CDSCO License for Hyaluronic acid (cross linked) Pre-filled syringe

Comprehensive Guide to CDSCO Licensing for Hyaluronic Acid (Cross Linked) Pre-filled Syringes – Class C Medical Device

At our consultancy, with over 25 years of experience and having successfully guided 500+ companies through CDSCO licensing, we understand the critical importance of regulatory compliance for medical devices. The Hyaluronic Acid (cross linked) Pre-filled Syringe, classified as a Class C device under the Indian regulatory framework, is primarily intended for intradermal implantation and facial soft tissue augmentation—a high-risk application demanding stringent oversight.

CDSCO Regulatory Framework for Hyaluronic Acid Pre-filled Syringes

Regulated by the Central Drugs Standard Control Organisation (CDSCO), all medical devices in India must adhere to the Medical Device Rules, 2017, enforced since January 1, 2020. As per the notification 29/Misc/3/2017-DC (18) dated 16.08.2018, disposable hypodermic syringes fall under medical device regulations. Given the device is a Class C, it requires a license from the Central Licensing Authority.

Risk Classification and License Requirements for Class C Devices

Class C devices have moderate to high risk to patients and users. Hyaluronic acid pre-filled syringes used for facial augmentation involve tissue implantation, which increases risk classification beyond Class A/B.

For Class C devices, the CDSCO mandates the MD9 manufacturing license, applied via Form MD7, issued by the Central Licensing Authority. Importers must apply for an MD15 import license. This ensures compliance with safety, efficacy, and quality standards.

Manufacturing License Process (MD9) for Hyaluronic Acid Pre-filled Syringes

The MD9 license process is comprehensive and typically takes 4-5 months from start to finish. It involves the following steps:

1. Test License (Form MD13): Initial application for test license takes approximately 1.5-2 months. This permits sample testing of the device.
2. Product Testing: Samples must be tested by CDSCO-approved government laboratories. Refer to the Testing Laboratories list for authorized centers.
3. Document Preparation: Compilation of all necessary technical and quality documentation.
4. License Application (Form MD7): Submission of the manufacturing license application on the CDSCO MD Online Portal.
5. Inspection and Audit: CDSCO inspectors conduct thorough audits of the manufacturing facility and documentation.
6. Query Resolution: Promptly addressing any queries or deficiencies raised by the regulatory body.
7. License Grant (Form MD9): Upon satisfactory compliance, the manufacturing license is granted.

Manufacturing License Documents Required

For your Hyaluronic Acid pre-filled syringes, prepare the following mandatory documentation:

• Company Constitution and Registration Proof
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience Details
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) outlining device specifications and design (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian and international standards
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably compliant with ISO 13485:2016

Import License Process (MD15) for Hyaluronic Acid Pre-filled Syringes

If you are an importer, the MD15 license is mandatory, granted by the Central Licensing Authority. The process generally spans 5-6 months and involves:

• Document preparation including manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files
• Application submission on the CDSCO MD Online Portal
• Resolution of departmental queries
• Final grant of Import License on Form MD15

No test license is required for import licensing.

Import License Documents Required

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 QMS Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Registration Proof

Timeline and Processing Duration

Total estimated duration: 4-5 months.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: ₹50,000 per application
  • Product Fee: ₹1,000 per product

• Test License (MD13): Fee varies, typically included in consultancy

• Import License (MD15):

  • Class C & D: $3,000 per site +$1,500 per product

Note: Fees are subject to periodic revision; always verify on the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge 1: Lengthy product testing delays.

• Solution: Initiate test license and sample submission promptly to avoid bottlenecks.

Challenge 2: Incomplete documentation causing audit failures.

• Solution: Use detailed checklists and expert consultation to ensure completeness.

Challenge 3: Difficulty in audit scheduling.

• Solution: Maintain continuous readiness and engage with notified bodies early. Check the List of Notified Bodies for accredited agencies.

Challenge 4: Query responses delayed due to lack of technical clarity.

• Solution: Keep a dedicated regulatory liaison to address queries promptly and accurately.

Expert Consultation and Support

With our extensive experience in CDSCO licensing, we provide:

• End-to-end documentation support including DMF and PMF preparation
• Guidance on risk management and QMS implementation
• Liaison with CDSCO and notified bodies
• Audit readiness and mock inspections
• Timely submission and query handling

We have successfully enabled over 500 companies to register their medical devices, including high-risk injectable devices like Hyaluronic Acid pre-filled syringes.

Getting Started with Your CDSCO License Application

1. Evaluate your device classification: Confirm Class C status using resources like the Medical Device Classification guide.
2. Register on the CDSCO MD Online Portal: Start your application process at CDSCO MD Online Portal.
3. Engage a Notified Body: Early coordination with accredited bodies is essential for audit.
4. Prepare your Device and Plant Master Files: Leverage our expert guides for comprehensive documentation.
5. Plan for Product Testing: Submit samples promptly to approved laboratories.
6. Compile Complete Documentation: From company registration to QMS, ensure all files are ready.
7. Apply for Test License (Form MD13): Proceed to initiate the test license.
8. Submit Manufacturing License Application (Form MD7): Once testing and documentation are complete.

By following these steps and leveraging expert support, your Hyaluronic Acid pre-filled syringe can enter the Indian market with full regulatory compliance, safeguarding patient safety and your business success.

For personalized assistance, feel free to contact our regulatory experts to navigate the complexities of CDSCO licensing efficiently.