Manufacturing medical devices in India requires compliance with the Medical Devices Rules, 2017 (MDR 2017) and the requirements of the applicable licensing authority. For Class C and Class D medical devices, the Central Licensing Authority is responsible for the manufacturing and loan-licensing pathway.
Four forms are particularly important:
The practical distinction is straightforward: MD-7 leads to MD-9 for manufacturing at the applicant's own licensed site, while MD-8 leads to MD-10 where the applicant uses the manufacturing site of another licensee under a loan-licence arrangement.
This guide explains the purpose of each form, the applicable licensing pathway, documentation, inspection requirements, timelines and important compliance considerations under MDR 2017.
Regulatory note: Applicants should always verify the latest CDSCO notifications, amendments, application checklists and portal requirements before submitting an application.
Under MDR 2017, medical devices are classified according to risk as:
For manufacturing Class C and Class D medical devices, the licensing pathway is handled by the Central Licensing Authority. The application is submitted through the applicable online system in the prescribed form.
Class A and Class B devices follow the applicable State Licensing Authority pathway, subject to the provisions and exemptions that apply to the particular device.
Correct classification is therefore an important first step before selecting the applicable application form.
CDSCO also maintains the applicable risk-classification information and updates its medical-device regulatory materials from time to time. Manufacturers should check the current classification applicable to their specific device before filing an application.
Form MD-7 is the application for a licence to manufacture Class C or Class D medical devices for sale or distribution.
It is used when the applicant intends to manufacture the devices at its manufacturing premises and seeks the corresponding manufacturing licence from the Central Licensing Authority.
Under MDR 2017, the application must be accompanied by the prescribed fee and applicable documents and information required under the Rules and relevant CDSCO checklist.
Depending on the device and applicable requirements, the application package may include:
The current CDSCO checklist for Form MD-7 specifically identifies items such as the Plant Master File, Quality Management System requirements and Device Master File as part of the application documentation.
The exact documentation should be determined from the current CDSCO checklist applicable to the device, rather than relying on a generic document list.
Form MD-9 is the manufacturing licence granted for Class C or Class D medical devices for sale or distribution.
In the standard own-site manufacturing pathway:
MD-7 → scrutiny/assessment → inspection where applicable → MD-9
Once the Central Licensing Authority is satisfied that the applicable requirements have been met, the manufacturing licence is granted in Form MD-9.
The licence authorises the licensee to manufacture the specified medical devices at the approved manufacturing premises for sale or distribution, subject to the conditions of the licence and continuing compliance with MDR 2017.
The current CDSCO checklist identifies Form MD-9 as the licence associated with a fresh Form MD-7 application for Class C and Class D medical devices.
Form MD-8 is the application for a loan licence to manufacture Class C or Class D medical devices for sale or distribution.
A loan licence is relevant where the applicant proposes to use the manufacturing site of another licensee rather than manufacture the device at its own manufacturing premises.
The MDR 2017 framework defines a loan licence in relation to using the manufacturing site of another licensee for manufacturing the same medical device that the licensee is authorised to manufacture at that site.
Therefore, a loan-licence application is not simply an outsourcing arrangement. The applicant must satisfy the specific regulatory requirements applicable to a loan licence.
Depending on the application and applicable CDSCO requirements, documentation may include:
The applicable CDSCO checklist should always be reviewed before filing because documentation requirements can vary depending on the device and regulatory circumstances.
Form MD-10 is the loan licence granted for manufacturing Class C or Class D medical devices for sale or distribution.
The standard loan-licence pathway can therefore be summarised as:
MD-8 → scrutiny/assessment → MD-10
The MD-10 authorises the loan-licence holder to manufacture the specified medical devices at the manufacturing site identified under the applicable licence arrangement, subject to the conditions of the licence and MDR 2017.
CDSCO's current materials identify MD-8 as the application for a loan manufacturing licence and MD-10 as the resulting loan licence for Class C and Class D devices.
|
Form |
Purpose |
Type |
Manufacturing arrangement |
|
MD-7 |
Application for manufacturing licence |
Application |
Applicant's manufacturing site |
|
MD-9 |
Manufacturing licence |
Licence |
Applicant's licensed manufacturing site |
|
MD-8 |
Application for loan licence |
Application |
Another eligible licensed manufacturer's site |
|
MD-10 |
Loan manufacturing licence |
Licence |
Manufacturing at the specified parent/licensee site |
The easiest way to remember the forms is:
Own-site manufacturing:
MD-7 → MD-9
Loan-licence manufacturing:
MD-8 → MD-10
The main difference is the manufacturing-site arrangement.
With the MD-7/MD-9 route, the applicant seeks a manufacturing licence for its own manufacturing premises.
With the MD-8/MD-10 route, the applicant seeks a loan licence to use the manufacturing site of another licensee under the conditions prescribed by MDR 2017.
The two routes should not be treated as interchangeable. The applicant must determine which arrangement accurately reflects its manufacturing model and then submit the appropriate application.
For Class C and Class D manufacturing applications, inspection requirements depend on the applicable licensing pathway and circumstances.
For an ordinary manufacturing-licence application, the Central Licensing Authority may arrange inspection of the manufacturing premises as prescribed under MDR 2017.
For a loan-licence application, the Rules provide that inspection of the manufacturing site is not required where the site is already licensed to manufacture the same medical device for sale or distribution, subject to the applicable regulatory requirements.
Therefore, it is more accurate to describe the loan-licence inspection position as a specific regulatory provision, rather than suggesting that loan licences are generally subject to reduced scrutiny.
Applicants should also be prepared for regulatory queries or additional requirements where the authority considers them necessary.
Manufacturers of medical devices must establish and maintain a Quality Management System in accordance with the requirements applicable under the Fifth Schedule of MDR 2017.
For an MD-7 application, the CDSCO checklist includes documentation relating to the Quality Management System, including an undertaking that the manufacturing site complies with the Fifth Schedule.
ISO 13485 certification may form part of a manufacturer's quality-management framework and may be requested or relevant under particular CDSCO checklists. However, manufacturers should not assume that holding an ISO 13485 certificate by itself satisfies every regulatory requirement.
The regulatory requirement should be assessed against the current MDR 2017 provisions and the applicable CDSCO checklist for the device and application.
The Plant Master File (PMF) and Device Master File (DMF) are important components of a Class C or Class D manufacturing application.
The Plant Master File provides information about the manufacturing facility, including areas such as:
The Device Master File provides information relating to the particular medical device, such as:
The current CDSCO MD-7 checklist specifically includes the Plant Master File and Device Master File within the application documentation.
Manufacturers should prepare these files according to the applicable appendices of the Fourth Schedule and the current CDSCO requirements.
A simplified MD-7 process is:
Confirm whether the device is Class C or Class D under the applicable CDSCO classification.
Decide whether the device will be manufactured at the applicant's own manufacturing premises or under a qualifying loan-licence arrangement.
Prepare the applicable Plant Master File, Device Master File, QMS documentation, technical information, site documents, fee and other required documents.
Submit the application through the applicable online regulatory portal along with the prescribed fee and supporting documents.
The Central Licensing Authority reviews the application and supporting information.
Where inspection is required, the manufacturing premises are inspected in accordance with MDR 2017.
After completion of the applicable assessment and inspection process, the authority may grant the manufacturing licence in Form MD-9 or take the applicable regulatory action.
The loan-licence pathway generally follows these steps:
Identify the licensed manufacturing site that will be used and confirm that the applicable regulatory conditions are satisfied.
Prepare the applicable agreement and supporting documentation between the applicant and the manufacturing licensee.
Compile the required application, site information, technical documents, QMS documentation, parent-manufacturer information and other applicable records.
Submit the application and prescribed fee through the applicable online system.
The Central Licensing Authority reviews the application and supporting documentation.
Where the applicable requirements are satisfied, the loan licence is granted in Form MD-10.
MDR 2017 specifies regulatory timelines for scrutiny, inspection and decision-making.
For Class C and Class D applications, the Rules provide for:
These are regulatory timelines and should not be presented as a guaranteed overall approval time.
Actual application processing can be affected by:
Applicants should therefore avoid relying on the statutory timeline as a guaranteed commercial launch date.
The validity of the manufacturing and loan licences should be understood separately from the initial application process.
Under MDR 2017, licences such as MD-9 and MD-10 remain valid in perpetuity, subject to the applicable conditions, including payment of the prescribed licence retention fee at the specified intervals, unless the licence is suspended or cancelled in accordance with the Rules.
Therefore, it is more accurate to discuss licence retention rather than describing the process simply as periodic licence renewal.
Manufacturers should monitor the applicable retention-fee requirements and CDSCO notices to maintain the licence in force.
Manufacturers may subsequently seek permission to manufacture additional medical devices at the licensed manufacturing site.
The applicable process depends on the nature of the additional device or proposed change and the relevant provisions of MDR 2017 and current CDSCO procedures.
Applicants should therefore avoid assuming that every product addition or manufacturing change follows the same generic endorsement procedure.
Before introducing an additional device or making a significant change, the licence holder should review the current CDSCO requirements and determine whether prior approval, permission, amendment or another regulatory action is required.
Certain devices may require additional regulatory permissions before a manufacturing licence can be granted.
For example, MDR 2017 contains specific provisions concerning investigational medical devices and new medical devices. Where such provisions apply, the applicant may need to obtain the applicable prior permission before proceeding with the manufacturing-licence application.
Form MD-27 should therefore not be described as automatically applicable to every medical device without a predicate. The appropriate regulatory pathway depends on the device's classification and regulatory status.
Manufacturers should assess the specific device against the current MDR 2017 provisions and applicable CDSCO guidance before filing.
A well-prepared application can reduce avoidable queries. Common areas that may require careful attention include:
The exact requirements vary according to the device and regulatory pathway. Applicants should use the latest CDSCO checklist applicable to their application.
No. MD-7 is the application form for a manufacturing licence for Class C or Class D medical devices. The corresponding licence is issued in MD-9.
No. MD-8 is the application for a loan licence. The corresponding loan licence is issued in MD-10.
MD-7 is used for an application for a manufacturing licence, whereas MD-8 is used for an application for a loan licence.
The key practical difference is the manufacturing-site arrangement.
MD-9 is the manufacturing licence for the applicant's manufacturing arrangement, while MD-10 is the loan licence granted under the applicable loan-licence pathway.
Yes. The CDSCO framework identifies MD-7 as the application and MD-9 as the manufacturing licence for Class C and Class D medical devices.
Yes. MD-8 is the application and MD-10 is the corresponding loan licence for Class C and Class D medical devices.
Not necessarily. MDR 2017 contains a specific provision under which inspection of the manufacturing site is not required where the site is already licensed to manufacture the same medical device for sale or distribution, subject to the applicable conditions.
Applicants should not treat ISO 13485 certification alone as a universal substitute for the QMS requirements under MDR 2017. The applicable CDSCO checklist and regulatory requirements should be checked for the particular device and application.
MDR 2017 provides specified periods for scrutiny and, where applicable, inspection and decision-making. However, the overall practical timeline can vary depending on the completeness of the application, regulatory queries, inspection findings and other factors.
The MD-9/MD-10 licensing framework provides for continuing validity subject to the applicable retention-fee and compliance requirements. Manufacturers should therefore monitor licence-retention obligations rather than assume an annual renewal process.
The choice depends primarily on the manufacturing arrangement.
Before choosing either route, confirm the device classification, manufacturing arrangement, site requirements and current CDSCO checklist.
The four forms can be remembered as follows:
MD-7 = Application for manufacturing licence
MD-9 = Manufacturing licence
MD-8 = Application for loan licence
MD-10 = Loan licence
For Class C and Class D medical devices, the correct form depends on the proposed manufacturing arrangement and applicable regulatory requirements.
A successful application requires more than completing the correct form. Manufacturers should ensure that their classification, manufacturing site, Quality Management System, Plant Master File, Device Master File, technical documentation, labelling and other supporting documents are consistent with MDR 2017 and the current CDSCO requirements.
Because CDSCO requirements and guidance can be amended or updated, applicants should verify the latest official documents before submitting an application.
Last Updated : 22 Sep 2026
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