CDSCO Registration

Form MD-10 (Loan License)

Form MD-10 is the loan licence to manufacture Class C and Class D medical devices at another licensee’s premises. The application is made in Form MD-8. CDSCO’s regulatory pathway lists MD-8 to MD-10 among the Central Licensing Authority’s Class C and D licences, while one legal source says the State Licensing Authority issues it after inspection. It remains valid permanently if the retention fee is paid every five years, and one source lists the retention fee as Rs 50,000 per manufacturing site plus Rs 1,000 per distinct device.

We prepare MD-8, the host MD-9 and agreement, DMF and documents and prepare for inspection.

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Service Overview

What is Form MD-10 (Loan License)?

A Class C and D loan licence lets an entity without a factory manufacture higher-risk medical devices at the licensed premises of another manufacturer holding an MD-9 licence. It is governed by Rules 21 to 25 and 29 of the Medical Devices Rules, 2017.

Documents include MD-8 with fee, a copy of the host’s valid MD-9 and the agreement with the host, constitution documents and ID proofs of the applicant, Device Master File, labelling, IFU, technical and clinical documents and details of quality arrangements. The licence is issued after verification and a physical site inspection. The issuing authority differs between sources, so confirm on the portal.

Form MD-10 (Loan License)

Who Needs This Service

Brand owners and startups marketing higher-risk devices such as implants, IVD kits and equipment made at contract manufacturers need MD-10.

Companies without capital for a factory use this route.

Hosts must hold MD-9.

If your devices are Class A or B, use MD-6.

Key Benefits

Brand launch without owning a plant
Host and documents verified
Inspection prepared
Portal filing
Perpetual validity

Next Steps & Related Services

After MD-10, manage quality with the host. Related services: MD-9, MD-6, MD-42 and MDR registration.

Common Mistakes

Wrong authority assumption.
Weak host agreement.
Missing DMF.
Unpaid retention fee.
Skipping inspection prep.

Timeline, Costs & Practical Tips

Timelines depend on inspection.

Practical tip: confirm the authority on the portal.

Additional Information

MDR 2017 allows loan licensing for higher-risk devices with oversight.

Practical Scenarios

Scenario 1:

A brand outsources implants.

Scenario 2:

A startup outsources IVD kits.

Scenario 3:

A company changes host.

Process & Planning

For an MD-10 loan licence, select a host with a valid MD-9 licence and agree responsibilities for quality, change control and complaint handling. Prepare the Device Master File, labelling, instructions for use and technical or clinical documents, then file Form MD-8 on the CDSCO portal with fees. Expect verification and a site inspection. Because the issuing authority is described differently in sources, confirm it on the portal. Planning checklist: check the retention fee (one source says Rs 50,000 per site plus Rs 1,000 per device), keep the host agreement current and plan for audits.

Written By

Raghav Sharma

Operations Executive

10+ Years Experience

As seen on

Raghav Sharma has 10+ years of experience covering Company Registration - Operation, MCA Services - Operation, Corporate Operation, Import Export Services - Operation, Goverment Licence Services - Operation, FSSAI - Operation, SEBI - Operation, Labour Compliance - Operation, Fund Raising - Operation, Licence & Certificate - Operations.

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Frequently asked questions

Need clarity?

Which classes does MD-10 cover?

Class C and D.

Who issues it?

CDSCO pathway shows the CLA; one source says the SLA.

Is a host licence needed?

Yes, MD-9.

What is the retention fee?

One source says Rs 50,000 per site plus Rs 1,000 per device.

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