without owning its own manufacturing premises. Instead, the applicant enters into a formal arrangement to use the premises of another manufacturer who already holds a valid license for that device class, and applies to the appropriate licensing authority for approval to manufacture under their own name at that facility.
This route is widely used by medical device startups, diagnostics companies, and brands that want to launch products in India without the capital investment of building a GMP-compliant plant. Which form you file, and which authority grants your license, depends entirely on the risk classification of your device.
Understanding Medical Device Risk Classes (A, B, C, D)
The Medical Devices Rules, 2017 classify devices into four risk categories, and your loan license route depends entirely on which class your product falls into:
| Class |
Risk Level |
Examples |
Licensing Authority |
| Class A |
Low risk |
Thermometers, tongue depressors, non-invasive dressings |
State Licensing Authority (SLA) |
| Class B |
Low-moderate risk |
Hypodermic needles, suction equipment, some IVDs |
State Licensing Authority (SLA) |
| Class C |
Moderate-high risk |
Lung ventilators, bone fixation plates, orthopaedic implants |
Central Licensing Authority (CLA/CDSCO) |
| Class D |
High risk |
Heart valves, implantable devices, high-risk IVDs |
Central Licensing Authority (CLA/CDSCO) |
Class A and B devices are regulated by the State Licensing Authority (SLA) of the state where the manufacturing premises are located. Class C and D devices — being higher risk — fall under the Central Licensing Authority (CLA), which operates through CDSCO.
Loan License Forms at a Glance: MD-4/MD-6 vs MD-8/MD-10
Here is the complete form-to-form comparison for both loan license routes, side by side:
| Parameter |
Class A & B Loan License |
Class C & D Loan License |
| Application Form |
MD-4 |
MD-8 |
| Grant of License Form |
MD-6 |
MD-10 |
| Licensing Authority |
State Licensing Authority (SLA) |
Central Licensing Authority (CLA / CDSCO) |
| Governing Documents |
Fourth Schedule (Part II), Fifth Schedule (QMS) |
Fourth Schedule (Part II & III), Fifth Schedule (QMS) |
| Typical Government Fee |
Rs. 5,000 per manufacturing site + Rs. 500 per distinct device |
Rs. 50,000 per manufacturing site + Rs. 1,000 per distinct device |
| Site Inspection / Audit |
Notified body audit of manufacturing site |
Notified body audit of manufacturing site, appointed by CLA |
| Typical Processing Time |
Around 45 days from complete application |
Around 4-5 months, including a site inspection window |
| Validity |
Perpetual, subject to 5-yearly retention fee |
Perpetual, subject to 5-yearly retention fee |
| Rejection Notice Period |
Written notice within 45 days if rejected |
Written notice within 45 days if rejected |
Who Needs a Medical Device Loan License?
Medical device startups and small manufacturers who don't yet own a GMP/QMS-compliant facility.
Established brands adding a new device class or product line through a contract manufacturer instead of expanding their own plant.
Foreign companies partnering with an Indian manufacturing unit to produce devices locally under their own brand.
In-vitro diagnostic (IVD) companies that want to manufacture through an already-licensed facility rather than building test/production infrastructure from scratch.
The manufacturing site you intend to use must already hold — or be capable of demonstrating — compliance with the Quality Management System requirements under the Fifth Schedule of the Medical Devices Rules, 2017, and must be prepared for a notified-body audit as part of the application.
Documents Required for MD-4 (Class A & B Loan License)
The MD-4 application must be filed online with the requisite documents and fee as specified in the Second Schedule. Commonly required documents include:
Covering letter and constitution details of the applicant/manufacturer.
Establishment/site ownership or tenancy agreement for the borrowed manufacturing premises.
Duly notarised copies of any existing quality certificates for the manufacturing site.
ISO 13485 certificate for the manufacturing site, if available.
Plant master file / site master file as specified in Appendix I of the Fourth Schedule, covering layout, key personnel, and equipment.
Device master file describing the device design, intended use, and manufacturing process.
Undertaking that the manufacturing site complies with the Quality Management System requirements under the Fifth Schedule.
Test license and quality control test data, where applicable for domestic manufacturers.
Fee payment challan/receipt as specified in the Second Schedule.
Documents Required for MD-8 (Class C & D Loan License)
The MD-8 application is more extensive, since Class C and D devices carry higher risk. In addition to the documents required for MD-4, applicants typically also submit:
Site or plant master file covering plant layout, organisation chart, key technical personnel qualifications, equipment list, and any contract activities.
Full Quality Management System documentation as per the Fifth Schedule — quality manual, quality policy, document and record control, management responsibility, internal audit system, and corrective/preventive action procedures.
Declarations from the nominated Manufacturing Chemist and Analytical Chemist, along with their qualification, experience, and appointment documents.
Registration from the District Industries Centre and consent to establish/operate from the State Pollution Control Board.
Performance evaluation report, for in-vitro diagnostic (IVD) devices.
Test license for generation of quality control data, where applicable.
Fee payment challan/receipt as specified in the Second Schedule.
Step-by-Step Process: MD-4 Application to MD-6 Grant (Class A & B)
Confirm your device's classification as Class A or Class B under the Medical Devices Rules, 2017.
Finalise the manufacturing arrangement with a facility that already holds a valid license or is prepared to demonstrate QMS compliance.
Register on the SUGAM portal and prepare the device master file, site master file, and Fifth Schedule QMS undertaking.
Complete Form MD-4 online, upload all supporting documents, and pay the prescribed fee under the Second Schedule.
Submit the application to the concerned State Licensing Authority for scrutiny.
A notified body audits the manufacturing site and submits its report to the State Licensing Authority.
Respond to any deficiency memo the SLA raises during scrutiny of the application or audit report.
On satisfactory verification, the State Licensing Authority grants the loan license in Form MD-6, typically within 45 days of a complete application.
If rejected, the SLA must notify you in writing within 45 days, and you may reapply after that period.
Step-by-Step Process: MD-8 Application to MD-10 Grant (Class C & D)
Confirm your device's classification as Class C or Class D under the Medical Devices Rules, 2017.
Finalise the manufacturing arrangement and confirm the facility can meet Fifth Schedule QMS requirements for higher-risk devices.
Register on the SUGAM portal and draft the MD-8 application with full site/plant master file and QMS documentation.
Upload all required documents — including chemist declarations, pollution control consents, and performance evaluation reports for IVDs — along with the prescribed fee.
Submit the application to the Central Licensing Authority (CDSCO) through the online medical device portal.
The CLA appoints a notified body to audit the actual manufacturing site, generally within 60 days of application submission.
The notified body submits its audit report to the CLA for scrutiny alongside the application documents.
Respond to any deficiency memo raised during document or audit scrutiny.
On satisfactory verification, the Central Licensing Authority grants the loan license in Form MD-10 — the overall process typically takes 4 to 5 months.
If rejected, the CLA must notify you in writing within 45 days, and you may reapply after that period.
Medical Device Loan License Registration Fees
Fees for both loan license routes are prescribed under the Second Schedule of the Medical Devices Rules, 2017 and are commonly cited as follows:
| Fee Component |
Class A & B (MD-4/MD-6) |
Class C & D (MD-8/MD-10) |
| Loan license fee (per manufacturing site) |
Rs. 5,000 |
Rs. 50,000 |
| Fee per distinct medical device |
Rs. 500 |
Rs. 1,000 |
| Retention fee (before completion of 5 years) |
As per Second Schedule |
As per Second Schedule |
These are the fees most consistently cited across regulatory consulting sources referencing the Second Schedule. Because government fee notifications are revised periodically, always confirm the current fee structure on the SUGAM portal or with the relevant licensing authority before submitting payment.
Validity, Retention Fee, and Renewal
Neither MD-6 nor MD-10 loan licenses carry a fixed expiry date. Both remain valid in perpetuity once granted, provided the license holder pays the prescribed retention fee before completion of every five-year period from the date of issue.
There is no traditional "renewal" application — instead, a retention fee keeps the license active every 5 years.
If the retention fee is not paid on time, the license can be suspended or cancelled by the SLA (for MD-6) or the CLA (for MD-10).
If manufacturing is stopped for more than 30 days, the license holder must notify the concerned licensing authority.
If a license is cancelled, the applicant can generally appeal to the CLA or SLA within 45 days of the cancellation.
Medical Device Loan License Timeline at a Glance
| Stage |
Class A & B (MD-4/MD-6) |
Class C & D (MD-8/MD-10) |
| Document & QMS preparation |
Varies by applicant readiness |
Varies by applicant readiness |
| Notified body site audit |
As scheduled after application |
Within ~60 days of submission |
| Authority scrutiny & decision |
Within ~45 days of complete application |
Overall process ~4-5 months |
| Grant of license |
Form MD-6 |
Form MD-10 |
| Retention fee due |
Before completion of every 5 years |
Before completion of every 5 years |
Why Choose Silvereye Certifications For Getting Your Medical Device Loan License
Choosing the correct loan license route — MD-4/MD-6 for Class A and B, or MD-8/MD-10 for Class C and D — starts with getting your device classification right. From there, the strength of your site master file, device master file, and Fifth Schedule QMS documentation determines whether your application sails through in one attempt or gets stuck in repeated deficiency memos.
Silvereye Certifications supports medical device manufacturers end-to-end with loan license registration — from confirming device classification and structuring the manufacturing arrangement, to preparing MD-4/MD-8 documentation, coordinating the notified body audit, and tracking the five-year retention cycle so your MD-6 or MD-10 license never lapses.
Next step Planning to manufacture medical devices through a third-party facility? Talk to Silvereye Certifications for a classification review and end-to-end MD-4/MD-6 or MD-8/MD-10 filing support before you submit your application.
Frequently Asked Questions: Medical Device Loan License Registration
A medical device loan license is a manufacturing authorisation that lets a company produce medical devices at another already-licensed manufacturer's facility, instead of owning its own plant. It's granted under the Medical Devices Rules, 2017.
MD-4 is the application form for a loan license to manufacture Class A or Class B medical devices, filed with the State Licensing Authority. MD-8 is the application form for a loan license to manufacture Class C or Class D medical devices, filed with the Central Licensing Authority.
MD-6 is the loan license granted for Class A and Class B devices by the State Licensing Authority. MD-10 is the loan license granted for Class C and Class D devices by the Central Licensing Authority. Both are the 'grant' certificates issued after MD-4 or MD-8 approval respectively.
Any manufacturer that wants to produce medical devices for sale or distribution but doesn't own a compliant manufacturing facility can apply, provided they have a formal arrangement to use premises that meet Fifth Schedule QMS requirements.
No. That's the core purpose of the loan license route — you manufacture at another company's already-compliant, licensed facility under a formal arrangement, instead of setting up your own unit.
Class A/B loan licenses (MD-6) are typically decided within 45 days of a complete MD-4 application. Class C/D loan licenses (MD-10) generally take around 4 to 5 months, including a notified-body site audit.
Fee schedules commonly cite around Rs. 5,000 per manufacturing site plus Rs. 500 per distinct device for Class A/B (MD-4), and around Rs. 50,000 per site plus Rs. 1,000 per distinct device for Class C/D (MD-8), under the Second Schedule. Always confirm the current fee on the SUGAM portal before payment.
No fixed expiry applies. Both MD-6 and MD-10 loan licenses remain valid in perpetuity, provided the retention fee is paid before completion of every five-year period from the date of issue.
The license can be suspended or cancelled by the concerned licensing authority. If cancelled, the applicant can typically appeal within 45 days, though it's best to track the five-year deadline proactively rather than relying on a cancellation notice.
Yes. Foreign companies frequently partner with an Indian manufacturing facility that already holds the relevant class license, and apply for a loan license to produce devices locally under their own brand.
