What Is Form MD-4 in CDSCO?

Form MD-4 in CDSCO is an official application form used to apply for a loan license to manufacture Class A and Class B medical devices in India. It is part of the Medical Devices Rules, 2017 and is regulated by the Central Drugs Standard Control Organization (CDSCO) India’s national authority for regulating medical devices. A loan license allows a business to manufacture medical devices using another company’s licensed manufacturing facility instead of owning its own production unit.

In this case, the applicant (loan licensee) files Form MD-4, and the owner of the manufacturing facility gives written consent through Form MD-5. Once the application is approved, the licensing authority issues the manufacturing loan license in Form MD-6. Since Class A and Class B medical devices are considered low to moderate risk (like thermometers, surgical gloves, stethoscopes, catheters, syringes), the licensing process is handled by the State Licensing Authority (SLA) rather than the central CDSCO office.

Who Needs to Apply Using Form MD-4 in CDSCO?

You must apply using Form MD-4 if:

• You want to manufacture Class A or Class B medical devices but do not own a manufacturing facility.
• You plan to use another licensed manufacturer’s site for production.
• You are a startup or small-scale business entering medical device manufacturing without investing in infrastructure.
• You are a foreign company partnering with an Indian manufacturing unit to produce Class A/B devices locally.

Why Is Form MD-4 in CDSCO Important?

• Mandatory for Compliance – Without MD-4 approval, manufacturing at another company’s facility is illegal.
• Ensures Quality Standards – Confirms that devices will be produced under ISO 13485-certified facilities with proper quality control.
• Cost-Efficient Entry – Allows businesses to start manufacturing without building a factory.
• Faster Market Access – Shortens the time to start production and sales.
• Shared Accountability – Both the loan licensee and the licensed facility owner are responsible for meeting legal requirements.

Step-by-Step Procedure to Apply for Form MD-4 in CDSCO

S.No.	Action	Details
1.	Classify the Device	Check if your device is Class A or B as per CDSCO’s classification list.
2.	Register on SUGAM Portal	Create an account and register your organization with the CDSCO’s official online portal.
3.	Prepare Documentation	Collect Device Master File (DMF), Site Master File (SMF), ISO 13485 certificate, and plant layout.
4.	Obtain MD-5 Consent	Get written consent from the licensed manufacturer whose facility you will use.
5.	Fill Form MD-4 Online	Enter applicant details, device information, and site details.
6.	Pay Application Fee	Pay the prescribed fee via Bharatkosh and attach proof.
7.	Upload Documents	Submit all required documents digitally signed on the portal.
8.	Authority Review	SLA reviews the application; may raise queries for clarification.
	Inspection (If Needed)	An on-site inspection may be conducted to verify compliance.
	Grant of License	If approved, SLA issues Form MD-6 Loan License.

Documents Required for Form MD-4 Application

Here we have mentioned the important documents that are required for MD 4

• Covering Letter
• Duly filled Form MD-4
• Form MD-5 (Consent from licensed manufacturer)
• ISO 13485 Certificate
• Device Master File (DMF)
• Site Master File (SMF)
• Plant Layout & Equipment List
• Proof of Premises Ownership / Lease Agreement (for the licensed facility)
• Declaration of compliance with Medical Device Rules, 2017
• Power of Attorney / Authorization Letter (if applicable)
• Fee Receipt (Bharatkosh)
• Additional documents requested by the State Licensing Authority

Difference Between MD-3, MD-4, MD-5, and MD-6 Forms

S.No.	Form	Purpose	Device Class	License Issued
1.	MD 3	Own manufacturing license application	Class C & D	MD-5 (License)
2.	MD 4	Loan license application	Class A & B	MD-6 (Loan License)
3.	MD 5	Consent letter from licensed manufacturer	Class A & B	–
4.	MD 6	Loan license issued after MD-4 approval	Class A & B	–

Common Challenges in Form MD-4 Applications

• Incorrect device classification.
• Missing or incomplete DMF or SMF.
• No valid Form MD-5 consent.
• Non-compliance with ISO 13485 requirements.
• Delay in responding to SLA queries.
• Errors in portal filing.

How Can ELT Corporate Help You With Form MD-4 in CDSCO?

ELT Corporate offers expert assistance for businesses applying for Form MD-4 in CDSCO.

• Device classification guidance for Class A & B devices
• Preparation of DMF and SMF
• Drafting and reviewing Form MD-4 and MD-5
• Filing the application on the SUGAM portal
• Liaison with the State Licensing Authority
• Assistance during inspections
• Query and deficiency handling
• Renewal and license modification support

With ELT Corporate, you can ensure a smooth, fast, and compliant loan license approval.