CDSCO License for Special bevelled needles for implantable vascular access system
Medical Device Information
Intended Use
Power - injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. It is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the needle is also indicated for power injection of contrast media.
Comprehensive Guide to CDSCO Licensing for Special Bevelled Needles for Implantable Vascular Access Systems
Introduction: Understanding Your Device and Regulatory Importance
Special bevelled needles designed for implantable vascular access systems are critical medical devices used for fluid infusion, drug delivery, blood sampling, and power injection of contrast media. These power-injectable, safety non-coring needles reduce the risk of accidental needle-stick injuries and ensure patient safety during vascular access procedures. Given their clinical significance and potential risks, these devices fall under Class C risk category in India’s medical device regulatory framework.
Navigating the Central Drugs Standard Control Organization (CDSCO) licensing process is essential for manufacturers and importers aiming to market these needles in India. Compliance ensures legal market access, patient safety, and alignment with Indian regulatory standards. With over 25 years of experience assisting more than 500 companies, we understand the nuances of CDSCO licensing for such specialized devices.
CDSCO Regulatory Framework for Special Bevelled Needles
India classifies medical devices into four risk classes (A, B, C, D). Special bevelled needles for implantable vascular access systems are Class C devices due to their invasive nature and potential risk if misused. Class C devices require a Central Licensing Authority (CLA) approval, and the relevant manufacturing license is the MD9 license.
The regulatory framework mandates:
- Compliance with the Medical Device Rules, 2017
- Submission of detailed technical documentation
- Product testing by CDSCO-approved laboratories
- Audits by CDSCO inspectors
- Ongoing compliance with quality management systems (ISO 13485:2016)
For detailed classification, manufacturers can refer to the Medical Device Classification guide.
Risk Classification and License Requirements for Class C Devices
Being a Class C device, the Special bevelled needle requires an MD9 manufacturing license. This license is issued by the CDSCO Central Licensing Authority and involves a more rigorous evaluation than Class A or B devices.
Key points:
- Requires prior test license (MD13) before manufacturing
- Product testing at CDSCO-recognized labs is mandatory
- Comprehensive technical documentation must be submitted
- On-site audit by CDSCO inspectors
Manufacturing License Process (MD9) for Class C Devices
The MD9 licensing process is structured as follows:
- Test License Application (Form MD13): Before full-scale manufacturing, apply for a test license to produce a limited batch for testing.
- Product Testing: Submit samples to government-approved testing laboratories. Refer to the list of testing laboratories for accredited labs.
- Document Preparation: Compile a detailed dossier including Device Master File, Plant Master File, risk management files, quality management system documentation, and certificates.
- Application Submission (Form MD7): Apply for the MD9 license through the CDSCO MD Online Portal.
- Audit: CDSCO inspectors conduct a thorough audit of manufacturing facilities and quality systems.
- Query Resolution: Address any queries or deficiencies raised by the department or during audit.
- Grant of License: Upon successful review and compliance, the MD9 license is granted.
For a step-by-step guide, see our MD9 License Guide.
Manufacturing License Documents Required for Special Bevelled Needles
The documentation package is critical to demonstrating compliance. For Class C devices like your special bevelled needles, you must submit:
- Company Constitution and Registration Certificates
- Proof of ownership/lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design, specifications, manufacturing process (Guide here)
- Plant Master File (PMF): Description of manufacturing facilities and quality control systems (Guide here)
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File aligned with ISO 14971 standards (Risk Management Details)
- Test Reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 certificate)
Import License Process (MD15) for Class C Devices
If you are an importer of these needles, a separate import license (Form MD14 for application, license issued on MD15) is required from the CDSCO Central Licensing Authority.
The process includes:
- Compilation of required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Submission of application via the CDSCO MD Online Portal
- Query resolution and review period
- Grant of MD15 license allowing import and distribution in India
Typical timelines range between 5-6 months.
Import License Documents Required
- Manufacturing License of the device from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
For your Class C special bevelled needles, expect the following approximate timelines:
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| MD9 License Application | 4 to 5 months total |
Overall, from test license initiation to MD9 license grant, the process spans around 4-5 months. Import license (MD15) can take 5-6 months.
Government Fees and Costs
- MD9 Manufacturing License: ₹50,000 per application + ₹1,000 per product
- Test License (MD13): Fees vary, typically included in the application
- Import License (MD15): Fees depend on risk class; for Class C & D, approximately 1,500 per product
These fees exclude costs for product testing, audit preparation, and document consultancy.
Common Challenges and Practical Solutions
Challenge 1: Delays in product testing due to sample rejection or lab backlogs.
- Solution: Pre-validate your samples and select testing labs with shorter turnaround times from the CDSCO Testing Laboratories list.
Challenge 2: Incomplete or inconsistent documentation leading to audit non-compliance.
- Solution: Use templates and checklists based on CDSCO guidelines and consult experts to prepare your Device Master File, Plant Master File, and Risk Management File.
Challenge 3: Addressing audit queries can be time-consuming.
- Solution: Maintain transparent communication with CDSCO and conduct pre-audit internal assessments.
Challenge 4: Complexities in manufacturing site compliance.
- Solution: Engage notified bodies early for guidance. See the list of notified bodies authorized for audits.
Expert Consultation and Support
With over 25 years of experience and 500+ successful CDSCO license applications, our team provides tailored support for Class C medical devices like special bevelled needles. We assist in:
- Gap analysis and compliance strategy
- Documentation preparation and review
- Test sample coordination with approved labs
- Liaison with CDSCO and notified bodies
- Training for audit readiness
Our goal is to minimize delays, reduce rejections, and ensure your device reaches Indian patients safely and swiftly.
Getting Started with Your CDSCO License Application
To initiate your CDSCO licensing journey for Special bevelled needles:
- Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with application forms.
- Prepare Test License (MD13) Application: Gather initial documents and apply for a test license to manufacture samples.
- Identify and Coordinate with Approved Testing Labs: Start product testing early to avoid bottlenecks.
- Compile Comprehensive Documentation: Use our expert templates for DMF, PMF, Risk Management, and QMS files.
- Plan for CDSCO Audit: Ensure your manufacturing site and processes are audit-ready.
- Submit MD9 Application: Once testing and documentation are in place, file your manufacturing license application.
- Engage Professional Support: Consider expert consultancy to navigate queries and expedite approvals.
For more insights and assistance, explore our detailed MD9 License Guide and start your application process today.
By understanding the regulatory landscape and following these practical steps, manufacturers and importers of special bevelled needles for implantable vascular access systems can confidently achieve CDSCO compliance, ensuring safe and efficient patient care across India.
