Medical Device Loan Licence in India: MD-6 vs MD-10, Eligibility, Application Process and MDR 2017 Compliance

Manufacturing medical devices in India is regulated under the Medical Devices Rules, 2017 (MDR 2017), framed under the Drugs and Cosmetics Act, 1940. For businesses that intend to manufacture medical devices for sale or distribution but do not have an independently licensed manufacturing facility, the loan licence route can provide an important regulatory pathway.

A medical device loan licence allows an applicant to utilise the manufacturing site of another licensed manufacturer for manufacturing the same medical device already manufactured by that licensee at that site, subject to the applicable requirements of MDR 2017. The applicable licence depends primarily on the risk classification of the device.

For devices subject to the licensing regime:

• Class A and Class B: application in Form MD-4 and loan licence in Form MD-6, under the State Licensing Authority (SLA).
• Class C and Class D: application in Form MD-8 and loan licence in Form MD-10, under the Central Licensing Authority (CLA).

CDSCO's current regulatory information confirms the four risk classes as Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk).

Important: Certain Class A non-sterile and non-measuring medical devices are exempt from the licensing regime, subject to the conditions prescribed under MDR 2017. Therefore, device classification and exemption status should be confirmed before selecting the loan-licence route.

What Is a Medical Device Loan Licence?

Under MDR 2017, a loan licence is a licence issued by the applicable Licensing Authority to a person intending to utilise the manufacturing site of another licensee for manufacturing the same medical device as manufactured by that licensee at that site.

The loan licence route is therefore different from simply outsourcing manufacturing to an unrelated third-party facility. The proposed manufacturing site must satisfy the applicable regulatory requirements, and the existing manufacturer whose premises are being utilised must already hold the relevant manufacturing licence for the same device.

The applicant does not necessarily have to own a separate manufacturing facility. Instead, manufacturing can be undertaken at the premises of an existing licensed manufacturer, subject to the conditions of the loan licence and MDR 2017.

A loan licence is not an exemption from regulatory compliance. The loan-licensee remains subject to applicable requirements relating to the quality management system, manufacturing controls, technical personnel, testing, records, product standards, labelling and other regulatory obligations.

Which Forms Are Used for a Medical Device Loan Licence?

The applicable loan licence depends on the risk classification of the medical device.

Form MD-6 – Loan Licence for Class A and Class B Medical Devices

Form MD-6 is the loan licence for manufacturing eligible Class A and Class B medical devices for sale or distribution.

The application is made in Form MD-4 to the State Licensing Authority (SLA). Form MD-4 itself is prescribed for an application for a loan licence to manufacture Class A or Class B medical devices.

However, the Class A category requires an important qualification.

Class A non-sterile and non-measuring devices

Under the 2022 amendment to MDR 2017, manufacturing of Class A non-sterile and non-measuring medical devices is exempt from specified licensing provisions, subject to mandatory registration and the applicable conditions under the Rules. The relevant amendment also specifically modified Form MD-4 and Form MD-6 to exclude such devices from the licensing requirement.

Accordingly, an applicant should not automatically assume that every Class A device requires an MD-4/MD-6 loan licence.

CDSCO also states that Class A non-sterile and non-measuring devices do not require a manufacturing licence, but require registration and compliance with applicable labelling and standards requirements.

Form MD-10 – Loan Licence for Class C and Class D Medical Devices

Form MD-10 is the loan licence for manufacturing Class C and Class D medical devices for sale or distribution.

The application is made in Form MD-8 to the Central Licensing Authority (CLA). CDSCO's current regulatory information specifically identifies Form MD-8 as the application route for a Class C/D loan licence and Form MD-10 as the resulting loan licence.

Class C devices are categorised as moderate-high risk, while Class D devices are categorised as high risk. These higher-risk devices are therefore subject to the central licensing framework and applicable regulatory assessment requirements.

MD-6 vs MD-10: Key Difference

The correct risk classification of the proposed device is therefore the starting point for determining the applicable loan-licence pathway.

Who Can Apply for a Medical Device Loan Licence?

A business considering the loan-licence route should generally ensure that:

1. The proposed medical device is correctly classified under MDR 2017.
2. The device is not covered by an applicable exemption.
3. An appropriate existing licensed manufacturing site has been identified.
4. The existing manufacturing site is licensed for the same medical device, as required by the loan-licence framework.
5. The site has the infrastructure, equipment, personnel and quality systems required for the proposed manufacturing activity.
6. The applicant can meet the applicable technical, quality and documentation requirements under MDR 2017.

The applicant and the existing manufacturer whose premises are utilised are distinct regulatory parties. The loan licence is granted to the applicant, while manufacturing is carried out at the specified premises in accordance with the applicable regulatory requirements.

Medical Device Loan Licence Application Process

The application process generally involves the following stages.

1. Determine the Medical Device Classification

The first step is to determine whether the device is Class A, B, C or D in accordance with the risk-based classification framework under the First Schedule to MDR 2017 and the applicable CDSCO classification list.

Classification depends on factors such as:

• intended purpose;
• duration of use;
• invasiveness;
• whether the device is active or non-active;
• whether the device has a measuring function;
• whether the device is sterile; and
• other risk parameters prescribed under the Rules.

CDSCO maintains and updates risk-based classification information, so applicants should verify the latest applicable CDSCO classification list rather than relying solely on an older classification document.

2. Check Whether Any Exemption Applies

Before preparing a loan-licence application, determine whether the device falls within an exemption.

In particular, Class A non-sterile and non-measuring medical devices are subject to a specific exemption from the licensing regime, with registration and other applicable requirements continuing to apply.

This can materially change the regulatory pathway.

3. Identify an Appropriate Licensed Manufacturing Site

The applicant should identify an existing licensed manufacturing facility capable of manufacturing the proposed medical device.

The facility should have appropriate:

• manufacturing infrastructure;
• machinery and equipment;
• testing facilities or testing arrangements;
• qualified technical personnel;
• quality management systems;
• environmental controls, where applicable;
• storage facilities; and
• documentation and record-keeping systems.

Most importantly, the loan-licence concept under MDR 2017 is linked to utilisation of another licensee's site for manufacturing the same medical device already manufactured there.

4. Prepare the Regulatory Documentation

The application must be supported by the documents prescribed under MDR 2017, including the applicable requirements of the Fourth Schedule and device-specific information.

Depending on the device and application, the documentation may include information relating to:

• applicant and manufacturing-site details;
• medical device particulars;
• manufacturing process;
• quality management system;
• technical personnel;
• machinery and equipment;
• testing arrangements;
• product specifications;
• applicable standards;
• labelling;
• package insert or user manual, where applicable; and
• other technical and regulatory information.

The exact document set should be determined based on the device, classification and applicable CDSCO requirements.

5. Submit the Application

For eligible Class A and Class B devices, the loan-licence application is made in Form MD-4 to the State Licensing Authority.

For Class C and Class D devices, the loan-licence application is made in Form MD-8 to the Central Licensing Authority.

CDSCO identifies the online SUGAM system as the online application route for Class C/D manufacturing and loan licences.

The prescribed fee and applicable supporting documents must be submitted with the application.

6. Regulatory Scrutiny, Audit and Inspection

For Class A and Class B devices, the applicable Quality Management System requirements under MDR 2017 must be met. The framework also provides for registered Notified Bodies to undertake audits of Class A and Class B manufacturing sites in accordance with the Rules and as applicable to the licensing process.

For Class C and Class D devices, the Central Licensing Authority undertakes the applicable regulatory scrutiny and may require inspection of the manufacturing site in accordance with MDR 2017.

7. Inspection Exception for Certain Class C/D Loan Licences

A significant provision applies to Class C and Class D loan licences.

Under Rule 23 of MDR 2017, inspection of the manufacturing site is not required for grant of a loan licence where the manufacturing site is already licensed to manufacture the same medical device for sale or distribution.

This means that an applicant should carefully examine the existing licence of the proposed manufacturing partner before assuming that a fresh site inspection will be required.

8. Grant of the Loan Licence

After considering the application, supporting documents, applicable assessment or inspection requirements and compliance with MDR 2017, the relevant Licensing Authority may grant the loan licence.

The licence is:

• Form MD-6 for eligible Class A/Class B devices; or
• Form MD-10 for Class C/Class D devices.

Quality Management System Requirements

A loan licence does not remove the requirement to comply with applicable quality management requirements.

Manufacturing must be carried out in accordance with the applicable Quality Management System requirements under the Fifth Schedule of MDR 2017, together with applicable device standards and regulatory requirements.

Depending on the device and regulatory pathway, the applicant and manufacturing site should have appropriate systems covering:

• production controls;
• process validation, where applicable;
• testing;
• calibration;
• equipment maintenance;
• environmental controls;
• supplier controls;
• batch and production records;
• complaint handling;
• adverse-event reporting;
• recall procedures; and
• change control.

The specific requirements should always be assessed against the device and its classification rather than applying a generic checklist to every medical device.

Post-Licence Compliance Obligations

Obtaining MD-6 or MD-10 is not the end of the regulatory process. The loan-licensee must continue to comply with the applicable conditions of the licence and MDR 2017.

Key obligations include, as applicable:

Adverse Event Reporting

The licence holder must inform the applicable Licensing Authority of the occurrence of a suspected unexpected serious adverse event and the action taken, including recall, within the prescribed period. Rule 26 specifies a 15-day period from the event coming to the notice of the licence holder.

Major Changes

Applicable major changes to the manufacturing process, premises, equipment, quality system or other regulated matters may require prior approval from the relevant Licensing Authority.

Minor Changes

Applicable minor changes are required to be reported within the timeframe prescribed under MDR 2017.

Testing and Batch Release

Where applicable, required testing must be performed before release of batches, and appropriate records must be maintained.

Records

The licence holder must maintain prescribed manufacturing and sales records and make them available for inspection when required.

Recall

Where a medical device presents a regulatory or safety concern, the licence holder may be required to withdraw or recall affected products in accordance with MDR 2017 and directions of the Licensing Authority.

Audit and Inspection Records

The applicable audit and inspection records should be maintained as prescribed, including the relevant requirements relating to Form MD-11.

Labelling and User Information

Medical devices must comply with the applicable labelling requirements under MDR 2017. Package inserts, instructions for use and user manuals must be provided wherever required.

Validity of Medical Device Loan Licence

A common misconception is that an MD-6 or MD-10 licence expires after a fixed number of years.

Under Rule 29 of MDR 2017, licences and loan licences issued in Forms MD-5, MD-6, MD-9 and MD-10 remain valid in perpetuity, subject to payment of the applicable licence retention fee within the prescribed period and continued compliance with the Rules and licence conditions.

The retention fee is linked to a five-year cycle. CDSCO's current regulatory material confirms that the licensing authority may permit payment after the due date but before expiry of 180 days, subject to the applicable late fee calculated at 2% per month.

Failure to comply with the retention-fee requirements can therefore have serious consequences for the continued validity of the licence.

Class C and Class D Devices Under the Licensing Regime

Businesses planning to manufacture higher-risk devices should also note that CDSCO implemented the licensing regime for all Class C and Class D medical devices with effect from 1 October 2023, pursuant to GSR 102(E) dated 11 February 2020.

Accordingly, manufacturers of Class C and D devices intended for sale or distribution must follow the applicable licensing pathway under MDR 2017, including the loan-licence pathway where the statutory requirements are satisfied.

Practical Checklist Before Applying for a Loan Licence

Before submitting an application, an applicant should verify:

• Correct risk classification of the medical device.
• Whether the device is subject to any exemption.
• Whether the proposed manufacturing site is already appropriately licensed.
• Whether the site manufactures the same medical device.
• Availability of required manufacturing equipment and infrastructure.
• Availability of qualified technical personnel.
• Compliance with applicable QMS requirements.
• Availability of testing facilities or approved testing arrangements.
• Device-specific technical documentation.
• Labelling and packaging compliance.
• Applicable fees.
• Correct application form — MD-4 or MD-8.
• Correct Licensing Authority — SLA or CLA.
• Post-licence procedures for complaints, adverse events, recalls and changes.
• System for maintaining manufacturing, testing and sales records.
• Licence retention-fee compliance mechanism.

Frequently Asked Questions About Medical Device Loan Licences

What is a loan licence for medical devices in India?

A medical device loan licence is a licence that permits a person to utilise the manufacturing site of another licensed manufacturer to manufacture the same medical device already manufactured by that licensee at the site, subject to MDR 2017.

What is Form MD-6?

Form MD-6 is the loan licence for eligible Class A and Class B medical devices manufactured for sale or distribution. The corresponding application is made in Form MD-4 to the State Licensing Authority.

What is Form MD-10?

Form MD-10 is the loan licence for Class C and Class D medical devices manufactured for sale or distribution. The corresponding application is made in Form MD-8 to the Central Licensing Authority.

Is a loan licence the same as outsourcing manufacturing?

Not necessarily. A loan licence is a specific regulatory mechanism under MDR 2017 and is linked to the utilisation of another licensee's manufacturing site for manufacturing the same medical device. Ordinary commercial outsourcing arrangements should not automatically be treated as equivalent to a statutory loan licence.

Does a loan-licensee need to own a manufacturing facility?

No. The purpose of the loan-licence mechanism is to permit utilisation of another licensed manufacturer's manufacturing site, subject to the applicable requirements of MDR 2017.

Is inspection required for an MD-10 loan licence?

Not necessarily. Rule 23 contains a specific exception under which inspection of the manufacturing site is not required for a Class C/D loan licence where the site is already licensed to manufacture the same medical device for sale or distribution.

How long is an MD-6 or MD-10 licence valid?

MD-6 and MD-10 are valid in perpetuity, subject to payment of the applicable licence retention fee and continued compliance with MDR 2017.

Are all Class A medical devices required to obtain an MD-6 loan licence?

No. Class A non-sterile and non-measuring medical devices are subject to a specific exemption from the licensing regime, subject to registration and other applicable requirements.

Conclusion

A medical device loan licence in India can provide an efficient regulatory pathway for businesses that want to manufacture medical devices without establishing and independently licensing their own manufacturing premises.

However, a loan licence is not simply permission to use another company's factory. The MDR 2017 framework requires careful consideration of the device classification, applicability of exemptions, existing manufacturing licence, same-device requirement, quality management system, technical personnel, manufacturing controls, testing, documentation and continuing regulatory obligations.

For eligible Class A and Class B medical devices, the loan-licence pathway generally involves Form MD-4 → MD-6 under the State Licensing Authority, subject to the specific Class A exemption.

For Class C and Class D medical devices, the pathway is Form MD-8 → MD-10 under the Central Licensing Authority. CDSCO's current framework confirms the central licensing requirement for these higher-risk devices.

Businesses planning to use a medical device loan licence should therefore begin with correct device classification and regulatory pathway assessment, followed by verification of the proposed manufacturing site's licence and capability. Proper preparation at this stage can reduce regulatory deficiencies and help ensure continued compliance after the licence is granted.

Last Updated : 02 Sep 2026