CDSCO License for Irrigating Syringes
Medical Device Information
Intended Use
cleaning debris away from the area the dentist is working on
Comprehensive Guide to CDSCO Licensing for Irrigating Syringes (Class B)
As seasoned regulatory consultants with over 25 years of expertise and more than 500 successful CDSCO license approvals, we understand the intricacies of medical device regulation in India. This guide specifically addresses the regulatory pathway for Irrigating Syringes, a Class B disposable hypodermic syringe used to clean debris during dental procedures, notified under 29/Misc/3/2017-DC (292) dated 06.06.2018.
Understanding Irrigating Syringes and Regulatory Importance
Irrigating syringes play a critical role in dental care by efficiently cleaning debris from the working site, ensuring infection control and patient safety. Given their direct application in invasive procedures, Indian regulatory authorities classify them as Class B medical devices, requiring adherence to specific safety and quality standards before marketing.
Securing a CDSCO license for manufacturing or importing these syringes is mandatory to comply with the Medical Device Rules, 2017 and avoid legal complications, shipment holds, or market bans.
CDSCO Regulatory Framework for Irrigating Syringes
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacturing of medical devices in India. For Class B devices like irrigating syringes, the licensing authority is the State Licensing Authority, operating under the CDSCO's guidelines.
The key license for manufacturing such devices is the MD5 license, issued after a comprehensive process involving testing, audit, and document verification. Importers require an MD15 license from the Central Licensing Authority.
For more on device classification, refer to our detailed Medical Device Classification guide.
Risk Classification and License Requirements for Irrigating Syringes
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Issuing Authority: State Licensing Authority
- Total Timeline: Approximately 3-4 months
- Key Steps: Test license (MD13) → Testing by notified lab → Documentation → Audit by notified body → License grant
Manufacturing License Process (MD5) for Irrigating Syringes
The manufacturing license process is multi-staged:
Test License Application (Form MD13): Before manufacturing, apply for the test license allowing product testing. This phase typically takes 1.5 to 2 months.
Product Testing: Submit samples to government-approved testing laboratories. Testing ensures compliance with Indian standards and product safety.
Document Preparation: Compile technical documentation including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
License Application (Form MD3): Apply for the MD5 license on the CDSCO MD Online Portal.
Audit by Notified Body: An audit of manufacturing facilities and QMS is conducted by a notified body listed on the CDSCO Notified Bodies list.
Query Resolution: Address any observations raised during audit or by the licensing authority promptly.
Grant of License (Form MD5): Upon satisfactory audit and review, the manufacturing license is granted.
For an in-depth overview, see our MD5 License Guide.
Manufacturing License Documents Required for Irrigating Syringes
To meet CDSCO requirements, submit the following:
- Company Constitution documents (Incorporation Certificate, PAN, GST registration)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File detailing product specifications (Learn more)
- Plant Master File describing manufacturing processes and controls (Guide here)
- Essential Principles Checklist conforming to Indian Medical Device Rules
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System documents (ISO 13485 compliant preferred)
Import License Process (MD15) for Irrigating Syringes
For importers of irrigating syringes, the license required is MD15, obtained from CDSCO Central Licensing Authority. The process generally takes 5-6 months and involves:
- Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Submission of application on CDSCO MD Online Portal
- Review and queries resolution
- Grant of MD15 Import License
More details can be found in our Import License Guide.
Import License Documents Required
- Valid foreign manufacturing license
- Free Sale Certificate from country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale Drug License
- Company Constitution documents
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 2 - 3 weeks |
| Audit by Notified Body | 2 - 3 weeks |
| Query Resolution and Review | 2 - 4 weeks |
| Total MD5 License Time | ~3 to 4 months |
These timelines are averages; proactive document preparation and prompt query responses can shorten the process.
Government Fees and Costs
MD5 License:
- Application fee: ₹5,000
- Per product fee: ₹500
Test License (MD13): Included in overall process costs
Additional costs may include fees for testing, notified body audits, and consultancy services.
Budget planning should account for these to avoid delays.
Common Challenges and Solutions
Incomplete Documentation: Many applicants face delays due to missing or improperly formatted documents. Utilize checklists and expert reviews.
Delayed Testing: Scheduling and sample preparation for government-approved labs can extend timelines. Plan sample submissions early.
Audit Non-Compliance: Facilities may not meet notified body requirements initially. Pre-audit assessments can identify gaps.
Slow Query Responses: Delayed replies to CDSCO queries prolong licensing. Assign dedicated teams for communication.
Our hands-on experience helps clients navigate and resolve these issues efficiently.
Expert Consultation and Support
With our extensive track record, we provide:
- Detailed gap analysis and document preparation
- Liaison with notified bodies and testing labs
- End-to-end project management from test license to final approval
- Training on compliance and QMS implementation
Partnering with experts reduces risk and accelerates market entry.
Getting Started with Your CDSCO License Application for Irrigating Syringes
- Assess Classification: Confirm your product falls under Class B.
- Prepare Initial Documents: Gather company, technical, and facility documents.
- Apply for Test License (MD13): Submit on the CDSCO MD Online Portal.
- Coordinate Testing: Send samples to approved labs listed on the Testing Laboratories Directory.
- Compile Technical Files: Develop Device Master File, Plant Master File, Risk Management, and QMS documents.
- Schedule Notified Body Audit: Select a notified body from the official List of Notified Bodies.
- Submit MD5 License Application: Apply using Form MD3 on the CDSCO portal.
- Monitor and Respond: Address queries promptly.
Starting early and following this roadmap will streamline your compliance journey for irrigating syringes in India.
For tailored assistance, reach out to our regulatory experts who have guided over 500 companies through this exact process.
By adhering to these guidelines and leveraging expert support, manufacturers and importers of irrigating syringes can successfully navigate the CDSCO licensing landscape and bring their products to the Indian market efficiently and compliantly.
