Which CDSCO Form Is Required for a Medical Device Manufacturing Licence in India?

Manufacturing medical devices in India requires compliance with the applicable provisions of the Medical Devices Rules, 2017, framed under the Drugs and Cosmetics Act, 1940, as amended.

Before commencing manufacturing activities for sale or distribution, manufacturers must determine the applicable regulatory pathway, medical device risk classification, licensing authority, and prescribed application form. The requirements differ depending on whether the device falls under Class A, B, C, or D and whether the manufacturer intends to operate at its own facility or use another manufacturer's premises under a loan licence arrangement.

The Central Drugs Standard Control Organisation (CDSCO) performs central regulatory functions, while the State Licensing Authority handles specified manufacturing licence applications under the Rules.

This guide explains the principal CDSCO forms used for medical device manufacturing, the relevant regulatory distinctions, and the documentation manufacturers should prepare before applying.

1. Which CDSCO Form Is Required for a Medical Device Manufacturing Licence?

Under Rules 20 and 21 of the Medical Devices Rules, 2017, the prescribed forms depend on the device's classification and the manufacturing arrangement.

Forms MD-3 and MD-4 are submitted to the State Licensing Authority for the relevant Class A and Class B pathways. Forms MD-7 and MD-8 are submitted to the Central Licensing Authority for Class C and Class D devices. The corresponding licence forms are MD-5, MD-6, MD-9, and MD-10, respectively.

Important: The Class A licensing pathway excludes non-sterile and non-measuring Class A devices covered by the applicable exemption. Such devices must be assessed under the separate registration requirements introduced by G.S.R. 777(E), dated 14 October 2022.

These forms should be interpreted alongside the current Rules, applicable amendments, and relevant notifications.

2. Understanding the Medical Device Risk Classification

The Medical Devices Rules, 2017, classify medical devices according to risk, taking into account factors such as intended use, duration of contact, invasiveness, and other characteristics specified in the classification rules.

The four risk classes are:

• Class A: Low-risk medical devices.
• Class B: Low-to-moderate-risk medical devices.
• Class C: Moderate-to-high-risk medical devices.
• Class D: High-risk medical devices.

The classification determines the applicable manufacturing regulatory pathway and helps identify the competent licensing authority.

Manufacturers should not select a form based solely on the product's commercial name. They should establish the intended purpose and apply the relevant classification rules under the First Schedule of the Medical Devices Rules, 2017.

3. Form MD-3 and Form MD-5: Regular Manufacturing Licence for Eligible Class A and Class B Devices

What is Form MD-3?

Form MD-3 is the prescribed application form for a licence to manufacture eligible Class A and Class B medical devices for sale or distribution.

Under Rule 20, the application is submitted to the State Licensing Authority through the prescribed online portal, accompanied by the applicable fee and documentation specified under the Rules.

What is Form MD-5?

Form MD-5 is the corresponding manufacturing licence granted for eligible Class A and Class B medical devices when the licensing authority is satisfied that the applicable requirements have been met.

Key compliance requirements

Applicants should assess the following:

• Correct medical device classification.
• Manufacturing site and applicant details.
• Product-specific information and technical documentation.
• Applicable Quality Management System requirements under the Fifth Schedule.
• Documentation prescribed under the Fourth Schedule.
• Applicable audit and inspection requirements.

The audit requirements and process can differ according to the device class and applicable provisions. Manufacturers should therefore verify the requirements for their particular device before filing.

4. Form MD-4 and Form MD-6: Loan Licence for Eligible Class A and Class B Devices

A loan licence pathway may apply when a manufacturer proposes to manufacture medical devices using the premises of another manufacturer under the arrangement permitted by the Rules.

What is Form MD-4?

Form MD-4 is the application form for a loan licence to manufacture eligible Class A and Class B medical devices for sale or distribution.

What is Form MD-6?

Form MD-6 is the corresponding loan licence granted under the applicable provisions.

Applicants should ensure that the proposed manufacturing arrangement, facility, technical responsibilities, and supporting documents comply with the applicable requirements.

A loan licence should not be treated as interchangeable with a regular manufacturing licence. The correct form depends on the actual manufacturing arrangement and the relevant regulatory provisions.

5. Form MD-7 and Form MD-9: Manufacturing Licence for Class C and Class D Devices

Class C and Class D medical devices follow the manufacturing licensing pathway under Rule 21, which is administered by the Central Licensing Authority.

What is Form MD-7?

Form MD-7 is the application form for a licence to manufacture Class C or Class D medical devices for sale or distribution.

The application must be submitted through the prescribed online portal with the applicable fee and documentation required under Rule 21 and the relevant provisions of the Fourth Schedule.

What is Form MD-9?

Form MD-9 is the corresponding manufacturing licence issued for Class C and Class D medical devices when the Central Licensing Authority is satisfied that the applicable requirements have been fulfilled.

Important compliance considerations

Depending on the device and applicable requirements, the manufacturer may need to provide:

• Device Master File and other relevant technical documentation.
• Manufacturing site and facility information.
• Quality management system documentation.
• Risk management and safety and performance evidence.
• Product testing, validation, or clinical evidence where applicable.
• Information about the manufacturing process and technical personnel.

The precise requirements depend on the product and applicable provisions. Applicants should consult the current official checklist rather than treating this illustrative list as exhaustive.

6. Form MD-8 and Form MD-10: Loan Licence for Class C and Class D Devices

For eligible Class C and Class D devices manufactured under a loan licence arrangement, the applicable forms are MD-8 and MD-10.

• Form MD-8: Application for a loan licence to manufacture Class C or Class D medical devices for sale or distribution.
• Form MD-10: Corresponding loan licence granted under the Rules.

Applications fall under the Central Licensing Authority pathway under Rule 21.

Applicants should confirm that the proposed arrangement, manufacturing facility, technical documentation, and quality management system satisfy the requirements applicable to the devices concerned.

7. Special Regulatory Pathway for Class A Non-Sterile and Non-Measuring Medical Devices

Not every Class A medical device follows the ordinary manufacturing licensing pathway.

Under G.S.R. 777(E), dated 14 October 2022, specified Class A non-sterile and non-measuring medical devices are exempted from the applicable licensing regime, subject to the conditions of the notification.

The notification introduced Chapter IIIB into the Medical Devices Rules, 2017, providing a registration pathway for these devices.

Manufacturers must assess whether their products meet the relevant Class A classification and the specific non-sterile and non-measuring conditions. Where the exemption applies, the manufacturer must follow the prescribed registration requirements rather than automatically applying through Form MD-3.

The exemption should not be interpreted as removing every regulatory obligation. Applicable registration, safety and performance, standards, and other relevant requirements must still be assessed.

8. Which Licensing Authority Should You Approach?

The applicable authority depends on the device class and the provisions governing the application.

The Central Licensing Authority is the Drugs Controller General of India (DCGI), as defined in the Rules.

Manufacturers should verify the applicable pathway, including any relevant exemption or subsequent amendment, before preparing their application.

9. Documents Required for a Medical Device Manufacturing Licence

The documents required depend on the medical device, risk class, manufacturing arrangement, and applicable provisions of the Rules.

The Fourth Schedule specifies documentation requirements, while the Fifth Schedule addresses the Quality Management System for medical devices and in vitro diagnostic medical devices.

Commonly relevant documents and information may include:

1. Applicant and business details: Legal constitution, registration details, and information identifying the applicant.
2. Manufacturing site details: Site address, ownership or tenancy documentation, and facility information.
3. Plant Master File: Where applicable under the prescribed requirements.
4. Device Master File: Technical documentation applicable to the device and regulatory pathway.
5. Product details: Generic name, intended purpose, model details, and other prescribed product information.
6. Quality Management System documentation: Evidence and undertakings required under the Fifth Schedule, as applicable.
7. Technical personnel details: Information concerning the competent technical staff responsible for manufacturing activities.
8. Safety and performance evidence: Applicable test reports, validation, risk management, and other required technical evidence.
9. Application and fee documents: Prescribed application form, fee payment, declarations, and supporting records.

The exact documents must be checked against the relevant parts of the Fourth Schedule, the Fifth Schedule, applicable amendments, and the licensing authority's current checklist.

10. Step-by-Step Process for Applying for a Manufacturing Licence

Step 1: Identify the device and intended purpose

Establish the product's intended medical purpose, specifications, manufacturing site, and proposed manufacturing activities.

Step 2: Determine the risk class

Classify the device under the First Schedule of the Medical Devices Rules, 2017. Consider any applicable special requirements for in vitro diagnostic devices.

Step 3: Select the correct form

Choose between MD-3, MD-4, MD-7, and MD-8 according to the device class and the regular or loan licence arrangement.

Step 4: Identify the competent authority

Determine whether the application falls under the State Licensing Authority or the Central Licensing Authority.

Step 5: Prepare the prescribed documentation

Compile the relevant technical, site, quality management, personnel, and application documents in accordance with the Fourth and Fifth Schedules and the current checklist.

Step 6: Submit the application

Submit through the prescribed online portal, pay the applicable fee, and respond to regulatory queries or audit and inspection requirements as applicable.

Step 7: Maintain compliance after licensing

Once the licence is granted, comply with its conditions and the applicable requirements for manufacturing, quality management, records, labelling, and post-market obligations.

11. Common Mistakes Manufacturers Should Avoid

Manufacturers should avoid the following errors:

• Choosing an application form before confirming the risk class.
• Confusing a regular manufacturing licence with a loan licence.
• Assuming that all Class A devices require the same licensing pathway.
• Overlooking the registration requirements for exempted Class A non-sterile and non-measuring devices.
• Applying to the wrong licensing authority.
• Providing inconsistent product or manufacturing site information.
• Omitting applicable technical or quality management documentation.
• Relying on an outdated checklist without reviewing applicable amendments and notifications.

A device-specific regulatory assessment can help identify the correct application pathway and reduce avoidable delays.

12. How MDR Consultants Can Help

MDR Consultants provides regulatory support to medical device manufacturers seeking to manufacture and market medical devices in India.

Our services may include:

• Medical device classification under the Medical Devices Rules, 2017.
• Identification of the applicable manufacturing licence or registration pathway.
• Guidance on Forms MD-3, MD-4, MD-7, and MD-8, as applicable.
• Support with technical documentation and application preparation.
• Guidance on regular and loan licence arrangements.
• Assistance with regulatory queries and applicable post-licensing requirements.

The scope of support depends on the device, manufacturing arrangement, and applicable regulatory requirements.

Conclusion

The correct CDSCO form for a medical device manufacturing licence in India depends on the device's risk class, the manufacturing arrangement, and the applicable provisions of the Medical Devices Rules, 2017.

Forms MD-3 and MD-5 relate to the regular manufacturing licence pathway for eligible Class A and Class B devices. Forms MD-4 and MD-6 relate to the corresponding loan licence pathway. Forms MD-7 and MD-9 cover regular manufacturing licences for Class C and Class D devices, while Forms MD-8 and MD-10 cover the corresponding loan licence pathway.

Class A non-sterile and non-measuring devices covered by G.S.R. 777(E) follow a separate registration pathway subject to the conditions of the notification.

Before applying, manufacturers should confirm the device classification, licensing authority, applicable exemptions, required documents, and current regulatory provisions.

Need assistance with a medical device manufacturing licence in India?

Contact MDR Consultants for regulatory support with medical device classification, manufacturing licence applications, documentation, and CDSCO compliance.

Frequently Asked Questions

1. Which form is required for a medical device manufacturing licence in India?

For eligible Class A and Class B devices, Form MD-3 is generally used for a regular manufacturing licence application. For Class C and Class D devices, Form MD-7 is generally used. The corresponding licence forms are MD-5 and MD-9.

2. What is the difference between Form MD-5 and Form MD-9?

Form MD-5 is the manufacturing licence form for eligible Class A and Class B devices. Form MD-9 is the manufacturing licence form for Class C and Class D devices.

3. Which forms apply to a medical device loan licence?

Forms MD-4 and MD-6 apply to the eligible Class A and Class B loan licence pathway. Forms MD-8 and MD-10 apply to the Class C and Class D loan licence pathway.

4. Are all Class A medical devices required to obtain a manufacturing licence?

No. Class A non-sterile and non-measuring devices covered by G.S.R. 777(E), dated 14 October 2022, are exempt from the specified licensing regime subject to the notification's conditions and must follow the applicable registration requirements.

5. Which authority issues a medical device manufacturing licence?

The State Licensing Authority generally handles eligible Class A and Class B manufacturing licence applications. The Central Licensing Authority handles Class C and Class D manufacturing licence applications under the applicable provisions.

6. Is a Quality Management System required for medical device manufacturing?

The Medical Devices Rules, 2017, specify Quality Management System requirements under the Fifth Schedule. The applicable requirements and verification process depend on the relevant regulatory pathway and device category.

7. What documents are required for a CDSCO manufacturing licence?

The requirements depend on the device and application pathway. They may include applicant and site details, applicable Plant Master File and Device Master File documentation, Quality Management System records, technical documentation, prescribed declarations, and fee records. The current Fourth Schedule and relevant checklist should be consulted.

8. Where can I verify the official CDSCO manufacturing licence requirements?

Refer to the official CDSCO Medical Devices Rules, 2017 page, the applicable amendment notifications, and the current forms and checklists published by CDSCO.

Last Updated : 29 Oct 2026