CDSCO License for Auto-disable (AD) syringes for immunization
Medical Device Information
Intended Use
Intend to inject fluids into or withdraw fluids from the body.
Comprehensive Guide to CDSCO Licensing for Auto-disable (AD) Syringes – Class B Disposable Hypodermic Syringes
Auto-disable (AD) syringes play a crucial role in immunization programs by preventing reuse and ensuring patient safety. As a Class B medical device under CDSCO regulations, manufacturers and importers must navigate a defined regulatory pathway to legally market these syringes in India. With over 25 years of experience helping 500+ companies secure CDSCO licenses, we provide a detailed, practical roadmap tailored specifically for Auto-disable syringes to streamline your compliance journey.
Understanding the CDSCO Regulatory Framework for Auto-disable Syringes
The Central Drugs Standard Control Organisation (CDSCO) classifies Auto-disable syringes as Class B devices due to their moderate risk profile. This classification is informed by the device’s intended use—injecting or withdrawing fluids from the body—and the potential impact on patient safety if the device malfunctions. The relevant notification governing this device is Notification No. 29/Misc/3/2017-DC (292), dated 06.06.2018, which sets forth the regulatory requirements for disposable hypodermic syringes.
Compliance with CDSCO’s framework ensures product safety, performance, and quality, providing confidence to healthcare providers and end-users. It also facilitates market access across India.
Risk Classification and License Requirements for AD Syringes
As a Class B device, Auto-disable syringes require an MD5 manufacturing license, issued by the State Licensing Authority. This contrasts with higher-risk Class C/D devices, which require MD9 licenses granted by the Central Licensing Authority.
Key points:
- Device Risk Class: B
- License Type: MD5 Manufacturing License (Form MD3)
- Authority: State Licensing Authority
- Total Timeframe: Approximately 3-4 months
- Fees: Rs. 5000 (application) + Rs. 500 per product
For importers, the MD15 license is applicable but requires additional certifications.
Step-by-Step Manufacturing License Process (MD5) for Auto-disable Syringes
The MD5 license process is comprehensive and involves multiple stages to ensure compliance:
Test License Application (Form MD13): Before manufacturing, companies must obtain a test license for the device. This initial approval takes about 1.5-2 months.
Product Testing: Conduct mandatory product testing at CDSCO-approved government labs to verify safety and efficacy. You can find the list of testing laboratories authorized by CDSCO.
Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation.
License Application Submission (Form MD3): Submit all documents and the application via the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts a thorough audit of your manufacturing facility and quality systems. Refer to the list of notified bodies to select an authorized auditor.
Query Resolution: Address any queries or deficiencies raised by CDSCO or the notified body promptly.
License Grant (Form MD5): Upon satisfactory review, the MD5 manufacturing license is issued.
Essential Documents Required for MD5 License Application
Ensuring your documentation is complete and accurate can save significant time:
- Company Constitution Documents (e.g., Certificate of Incorporation, Partnership Deed)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Proof
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed product specifications, manufacturing processes, and quality controls. Our Device Master File guide offers in-depth insights.
- Plant Master File (PMF): Facility layout, equipment, and quality management details. Learn more with our Plant Master File guide.
- Essential Principles Compliance Checklist
- Risk Management File: Hazard analysis and mitigation strategies aligned with ISO 14971. See our Risk Management guide.
- Test Reports from Approved Labs
- Labels, Packaging, and Instructions for Use (IFU)
- Quality Management System (QMS) Documents: ISO 13485 certification and related procedures
Import License Process (MD15) for Auto-disable Syringes
If you are an importer, the MD15 license is mandatory, issued by the Central Licensing Authority. The process differs as follows:
- No test license required
- Application submitted on Form MD14 via the CDSCO MD Online Portal
- Processing time is typically 5-6 months
- Required documents include Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution
- Fees vary by device class; for Class B devices, expect Rs. 2000 per site and Rs. 1000 per product
For detailed guidance, refer to our Import License guide.
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 2 – 3 weeks |
| Application Submission | Immediate |
| Notified Body Audit | 3 – 4 weeks |
| Query Resolution | 2 – 3 weeks |
| Final License Grant (MD5) | 3 – 4 months total |
Adherence to timelines requires proactive preparation, prompt response to queries, and selecting experienced notified bodies.
Government Fees and Cost Structure
- MD5 Manufacturing License Application Fee: Rs. 5000 per application
- Product-wise Fee: Rs. 500 per product
- Additional Costs: Testing fees at government labs (varies), notified body audit charges (variable), and document preparation support if outsourced
Budgeting for these fees early helps avoid surprises.
Common Challenges and Practical Solutions
Challenge: Delays in obtaining test license due to incomplete documents.
- Solution: Use comprehensive checklists and engage regulatory consultants to ensure document completeness.
Challenge: Non-compliance during notified body audit.
- Solution: Conduct internal pre-audit assessments and implement corrective actions proactively.
Challenge: Slow query responses causing license delays.
- Solution: Assign dedicated personnel for regulatory communication and maintain organized records for quick retrieval.
Expert Consultation and Support
Given the complexity of CDSCO licensing for Class B devices like Auto-disable syringes, expert guidance can expedite approvals and ensure compliance. Our team, with 25+ years of regulatory consulting and over 500 successful CDSCO licenses, offers tailored support—from document preparation to audit readiness and query management.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm your device is Class B using the Medical Device Classification tool.
Initiate Test License Application: Prepare Form MD13 and supporting documents to apply via the CDSCO MD Online Portal.
Plan Product Testing: Select an approved testing laboratory early; refer to the CDSCO list.
Compile Critical Documents: Develop your Device Master File and Plant Master File comprehensively.
Schedule Notified Body Audit: Coordinate audit timing to align with license application submission.
Engage Expert Help: Consider consulting experienced regulatory professionals to streamline the process.
Embarking on your CDSCO licensing journey with these actionable steps ensures a smoother path to market authorization for your Auto-disable syringes. We are here to support you at every stage, leveraging decades of regulatory expertise to secure your success in the Indian medical device market.
