Medical Device Loan License in India: MD-6 and MD-10 for Class A to D Devices

What Is a Medical Device Loan License?

A medical device loan license is a licence under the Medical Devices Rules, 2017 that lets a company manufacture its own medical devices at another licensee's manufacturing site, where the host already makes the same device under its own licence. The rules define it in Rule 3 as a licence for a person who "intends to utilise the manufacturing site of other licensee".

The form depends on the device class. For Class A and Class B devices, you file an MD 4 form loan license application with the State Licensing Authority and receive an MD 6 loan license. For Class C and Class D devices, you file Form MD-8 with CDSCO and receive an MD-10 loan licence. Non-sterile, non-measuring Class A devices are outside this route, because they need only an online registration number.

A loan license for medical devices gives you the legal status of a manufacturer: your name is on the licence, you are responsible for the device, and your labels name you as the licence holder alongside the manufacturing site. It is the most common route for medical device loan licence manufacturing India-wide among brands that do not own a plant.

In India, Class A and B loan licences are decided by the State Drug Licensing Authority and Class C and D loan licences by CDSCO, with applications filed on ONDLS or your state drug licensing portal. Like manufacturing licences, loan licences are valid in perpetuity as long as the retention fee is paid every five years.

Who Needs a Loan License for Medical Devices?

• Device brands without a factory that want devices made under their own licence
• D2C and online health brands selling home-use devices such as monitors, supports or mobility aids under their own name
• Distributors and importers moving into Indian manufacturing of their own brand
• Pharma and FMCG companies adding a medical device range
• Start-ups that have finished development under a test licence and want to manufacture at a partner's plant
• Manufacturers needing extra capacity, or a device type their own plant cannot make

Is there a medical device brand owner license in India?

There is no separate medical device brand owner license India issues. A brand owner who wants a licence in its own name gets it through a loan licence (MD-6 or MD-10). A brand owner who only markets devices made under another company's licence does not hold a manufacturing licence, but its labels must correctly show the manufacturer, and it shares responsibility for the device on the market.

Medical Device Loan License by Class

The device's risk class decides the form, the authority, the audit and the timeline:

Loan license class A class B medical devices: MD-4 and MD-6

For a loan license class A class B medical devices route, the brand owner files the MD 4 form loan license application with the State Licensing Authority, with the Second Schedule fee, the Part II Fourth Schedule documents and an undertaking that the Fifth Schedule quality management system is met. For Class A, the state decides within 45 days without a prior audit, and a notified body must audit the site within 120 days after grant. For Class B, the notified body audits within 90 days of the application and reports within 30 days, and the state decides within 20 days of the report. The licence is granted on Form MD-6.

Loan license class C class D medical devices: MD-8 and MD-10

The MD 8 MD 10 loan license class C D route goes to CDSCO as the Central Licensing Authority. CDSCO scrutinises the application within 45 days, inspects within 60 days through at least two medical device officers or a notified body, and decides within 45 days of the inspection report. A useful saving for loan license class C class D medical devices applicants: under the proviso to Rule 23(1), no inspection is needed for a loan licence if the host site is already licensed to manufacture that device.

Medical device loan license in Uttar Pradesh

A medical device loan license Uttar Pradesh brands need for Class A or B devices is granted by the Food Safety and Drug Administration (FSDA), Uttar Pradesh, when the host site is in the state, such as in Noida, Greater Noida, Ghaziabad, Kanpur or Lucknow. Class C and D loan licences for Uttar Pradesh sites are still granted by CDSCO, whose North Zone office is in Ghaziabad.

Loan Licence vs Own Manufacturing vs Contract Manufacturing

The choice between loan licence vs own manufacturing medical device routes, and contract manufacturing medical devices India-style, comes down to control, cost and time:

Third party medical device manufacturing in India

Third party medical device manufacturing India brands use is legal both ways: the manufacturer can add your device to its own licence, or you can hold your own loan licence for production at its site. Choose a loan licence when you want the device on your own licence, plan to use more than one manufacturer, or sell to hospitals and tenders that ask for the brand owner's licence. Choose contract manufacturing on the manufacturer's licence when you want the fastest, simplest start.

See our medical device manufacturing license page if you plan to build your own plant.

Eligibility for a Medical Device Loan License

To get an MD-6 or MD-10, these must be in place:

1. A host site licensed for the same device. The definition of a loan licence requires the host to manufacture the same device under its own licence (MD-5 or MD-9).
2. A loan licence agreement allowing you to use the host's site, equipment and staff for your device.
3. A quality management system meeting the Fifth Schedule of the Medical Devices Rules, which closely follows ISO 13485, covering your device at the host site, with an undertaking that it is met.
4. Competent technical staff under Rule 22: a degree in engineering, pharmacy or science with at least two years' relevant experience, or a diploma with at least four years' experience.
5. A Device Master File for your device and the host's Plant Master File.
6. Correct classification of every device, because the class decides the form and the authority.

Choosing the Right Host Manufacturer

Your loan licence is only as strong as your host. Before signing:

• Check the host's licence: MD-5 or MD-9 current, retention fee paid, and your exact device type and class covered
• Check the last audit or inspection: notified body or CDSCO findings and how they were closed
• Check capability: equipment, clean rooms, sterilisation (in-house or contracted) and testing for your device
• Check the quality system: design transfer, document control, complaint handling, CAPA and supplier control
• Visit the site and meet the people who will make your device

What the loan licence agreement should cover

• Devices, models and quantities, and the right to use the host's site, equipment and staff
• Who supplies components and materials, and who approves suppliers
• Batch testing and release before supply, as Rule 26 requires
• Records: device history records, batch records and sales records, and your access to them
• Retention of one sample of each batch of invasive devices and IVDs for 180 days after expiry
• Complaint handling, adverse event reporting within the time the rules set, and recalls
• Notice of any change at the host site, and an exit plan if the host's licence is suspended

Medical Device Loan License Documents

The medical device loan license documents are set out in Part II of the Fourth Schedule to the Medical Devices Rules. A complete MD-4 or MD-8 file usually contains:

Applicant and agreement

• Constitution of the firm and details of proprietors, partners or directors
• Loan licence agreement with the host
• Copy of the host's MD-5 or MD-9 licence, with the retention fee receipt
• Details and qualifications of the competent technical staff, with consent letters
• Fee payment receipt

Device and site

• Device Master File: description, intended use, classification, design and materials, specifications, risk management, verification and validation, labels and instructions for use
• Plant Master File of the host site
• Undertaking that the Fifth Schedule quality management system is met
• ISO 13485 certificate of the site, where available
• Test reports, sterilisation and packaging validation, and biocompatibility data, as applicable

Regovex prepares the file so that your Device Master File, the host's Plant Master File, the agreement and the labels all describe the same device at the same site.

Medical Device Loan License Process

The medical device loan license process is online for every class. In India, Class A and B applications go to the State Drug Licensing Authority and Class C and D applications to CDSCO, both through ONDLS or your state drug licensing portal.

How to get loan license for medical device

1. Classify each device and confirm it is not a non-sterile, non-measuring Class A device.
2. Choose and check the host site, licensed for the same device.
3. Sign the loan licence agreement.
4. Prepare the Device Master File, obtain the host's Plant Master File and confirm the Fifth Schedule QMS covers your device.
5. File the application: MD-4 for Class A or B, MD-8 for Class C or D, with the fee and documents.
6. Audit or inspection: notified body audit (Class A after grant, Class B before grant) or CDSCO inspection (Class C and D, unless the site is already licensed for the device).
7. Close any non-conformities quickly.
8. Receive the loan licence on MD-6 or MD-10, and start production.

The MD 4 application SUGAM filing

The MD 4 application SUGAM filing happens on CDSCO's online system for medical devices, widely called MD SUGAM, which handles both state and central device applications. The applicant registers once, files Form MD-4 or MD-8, uploads the documents and pays online. For Class A and B, the notified body that will audit the site is engaged and coordinated alongside the application.

Medical Device Loan License Fees

The medical device loan license fees are set in the Second Schedule and match the fees for a manufacturing licence of the same class:

Source: CDSCO medical device fee list. Where a site makes devices of more than one class, the higher-class fee applies to the site. Our professional fee is quoted in writing, with government and notified body fees shown separately.

Worked example

A brand loan-licensing three Class B devices at one host site pays ₹5,000 for the site and ₹500 for each device, ₹6,500 in total, plus the notified body's audit charges. The same three devices in Class C would cost ₹50,000 plus ₹3,000, or ₹53,000.

Timelines for a Medical Device Loan License

If an application is rejected, you may appeal within 45 days: to the State Government for MD-6, or to the Central Government for MD-10. The appeal is to be decided within 60 days.

Medical Device Loan License Validity and Retention

On medical device loan license validity, Rule 29 is clear: an MD-6 or MD-10 is valid in perpetuity, as long as the retention fee is paid before the end of each five-year period from the date of issue. If paid late, a late fee of 2% of the retention fee applies for each month or part of a month, for up to 180 days; after that, the licence is deemed cancelled. Regovex records the retention date on the day your licence is granted.

Change in constitution

Under Rule 27, if the constitution of your firm changes, such as a new partner or a conversion to a company, you must inform the licensing authority within 45 days and apply for a fresh licence within 180 days. The existing licence stays valid until a decision is made.

After the Loan Licence: Conditions Under Rule 26

As the loan licensee, you are the legal manufacturer of the device, even though it is made at the host's site. Rule 26 applies to MD-6 and MD-10 holders just as it does to MD-5 and MD-9 holders:

• Produce the licence whenever an officer asks for it
• Report suspected unexpected serious adverse events to the licensing authority within 15 days of learning of them
• Get prior approval for major changes, and notify minor changes within 30 days
• Test each batch before release for sale or distribution
• Withdraw non-conforming lots when directed
• Keep an audit book in Form MD-11
• Retain one sample of each batch of invasive devices and IVDs for 180 days after expiry
• Keep manufacturing and sales records for every batch
• Supply package inserts or user manuals with the device
• Operate under competent technical staff
• Notify the authority if manufacturing stops or the site closes for 30 days or more

Labelling loan-licensed devices

Labels must show the device name, the manufacturer's name and address with the licence number, the manufacturing site address, batch or lot number, manufacturing and expiry dates where applicable, and the other particulars the Medical Devices Rules require. For loan-licensed devices, make sure the label identifies you as the licensee and the host site as the place of manufacture, exactly as on your MD-6 or MD-10.

Audits after grant

For Class A, the notified body audit happens within 120 days after grant, and further audits follow on the notified body's schedule. For all classes, the licensing authority and CDSCO can inspect the host site. Treat the host's quality system as your own: agree in writing how audit findings at the site will be shared and fixed.

Selling the devices

The loan licence lets you manufacture and sell your devices. If you store or distribute them from a separate warehouse, that premises needs an MD-42 registration or a wholesale licence. See our MD-42 registration page.

Common Mistakes in Medical Device Loan License Applications

• Choosing a host not licensed for the same device. A loan licence is only possible where the host already makes the same device.
• Wrong class, wrong authority. Filing a Class C device with the state, or a Class B device with CDSCO, starts the process again.
• A quality system on paper only. The Class A post-grant audit and the Class B pre-grant audit check that the QMS actually works.
• Technical staff who do not meet Rule 22. Check degrees, diplomas and years of experience before naming the person.
• Labels that do not match the licence on manufacturer, site or licence number.
• Missing the retention date, after which the licence is deemed cancelled.
• No exit plan if the host's licence is suspended.

Who Does What Under a Medical Device Loan Licence

A loan licence works only when the brand owner and the host agree in writing who is responsible for each part of the quality system. This split is what the notified body or CDSCO will look for:

Regovex drafts this split as a quality agreement alongside the loan licence agreement, so audits find a clear answer to every question. Review it once a year, or whenever the host changes a process, supplier or key person.

From Test Licence to Loan Licence

Many device start-ups follow a simple path: develop the device and make prototypes under an MD-13 test licence, then move to a loan licence at a licensed host for commercial production, and later build their own plant. The test data, verification and validation reports from the MD-13 stage go straight into the Device Master File for the MD-4 or MD-8 application. See our medical device test license page.

Special Cases: Sterile Devices, IVDs and Higher-Risk Devices

Sterile devices

If your device is sterile, the host's licence and quality system must cover sterilisation, either in-house or through a validated contract steriliser. Your Device Master File needs the sterilisation validation, packaging validation and shelf-life data for your device, not just for the host's own products.

IVD kits and reagents

IVD loan licences follow the same MD-4 / MD-8 routes by class. The host must be licensed for the same type of IVD, and your file needs performance evaluation data for your kit. Cold-chain storage and lot release testing should be written into the quality agreement.

Class C and D devices

Higher-risk devices such as implants and life-supporting equipment need deeper technical files and CDSCO review. The saving under Rule 23(1), where no inspection is needed because the host is already licensed for the device, can shorten the timeline significantly, so confirm the host's licence covers your exact device.

Selling to Hospitals and Tenders

Hospitals and government tenders usually ask for the manufacturing licence in the bidder's own name, the device's class, and test reports. A loan licence meets that requirement for brand owners. Keep the MD-6 or MD-10, the retention fee receipt, the host's licence and recent test reports ready as one tender pack. Some tenders also ask for the host's ISO 13485 certificate and the last audit report, so agree with the host in advance that these can be shared with buyers.

A Typical Medical Device Loan Licence Timeline

Checklist Before You Apply for a Medical Device Loan Licence

• Every device classified, with the reasoning recorded
• Host site licensed (MD-5 or MD-9) for the same device, retention fee paid
• Host's last audit or inspection reviewed
• Loan licence agreement and quality agreement signed
• Technical staff meet Rule 22, with consent letters
• Device Master File complete, with labels and instructions for use
• Host's Plant Master File and QMS undertaking ready
• Test, validation and biocompatibility reports available as applicable
• Fee calculated per site and per distinct device
• Retention date to be diarised on grant

How to Choose a Medical Device Loan License Consultant

A medical device loan license consultant should protect you from the long-term risks of depending on a host. Ask:

1. Will you check the host's licence, audit history and capability before I sign?
2. Who confirms the class of each device, and on what basis?
3. Who writes the Device Master File and checks it against the host's Plant Master File?
4. Will you prepare us for the notified body audit or CDSCO inspection?
5. Will you track retention, changes and adverse event obligations after approval?
6. Are government, notified body and professional fees shown separately?

Why Brands in India Choose Regovex for Their Medical Device Loan License

• Host checks first: licence scope, retention status, audit history, capability and quality system of the host site
• Correct classification of every device, so the file goes to the right authority the first time
• Device Master Files written to match the host's Plant Master File, the agreement and the labels
• Audit and inspection preparation, with a mock audit and help closing any non-conformities
• Query replies within 24–48 hours at the state and CDSCO
• After-care: retention fee, major and minor change notifications, adverse event reporting and MD-42 for your warehouse
• Transparent pricing, with government, notified body and professional fees shown separately in writing
• 99.8% approval rate across 100+ clients, rated 4.9/5 in verified client feedback

As a CDSCO registration consultant and drug regulatory consultant in India with state FDA approval experience, Regovex handles your loan licence at both the state and CDSCO level, and your own manufacturing licence if you build a plant later.

Medical Device Loan License Services in India and Nearby Areas

Regovex helps device brands, D2C health companies, distributors, pharma and FMCG companies and start-ups in India. Class A and B applications are decided by the State Drug Licensing Authority and Class C and D applications by CDSCO, all filed on ONDLS or your state drug licensing portal. Documents are collected digitally, and we coordinate with your host manufacturer directly.

We also serve businesses in .

Related services:

• Medical Device Manufacturing License in India
• MD-42 Registration in India
• Medical Device Test License
• Medical Device Import License (MD-15)
• CDSCO Registration in India

What Our Clients Say

"I had great experience working with Regovex Consulting on the regulatory side of my product. Since the product category was relatively new and the guidelines were not very clearly defined, it required additional research and careful interpretation of the regulations." — Parichit Dhawan, Director, Feorah Wellness & Cosmetics

"I got my Drug Wholesale License through Regovex Consulting, and Devansh and his team provided complete end-to-end support, from premises selection to timely approval." — Bilal Ahmed Khan, Founder, Medwell Pharma

Medical device clients include Access 2 Healthcare and Project Life.