What is the License for Manufacturing Syringes?

To manufacture syringes in India, you must have a proper license from the CDSCO. Syringes are medical devices that go directly into the body, so they must meet strict safety and quality rules. A manufacturing license ensures that the syringes are made in a clean, safe, and approved environment.

Whether you are starting a new plant or expanding your product line, getting a Medical Device License for Manufacturing Syringes is a legal requirement. It also helps you gain trust in the market, sell your products across India, and even export globally.

Without this license, making or selling syringes is not allowed and can lead to penalties under the Drugs and Cosmetics Act, 1940.

Why is a Medical Device Manufacturing License for Syringes Important?

Getting a Medical Device License for Manufacturing Syringes is important because:

• It allows you to legally manufacture and sell syringes.
• It ensures the product is safe for patients and medical staff.
• It is required to follow CDSCO and global quality standards.
• It helps you build a trusted brand in the healthcare industry.
• It is necessary for export approvals in many countries.

What is the Applicable License for Manufacturing Syringes?

Depending on the risk level, syringes are usually Class C or Class D medical devices. You will need the following license types:

S.No.	License Type	Form Number	Issued By	Purpose
1.	Manufacturing License	Form MD-9	State Licensing Authority	To manufacture Class C & D medical devices
2.	Loan License (if using another site)	Form MD-10	State Licensing Authority	To manufacture using a third-party factory
3.	Test License (optional)4	Form MD-12	CDSCO	To make sample syringes for testing

What Documents Are Required for Syringe Manufacturing License?

To apply for the Syringe Manufacturing License, prepare the following documents:

• Company documents (PAN, GST, CIN)
• Factory ownership or rent proof
• Site Master File (SMF)
• Device Master File (DMF)
• List of equipment and machinery
• Qualification & CV of technical staff
• ISO 13485 certificate
• Label and packaging design
• Pollution or environmental clearance (if needed)

What is the Step-by-Step Process to Get the Syringe Manufacturing License?

Follow these steps to get your Medical Device License for Manufacturing Syringes:

1. Identify your device class (Syringes are Class C or D).
2. Prepare required documents like DMF and SMF.
3. Ensure your factory follows ISO 13485 guidelines.
4. Register on the CDSCO SUGAM portal.
5. Submit online application using Form MD-7.
6. Pay the government fee for Class C/D devices.
7. The Licensing Authority will visit your factory for inspection.
8. If all is correct, you will receive the Form MD-9 License.

What is the Timeline to Get the Syringe Manufacturing License?

Here’s an estimated timeline to get the license:

S.No.	Stage	Time Required
1.	Document preparation	2–3 weeks
2.	Application submission	1 week
3.	Inspection & review	4–6 weeks
4.	Final license issuance	1–2 weeks

Total estimated time – 2 to 3 months (may vary slightly by state)

What Are the Rules to Follow After Getting the License?

After receiving the Syringe Manufacturing License, you must follow:

• Maintain ISO 13485 quality standards
• Keep full production and QC records
• Follow proper labeling guidelines
• Inform CDSCO if you change your factory or staff
• Renew your license before expiry

What Are the Common Mistakes to Avoid in Syringe License Applications?

Avoid these errors when applying for the syringe manufacturing license:

• Wrong classification of the device
• Missing or incomplete documents (DMF, SMF)
• Factory not following ISO 13485
• Errors in label or packaging design
• Not responding to CDSCO queries on time

Conclusion

If you want to manufacture syringes in India, getting a Medical Device Manufacturing License is the first and most important step. It helps you run your business legally, gain trust from hospitals and buyers, and grow in both Indian and global markets. With the right documents and expert help, the process becomes smooth and stress-free.

Why Choose ELT Corporate for Syringe Manufacturing License Registration?

If you’re looking for the best regulatory consultancy, then ELT Corporate is your trusted partner for all types of medical device licensing – including syringes. We simplify the entire process and ensure you meet all CDSCO requirements without delays.

• Recognized as the best regulatory consultancy in India
• 2500+ successful license approvals across India
• End-to-end documentation (SMF, DMF, ISO setup)
• Expert guidance on Class C & D medical device licensing
• Assistance in SUGAM registration & form filling
• Pre-inspection support to prepare your factory
• Quick turnaround time with no hidden delays
• Personalized attention to every client