CDSCO License for Prefillable Glass Barrel with needle
Medical Device Information
Intended Use
Intended for the automatic self- administration of drugs and biologics from standard Glass Barrel.
Comprehensive Guide to CDSCO Licensing for Prefillable Glass Barrel with Needle (Class B Medical Device)
At our consultancy, with over 25 years of experience and having supported more than 500 manufacturers and importers, we understand the nuances and critical steps involved in securing CDSCO licenses for medical devices like the Prefillable Glass Barrel with Needle. This device, classified as Class B under CDSCO regulations, is essential for the automatic self-administration of drugs and biologics using a standard glass barrel. Its inclusion under Disposable Hypodermic Needles, notified under 29/Misc/3/2017-DC (292) dated 06.06.2018, demands meticulous compliance to ensure market access in India.
CDSCO Regulatory Framework for Prefillable Glass Barrel with Needle
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India. As per the Medical Device Rules 2017, devices are categorized from Class A (low risk) to Class D (high risk). The Prefillable Glass Barrel with Needle falls under Class B (low moderate risk), which means it requires a manufacturing license (MD5) from the State Licensing Authority.
Navigating this framework requires understanding the specific license types, testing mandates, and audit protocols designed for Class B devices.
Risk Classification and License Requirements
Device: Prefillable Glass Barrel with Needle
Risk Class: B (Low Moderate Risk)
License Required: MD5 Manufacturing License (Form MD3)
Authority: State Licensing Authority
Regulatory Notification: 29/Misc/3/2017-DC (292) dated 06.06.2018
The MD5 license is mandatory for manufacturing Class A and B medical devices. This class involves less regulatory burden compared to Class C/D but still requires rigorous documentation, product testing, and an audit by a notified body.
Manufacturing License Process (MD5)
The process to obtain an MD5 manufacturing license for your Prefillable Glass Barrel with Needle typically unfolds in these stages:
Test License (Form MD13): Apply for a test license to begin manufacturing samples for testing. This usually takes 1.5 to 2 months.
Product Testing: Submit samples to CDSCO-approved testing laboratories for compliance testing.
Document Preparation: Compile all regulatory documents including Device Master File, Plant Master File, Risk Management File, and others.
License Application (Form MD3): Submit the final manufacturing license application.
Audit by Notified Body: Engage with a notified body for the required audit. Refer to the list of notified bodies for authorized auditors.
Query Resolution: Address any inquiries raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon successful audit and query resolution, receive the manufacturing license.
Manufacturing License Documents Required
For Prefillable Glass Barrel with Needle manufacturing, ensure you have the following documents ready:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Details and Qualifications
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) – Detailed specifications and design history (Device Master File Guide)
- Plant Master File (PMF) – Manufacturing facility details (Plant Master File Guide)
- Essential Principles Checklist – Compliance with safety and performance standards
- Risk Management File – Risk analysis and mitigation plans (Risk Management)
- Test Reports from CDSCO-approved labs (Testing Laboratories)
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification recommended)
Import License Process (MD15)
If you plan to import the Prefillable Glass Barrel with Needle, you must apply for an MD15 import license from the Central Licensing Authority. The process differs slightly:
- No test license is required.
- Prepare all relevant documents, including Manufacturing License, Free Sale Certificate, ISO 13485 certification, CE certificate (if applicable), Device and Plant Master Files.
- Submit the application on the CDSCO MD Online Portal.
- The process typically takes 5-6 months.
For a detailed walkthrough, consult our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 4 weeks |
| License Application (MD3) | Immediate upon docs |
| Audit by Notified Body | 4 to 6 weeks |
| Query Resolution and Approval | 3 to 4 weeks |
Total Time for MD5 License: Approximately 3 to 4 months from start to finish.
Government Fees and Costs
- Test License (MD13): No separate fee typically, included in overall process.
- MD5 Manufacturing License Application: Rs 5,000 per application.
- Fee per Product: Rs 500 per product.
- Additional Costs: Testing laboratory fees, notified body audit fees (~Rs 1 to 2 lakhs depending on notified body), and consultancy fees if applicable.
Budget realistically for around Rs 3-4 lakhs in total when including all testing, audits, and administrative expenses.
Common Challenges and Solutions
Challenge 1: Delays in product testing due to limited lab slots.
Solution: Book testing slots well in advance and ensure sample quality to avoid retesting.
Challenge 2: Audit non-compliance due to incomplete documentation.
Solution: Conduct internal pre-audits and leverage expert consultation to verify document completeness.
Challenge 3: Query resolution delays.
Solution: Prepare a dedicated regulatory team to respond promptly with clear, evidence-backed answers.
Challenge 4: Misclassification of device risk leading to incorrect license application.
Solution: Verify device classification using official CDSCO resources or trusted classification guides like Medical Device Classification.
Expert Consultation and Support
Our team has successfully guided over 500 companies through the CDSCO licensing maze. We provide:
- Comprehensive gap analysis for your current documentation.
- Assistance in preparing Device and Plant Master Files.
- Coordination with notified bodies and testing labs.
- End-to-end application submission and query handling.
- Tailored training on Indian regulatory compliance.
Getting Started with Your CDSCO License Application
- Assess Your Product Classification: Confirm the Prefillable Glass Barrel with Needle is Class B.
- Register on the CDSCO MD Online Portal: This is mandatory for all applications.
- Prepare Your Test License Application (Form MD13): Begin manufacturing samples for testing.
- Engage Accredited Testing Labs Early: Identify and book slots with government-approved labs.
- Compile Required Documentation: Use our guides for Device Master File and Plant Master File to ensure completeness.
- Schedule Notified Body Audit: Choose from the list of notified bodies and prepare accordingly.
- Submit Your MD5 License Application (Form MD3): After successful testing and audit.
- Maintain Open Communication: Be responsive to CDSCO queries for smooth processing.
By following this structured approach, manufacturers and importers of Prefillable Glass Barrel with Needle can confidently navigate the regulatory pathway and achieve timely CDSCO license approval, ensuring your products reach the Indian market without unnecessary delays.
