What Is MD-3 Form in CDSCO?

MD-3 Form in CDSCO is an official application form used in India to apply for a manufacturing or loan license for Class C and Class D medical devices. Issued by the Central Drugs Standard Control Organization (CDSCO), this form is part of India’s regulatory system under the Medical Devices Rules, 2017. It ensures that only safe, high-quality, and compliant devices are manufactured in the country.

Class C and D devices are high-to very-high-risk medical devices such as MRI machines, pacemakers, CT scanners, etc. Therefore, manufacturers of these devices must obtain prior approval using the MD-3 Form before starting production.

Who Needs to Apply for the MD-3 Form?

Here we have listed the details that who are required to apply for the MD – 3 form, manufacturers who:

• Want to manufacture Class C or D medical devices.
• We are setting up new manufacturing units.
• Are you applying for a loan license to manufacture at someone else’s facility.
• Need renewal or post-approval changes in the existing license.

Why Is MD-3 Form in CDSCO Important?

Using the MD-3 Form is mandatory because:

• It ensures regulatory compliance for high-risk devices.
• It helps CDSCO monitor device safety, quality, and performance.
• It creates a traceable system of accountability.
• It allows regulated import, export, and use of such devices in India.

What Is the Procedure to File MD-3 Form?

• Classification of Medical Devices – First, check whether your device falls under Class C or Class D (high-risk categories).
• Register on the CDSCO SUGAM Portal – Visit the SUGAM Portal, create an organization profile, and login credentials. Add the manufacturing site and authorized personnel details.
• Prepare Required Documents – Check these documents: Device Master File (DMF), Site Master File (SMF), Plant Layout and Equipment List, ISO 13485 Certificate, QMS Details, and many more.
• Fill the MD 3 Form Online – Log in to your SUGAM account, Select Form MD-3 for “Manufacturing license of Class C or D”. Fill in the product details, facility info, and technical specifications. Upload all supporting documents.
• Pay the Government Fee – Calculate the required application fee based on the number of devices. Make payment through the Bharatkosh portal. Upload the payment receipt on the SUGAM Portal.
• Submit Application – Double-check all entered details and documents. Click on “Submit” to send your application to the CDSCO.
• CDSCO Scrutiny and Query Handling – CDSCO reviews the application and may raise queries or deficiencies. Respond to queries on time through the portal.
• Site Inspection by CDSCO – CDSCO will conduct a physical inspection of the manufacturing facility. Inspectors check quality systems, infrastructure, documentation, and processes.
• Grant of License (Form MD-5) – If everything is found in order, CDSCO issues a Manufacturing License in Form MD-5. You can now legally manufacture and market your Class C or D device in India.

What Documents Are Required for MD-3 Form Application?

• Site Master File
• Device Master File
• ISO 13485 Certificate
• Proof of Ownership/Rent Agreement of Manufacturing Site
• Manufacturing Process Flow Chart
• Product Testing Protocols
• Declaration of Conformity
• Valid Power of Attorney (if applicable)

What is the Validity of MD-3 Form License?

The manufacturing license issued via MD-3 (MD-5 Form) is valid for 5 years unless suspended, cancelled, or surrendered. It must be renewed before expiry to avoid discontinuation.

What Is the Difference Between MD-3 and Other CDSCO Forms?

Here, check the difference between MD 3 and other CDSCO forms:

S.No.	Form	Purpose	Device
1.	MD – 1	Apply for the manufacturing of Class A & B devices	A & B
2.	MD – 3	Apply for the manufacturing of Class C & D devices	C & D
3.	MD – 4	Apply for a loan license for the class C & D devices	C & D (Contract-Based)
5.	MD – 5	Manufacturing License issued upon MD 3 approval	C & D

What Are the Common Mistakes in the MD-3 Form Application?

Here are the common mistakes in the MD 3 form application:

• Uploading incomplete documents
• Using incorrect product classification
• Providing wrong technical specs
• Submitting without ISO 13485 or QMS compliance
• Not responding to CDSCO queries in time

How Long Does CDSCO Take to Process MD-3 Applications?

It usually takes 3–6 months after submission, depending on the completeness of documents and inspection reports. Delays can occur if queries are raised or deficiencies are found.

How Can ELT Corporate Help You With the MD-3 Form in CDSCO?

At ELT Corporate, we assist medical device manufacturers with end-to-end MD-3 Form in CDSCO support to ensure a smooth and error-free process.

• Classification and eligibility guidance
• Complete document preparation and review
• Device Master File and Site Master File creation
• End-to-end support in Sugam Portal
• CDSCO inspection readiness and training
• Liaison with authorities for faster approvals
• Post-approval modification and renewal services
• Expert QMS and ISO 13485 support