CDSCO License for Hyaluronic acid with Lidocaine (cross linked) Pre-filled syringe
Medical Device Information
Intended Use
It is indicated for the treatment of fine lines and medium sized skin depressions and correcting infraorbital skin depressions via deep injection
Comprehensive Guide to CDSCO Licensing for Hyaluronic Acid with Lidocaine (Cross-Linked) Pre-Filled Syringes
With over 25 years of experience and having assisted more than 500 companies, we understand the rigorous regulatory landscape surrounding medical devices in India. The Hyaluronic Acid with Lidocaine (cross-linked) pre-filled syringe is a Class C disposable hypodermic syringe designed for the treatment of fine lines, medium-sized skin depressions, and infraorbital skin depressions via deep injection. Ensuring compliance through the Central Drugs Standard Control Organization (CDSCO) is critical to successfully market this device in India.
CDSCO Regulatory Framework for Hyaluronic Acid with Lidocaine Pre-Filled Syringes
The CDSCO governs the import and manufacture of medical devices in India under the Medical Device Rules, 2017. Your device falls under Class C, which represents moderate to high risk. Regulatory oversight for such devices is stringent, involving central licensing authority processes to assure safety, efficacy, and quality.
Key notifications include Notification 29/Misc/3/2017-DC (18) dated 16.08.2018, classifying disposable hypodermic syringes appropriately.
Risk Classification and License Requirements
- Device Risk Class: C (Moderate to High Risk)
- Applicable Licenses:
- Manufacturing License: MD9 (Form MD7) obtained from the Central Licensing Authority
- Import License: MD15 (Form MD14) obtained from the Central Licensing Authority
Understanding your device’s classification is paramount. We recommend consulting the Medical Device Classification guide to verify and align your registration strategy.
Manufacturing License Process (MD9) for Class C Devices
Obtaining an MD9 manufacturing license is a multi-step process involving product testing, documentation, and inspections.
- Apply for Test License (MD13): This initial license permits manufacturing for testing purposes. Expect a processing time of 1.5 to 2 months.
- Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list to select an authorized lab.
- Document Preparation: Compile detailed technical documents, including Device Master File, Plant Master File, Risk Management File, Quality Management System (QMS) documents, and Essential Principles Checklist.
- Apply for Manufacturing License (Form MD7): Submit your application via the CDSCO MD Online Portal.
- Audit by CDSCO Inspectors: Your manufacturing site will undergo an audit to verify compliance with Good Manufacturing Practices (GMP).
- Query Resolution: Address any queries or deficiencies raised during the review or audit.
- License Grant: Upon successful compliance, the MD9 license is issued.
The entire process typically takes 4 to 5 months.
Manufacturing License Documents Required
For your Hyaluronic Acid with Lidocaine pre-filled syringe, the following documents are essential:
- Company Constitution and Incorporation Certificate
- Proof of Ownership/Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire Safety NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, components, and manufacturing process. Our Device Master File guide offers in-depth insights.
- Plant Master File describing facility layout, machinery, and equipment (Plant Master File Guide)
- Essential Principles Checklist demonstrating compliance with Indian medical device standards
- Risk Management File aligned with ISO 14971 standards (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions For Use (IFU)
- Quality Management System documentation, preferably compliant with ISO 13485:2016
Import License Process (MD15) for Class C Devices
If you intend to import the Hyaluronic Acid with Lidocaine pre-filled syringe, securing the MD15 import license is mandatory.
- Document Preparation: Compile required documents including manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, and ISO 13485:2016 certification.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Review and Query Resolution: Address any clarifications raised by the CDSCO.
- License Grant: The MD15 license is typically granted within 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate attesting product marketability
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License if applicable
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| Process Step | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation Preparation | 1 month (can overlap testing) |
| Manufacturing License (MD9) | 2 – 3 months (audit + review) |
| Import License (MD15) | 5 – 6 months (end to end) |
Proactive planning and early engagement with CDSCO can help streamline your timeline.
Government Fees and Costs
- MD9 Manufacturing License:
- Application Fees: ₹50,000
- Per Product Fee: ₹1,000
- MD13 Test License:
- Included in overall process fees, usually nominal
- MD15 Import License:
- For Class C devices: ₹3,000 per site
- ₹1,500 per product
Budgeting appropriately for these fees is critical to avoid delays.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all technical and quality documents are complete and compliant. Use checklists and expert reviews.
- Delays in Product Testing: Choose well-equipped and accredited labs from the CDSCO Testing Laboratories list early to avoid bottlenecks.
- Audit Non-Compliance: Conduct internal audits and mock inspections ahead of CDSCO audits.
- Query Management: Respond promptly and thoroughly to CDSCO queries. Maintain a dedicated regulatory liaison.
Expert Consultation and Support
Navigating the CDSCO regulatory process for Class C devices like your Hyaluronic Acid with Lidocaine pre-filled syringe is complex but manageable with the right support. Our team has a proven track record in:
- Preparing robust Device and Plant Master Files
- Coordinating with notified bodies and laboratories
- Managing timelines and regulatory communications
- Ensuring compliance with Indian and international standards
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class C status and regulatory path.
- Prepare Documentation: Begin compiling your Device Master File, Plant Master File, and risk management documentation.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
- Schedule Product Testing: Engage with CDSCO-approved labs early.
- Plan Audit Preparation: Select a notified body or prepare for CDSCO inspection.
- Budget for Fees and Timelines: Allocate resources accordingly.
- Engage Expert Consultants: Leverage expertise to avoid pitfalls and accelerate approval.
Embarking on the regulatory journey with clarity and expert guidance will position your Hyaluronic Acid with Lidocaine pre-filled syringe for successful market entry and sustained growth in India. For personalized support, feel free to reach out to our regulatory consulting team.
