The MD-9 Form of CDSCO is an official application form used to apply for a license to manufacture Class C and Class D medical devices in India. It is regulated under the Medical Devices Rules, 2017, by the Central Drugs Standard Control Organisation (CDSCO).
In simple terms, a loan license means that when a manufacturer does not own a facility but wants to manufacture Class C or D devices by using another licensed manufacturer’s premises. For this, the applicant must apply through the MD-9 Form.
Since Class C and D medical devices (like MRI machines, ventilators, pacemakers, etc.) are considered high-risk, the CDSCO requires strict procedures and approvals before allowing production.
Thus, understanding the MD-9 Form of CDSCO is very important for manufacturers and businesses planning to enter the Indian medical device market.
Who Needs to Apply Using MD-9 Form of CDSCO?
- Businesses that want to manufacture Class C and Class D medical devices without owning their own factory.
- Manufacturers seeking a loan license to produce devices at another licensed site.
- Indian companies are collaborating with foreign device makers to manufacture in India.
Why Is the MD-9 Form Important?
- Legal Requirement – Mandatory for manufacturing under a loan license.
- Regulatory Compliance – Ensures safety and quality of Class C & D devices.
- Accountability – Both the applicant and the main license holder are responsible.
- Market Access – Without MD-9 approval, manufacturing cannot legally start.
Step-by-Step Procedure to Apply for the MD-9 Form of CDSCO
To apply for the MD-9 Form of CDSCO, manufacturers must follow a structured process:
- Classify Your Device – Check if your medical device falls under Class C or Class D (high-risk). Only these require an MD-9 loan license.
- Register on the SUGAM Portal – Create an account on the CDSCO’s official online portal for filing applications.
- Prepare Documentation – Collect required documents such as Device Master File (DMF), Site Master File (SMF), ISO 13485 Certificate, and loan license agreement (MD-10 Form).
- Fill MD-9 Form Online – Enter details of the applicant, devices, and the licensed manufacturer’s facility you want to use.
- Pay Government Fees – Submit the prescribed application fee through the Bharatkosh portal and upload proof of payment.
- Submit the Application – Upload all documents with digital signatures and submit the form online.
- CDSCO Review – The CDSCO scrutinizes the application and may raise queries if any information is incomplete.
- Inspection – Officials may inspect the manufacturing site to ensure it meets the required standards.
- Approval – If all is in order, the CDSCO issues the MD-11 Loan License, allowing manufacturing at the chosen facility.
What Documents Are Required for MD-9 Form Application?
- Covering Letter
- Form MD-9
- Form MD-10 (Consent Letter)
- ISO 13485 Certificate
- Device Master File (DMF)
- Site Master File (SMF)
- Plant Layout and Equipment List
- Proof of Premises Ownership / Lease Agreement
- Copy of Manufacturing License of the Parent Unit
- Undertaking / Declaration
- Power of Attorney / Authorization Letter
- Fee Receipt (Bharatkosh)
- Other Supporting Documents (if required by CDSCO)
What is the Validity of an MD-9 Form License?
The MD-9 loan license issued by CDSCO is valid for 5 years from the date of issue.
When Should Renewal of the MD-9 License be Done?
Renewal should be applied before the expiry date to avoid cancellation or disruption in manufacturing.
Difference Between MD-3 and MD-9 Form of CDSCO
| S.No. | Form | Purpose | Device Class |
|---|---|---|---|
| 1. | MD-3 | Application for manufacturing license | Class C & D |
| 2. | MD-9 | Application for a loan license to manufacture | Class C & D |
| 3 | MD-11 | License granted after MD-9 approval | Class C & D |
What Are the Common Challenges in MD-9 Form Applications?
- Preparing accurate DMF and SMF
- Ensuring proper loan license agreement (MD-10)
- Fulfilling the infrastructure requirements of Class C & D devices
- Handling CDSCO queries and clarifications
- Avoiding delays due to missing documents
How Can ELT Corporate Help You With the MD-9 Form of CDSCO?
ELT Corporate provides expert guidance for filing the MD-9 Form of CDSCO and obtaining a loan license for Class C & D devices.
Our Services Include:
- Identifying the correct classification of your medical device
- Preparing Device Master File and Site Master File
- Drafting and reviewing MD-9 and MD-10 forms
- Complete support on the SUGAM portal filing
- Handling CDSCO inspections and queries
- Ensuring error-free and timely approvals
- Renewal and post-license modifications support
With ELT Corporate, you can ensure smooth and hassle-free CDSCO registration for your medical device business.
When should I apply for Renewal of my MD-9 License?
You should apply before the expiry date to avoid cancellation.
What Documents are Needed for Renewal?
Updated ISO 13485 certificate, DMF, SMF, compliance reports, and a copy of the existing license.
Comments are closed