CDSCO License for Syringe pump
Medical Device Information
Intended Use
A mains electricity (AC-powered) device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries that allow the device to operate for a short period of time when no line power is available (e.g., during transport or a power outage).
Comprehensive Guide to CDSCO Licensing for Syringe Pumps (Class C Medical Device)
Syringe pumps are critical medical devices widely used in pediatrics and neonatology for precise, controlled infusion of small volumes of medication. These AC-powered pumps deliver high accuracy infusion rates essential for neonatal and critical care settings, making regulatory compliance a top priority for manufacturers and importers. With over 25 years of experience and having supported 500+ companies in navigating the Indian regulatory landscape, we provide you with a detailed roadmap to obtain your CDSCO license for this Class C medical device.
Understanding the CDSCO Regulatory Framework for Syringe Pumps
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Syringe pumps, classified as Class C devices due to their critical function and risk profile, require central licensing through the CDSCO.
Your device falls under the notified category with File No. 29/MiscJ03/2020-DC (150), dated 23.08.2021, confirming its regulatory classification and applicable standards.
Risk Classification and License Requirements for Syringe Pumps
The MDR classifies medical devices into four risk classes:
- Class A (Low risk)
- Class B (Low-moderate risk)
- Class C (Moderate-high risk)
- Class D (High risk)
Syringe pumps are Class C devices due to their critical role in drug delivery in vulnerable populations.
For Class C devices, the required manufacturing license is the MD9 license, issued by the Central Licensing Authority. The import license is the MD15 license, also issued centrally.
Manufacturing License Process (MD9) for Syringe Pumps
The MD9 licensing process is comprehensive and includes the following steps:
Test License (Form MD13): Obtain a test license first, which allows limited manufacture for testing and validation. This takes approximately 1.5 to 2 months.
Product Testing: Syringe pumps must be tested in government-approved labs to verify compliance with safety and performance standards. Refer to the list of Testing Laboratories recognized by CDSCO.
Document Preparation: Compile all required documentation, including Device Master File, Plant Master File, risk management files, and QMS documents.
Application Submission (Form MD7): Submit your complete application for the MD9 license on the CDSCO MD Online Portal.
Inspection and Audit: CDSCO inspectors will conduct an on-site audit to verify compliance with MDR and QMS requirements.
Query Resolution: Address any queries raised by CDSCO during the review.
Grant of License (Form MD9): Upon successful completion, you will receive your manufacturing license.
Manufacturing License Documents Required for Syringe Pumps
Ensure your submission includes:
- Company Constitution and Incorporation Documents
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing process (Learn more about DMF)
- Plant Master File (PMF) describing your manufacturing facilities and quality controls (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with MDR
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documentation (typically ISO 13485:2016 compliant)
Import License Process (MD15) for Syringe Pumps
Importers of syringe pumps into India must secure an MD15 license through the CDSCO Central Licensing Authority. The process includes:
Document Compilation: Prepare manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, and master files.
Application Submission (Form MD14): Apply via the CDSCO MD Online Portal.
Review and Query Resolution: CDSCO reviews the application and raises queries if needed.
License Grant (Form MD15): After satisfactory review, the import license is issued.
Note: For import licenses, no test license is required.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate from the competent authority
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| License Type | Duration (Approximate) |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Manufacturing License (MD9) | 4 - 5 months (including test license, testing, audit) |
| Import License (MD15) | 5 - 6 months |
The entire MD9 process includes the test license stage; hence, plan accordingly to accommodate these timelines.
Government Fees and Costs
For the MD9 manufacturing license:
- Application Fee: ₹50,000
- Per Product Fee: ₹1,000
For the MD15 import license:
- Class C Device Fees: 1,500 per product
These fees are payable during application submission via the CDSCO portal.
Common Challenges and Practical Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with testing labs early and confirm sample requirements to avoid resubmissions.
Challenge 2: Document Gaps and Non-Compliance
- Solution: Use detailed checklists and consult guides on Device Master Files and Risk Management to ensure comprehensive documentation.
Challenge 3: Audit Non-Conformities
- Solution: Conduct internal audits and gap analyses before CDSCO inspection to preempt potential findings.
Challenge 4: Query Resolution Delays
- Solution: Assign dedicated regulatory personnel to respond promptly and thoroughly to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing for Class C devices like syringe pumps demands expertise. Our 25+ years of regulatory consultancy ensures:
- Tailored guidance on documentation and compliance
- Liaison with notified bodies and testing labs
- End-to-end application management
- Training on MDR compliance and QMS implementation
Getting Started with Your CDSCO License Application for Syringe Pumps
Assess Your Device Classification: Confirm your device as Class C using the Medical Device Classification guide.
Prepare Your Test License Application (MD13): Gather required documents and submit through the CDSCO MD Online Portal.
Coordinate Product Testing: Send samples to CDSCO-recognized labs (Testing Laboratories).
Compile Complete Documentation: Develop your Device Master File, Plant Master File, Risk Management File, labels, IFU, and QMS documentation.
Engage with Notified Bodies and CDSCO Auditors: Prepare for audits by reviewing the list of notified bodies and aligning your quality systems accordingly.
Submit Your MD9 License Application: Complete and submit Form MD7 via the CDSCO portal.
Respond to Queries Promptly: Maintain open communication channels with CDSCO for efficient resolution.
By following this structured approach and leveraging expert support, you can confidently navigate the CDSCO licensing process and bring your syringe pump to the Indian market with compliance and efficiency.
For detailed insights and consultancy, contact us to leverage our extensive regulatory expertise and ensure your success in the Indian medical device market.
