CDSCO Medical Device Loan License: Complete Guide to MD-4, MD-6, MD-8 & MD-10

• Class A & B: Form MD-4 application → State Licensing Authority → license granted in Form MD-6
• Class C & D: Form MD-8 application → Central Licensing Authority → license granted in Form MD-10
• You don't need your own factory — you manufacture at a partner's already-licensed facility under contract
• Validity is indefinite, subject to a retention/maintenance fee paid once every five years

Introduction

A CDSCO Medical Device Loan License lets a company manufacture, sell, or distribute a medical device using another manufacturer's licensed facility, without building its own factory. For Class A and Class B devices, you apply in Form MD-4 to the State Licensing Authority, which grants the license in Form MD-6. For Class C and Class D devices, you apply in Form MD-8 to the Central Licensing Authority, which grants the license in Form MD-10.

The license stays valid indefinitely if a retention fee is paid every five years, and it is issued under the Medical Devices Rules, 2017.

What Is a CDSCO Medical Device Loan License?

A CDSCO Medical Device Loan License is a regulatory permission issued under the Medical Devices Rules, 2017, that lets a company manufacture a medical device for sale or distribution at a facility it does not own. Instead of investing in a factory, testing lab, and full-time technical staff, the applicant (the loan licensee) enters into an agreement with an existing manufacturer (the host site) that already holds a valid manufacturing license for the same category of device.

The Central Drugs Standard Control Organization, working through the State Licensing Authority or the Central Licensing Authority depending on device risk class, reviews this arrangement and grants the loan license once it is satisfied that the host facility, quality systems, and documentation meet the required standards.

Who Needs a CDSCO Medical Device Loan License?

This license is relevant if you fall into any of these categories:

• A brand owner who wants to sell a medical device under its own name but does not operate a manufacturing unit
• A company that has design and marketing capability but not the capital or space for GMP-compliant manufacturing
• An existing manufacturer looking to add a new device category by using a partner's licensed line instead of building a new one
• A startup validating market demand before committing to its own factory

CDSCO Loan License for Class A & B Devices — Form MD-4 and Form MD-6

Class A and Class B medical devices are treated as low-to-moderate risk under Schedule I of the Medical Devices Rules, 2017 — common examples include thermometers, surgical gloves, stethoscopes, catheters, and disposable syringes. Because of this lower risk profile, licensing authority for these devices sits with the State Licensing Authority (SLA) rather than the central CDSCO office.

Eligibility for MD-4 (Class A & B)

• The applicant must be registered as a legal entity in India and hold a valid SUGAM portal account
• The host manufacturing facility must already hold a valid manufacturing license (Form MD-5) for the same device category
• A signed agreement or contract must exist between the applicant and the host facility covering the manufacturing arrangement
• The device must fall under Class A or Class B as per the CDSCO device classification list

Documents Required for MD-4/MD-6

• Company incorporation proof, GST registration, and identity/address proof of the applicant
• Device Master File — generic name, trade name, intended use, model number, shelf life, and storage conditions
• Site Master File of the host manufacturing facility
• Copy of the host facility's valid manufacturing license (Form MD-5)
• Signed agreement between the applicant and the host manufacturer
• Quality Management System documentation (ISO 13485 certificate, where applicable)
• Affidavits and declarations as prescribed under the application form

Step-by-Step Process for MD-4 to MD-6

• Register the company on the CDSCO SUGAM portal and create the applicant profile
• Prepare Form MD-4 with complete device details and the host-facility agreement
• Upload the Site Master File, Device Master File, host license copy, and supporting declarations
• Pay the prescribed loan license fee for the application
• The State Licensing Authority scrutinises the application and may ask for additional documents
• A notified body or SLA official may audit the host manufacturing site for quality-system compliance
• Any non-conformance raised during the audit must be closed with a corrective action report
• Once compliance is confirmed, the SLA grants the loan license in Form MD-6

CDSCO Loan License for Class C & D Devices — Form MD-8 and Form MD-10

Class C and Class D devices are classified as higher-risk, notified medical devices under the Medical Devices Rules, 2017. Because of the greater risk to patient safety, licensing authority for this category rests with the Central Licensing Authority (CLA) rather than the state government, and the process involves a more detailed facility inspection.

Eligibility for MD-8 (Class C & D)

• The applicant must be a registered Indian entity with a SUGAM portal login
• The host manufacturing site must hold a valid manufacturing license (Form MD-9) for the same device class
• The host facility must comply with the Quality Management System requirements under the Fifth Schedule of the Medical Devices Rules
• A binding manufacturing agreement between the applicant and the host site must be in place before filing

Documents Required for MD-8/MD-10

• Application Form MD-8 with full technical details of the device and its intended use
• Manufacturing agreement/contract between the applicant and the host facility
• Copy of the host facility's valid manufacturing license (Form MD-9)
• Site Master File and Device Master File, including design drawings and risk-analysis reports
• Quality Management System certification (ISO 13485) of the host facility
• Test reports covering device design and performance
• Technical staff qualification details and company registration/GST proof

Step-by-Step Process for MD-8 to MD-10

• Complete SUGAM portal registration for the applicant company
• Draft and submit Form MD-8 with the manufacturing agreement and technical documentation
• Pay the prescribed government fee for the Class C/D loan license application
• The Central Licensing Authority reviews the submission for completeness and compliance
• CDSCO inspects the manufacturing site — this inspection is expected within 60 days of the application date
• Any observations from the inspection must be addressed through a compliance/NC closure report
• On satisfactory compliance, the Central Licensing Authority grants the loan license in Form MD-10

The overall Class C/D loan license process typically takes about 4 to 5 months from submission to grant, given the additional inspection and central-level scrutiny involved.

MD-4/MD-6 vs MD-8/MD-10: Key Differences

CDSCO Loan License Registration Fees

Fee figures above are indicative and drawn from the Second Schedule of the Medical Devices Rules, 2017. Because government fee notifications are revised from time to time, always confirm the current applicable fee on the CDSCO/SUGAM portal or with a regulatory consultant before filing.

Timeline For CDSCO Loan License Registration: How Long Does It Take?

• Class A/B (MD-4 to MD-6): Processing time varies by state licensing authority workload and typically moves faster once the host-facility audit is cleared
• Class C/D (MD-8 to MD-10): Commonly takes around 4 to 5 months, factoring in document scrutiny, the 60-day inspection window, and any non-conformance closure
• If the application is rejected, the authority must communicate this in writing within 45 days, and the applicant can appeal within 45 days of receiving that rejection

Validity, Retention Fee & Renewal

A CDSCO Medical Device Loan License — whether granted in Form MD-6 or Form MD-10 — remains valid indefinitely and does not require repeated renewal in the traditional sense. Instead, the licensee must pay a license retention (maintenance) fee before the completion of five years from the date the license was issued. As long as this fee is paid on time and the license is not suspended or cancelled by the SLA or CLA for non-compliance, the license continues in perpetuity.

Common Reasons for Rejection & How to Avoid Them

• Host facility's manufacturing license (MD-5 or MD-9) does not cover the same device category being applied for
• Incomplete or inconsistent Device Master File and Site Master File documentation
• Manufacturing agreement between applicant and host site is missing key clauses on quality responsibility
• Quality Management System gaps identified during the facility audit that are not closed in time
• Declarations or affidavits not matching the details filled in Form MD-4 or MD-8

Conclusion

Silvereye Certifications works with manufacturers, brand owners, and importers across India to prepare and file CDSCO Medical Device Loan License applications end to end — from checking host-facility eligibility and compiling the Device Master File and Site Master File, to coordinating the SLA/CLA inspection and closing any non-conformance observations. Our team tracks CDSCO and Ministry of Health & Family Welfare regulatory updates closely so your MD-4/MD-6 or MD-8/MD-10 filing reflects the current documentation and fee requirements at the time of submission.

Frequently Asked Questions