CDSCO License for Injector Type actuator syringe
Medical Device Information
Intended Use
A syringe actuator for an injector is an electrical device that controls the timing of an injection by an angiographic or indicator injector and synchronizes the injection with the electrocardiograph signal.
Comprehensive Guide to CDSCO Licensing for Injector Type Actuator Syringe (Class C Medical Device)
As specialists with over 25 years of experience and having supported 500+ companies in successful CDSCO licensing, we understand the nuances of regulatory compliance for medical devices like the Injector Type Actuator Syringe. This device, classified as Class C under India's medical device regulations, requires meticulous attention to the CDSCO licensing process to ensure timely market entry.
Understanding the Injector Type Actuator Syringe and Its Regulatory Importance
An Injector Type Actuator Syringe is an electrical device designed to control the timing of injections during angiographic or indicator procedures, synchronizing them with electrocardiograph signals. Classified under Disposable Hypodermic Syringes, it plays a critical role in diagnostic imaging procedures, demanding high safety and performance standards. Given its classification as Class C, the device involves a moderate to high risk, necessitating stringent regulatory oversight.
CDSCO Regulatory Framework for Class C Medical Devices
The Central Drugs Standard Control Organization (CDSCO) governs all medical device approvals in India. For Class C devices like the Injector Type Actuator Syringe, the licensing authority is the Central Licensing Authority, and the applicable manufacturing license is the MD9 license, filed through Form MD7.
Manufacturers must comply with the Medical Device Rules, 2017, and follow a detailed process involving product testing, documentation, audit, and finally, license grant.
Risk Classification and License Requirements for Injector Type Actuator Syringe
The risk classification system by CDSCO categorizes devices into Class A, B, C, and D based on risk. Class C devices, such as this actuator syringe (Notification 29/Misc/3/2017-DC (292) dated 06.06.2018), require a manufacturing license under MD9, handled centrally.
This classification dictates the following:
- License Type: MD9 (Application Form MD7)
- Authority: Central Licensing Authority (CDSCO HQ)
- Total Processing Time: Approximately 4-5 months
- Government Fees: Rs 50,000 per application + Rs 1,000 per product
Detailed Manufacturing License Process (MD9) for Class C Devices
Test License Application (Form MD13):
- Before the manufacturing license, obtain a test license allowing product testing.
- Processing time: 1.5-2 months.
- Mandatory to get the device tested in CDSCO-approved laboratories.
Product Testing:
- Testing must be conducted at government-recognized labs listed on the CDSCO Testing Laboratories page.
- Tests focus on safety, electrical compliance, and performance aligned with the device’s intended use.
Document Preparation:
- Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), and Risk Management File.
- Follow our expert Device Master File guide and Plant Master File guide for best practices.
Submission of Manufacturing License Application (Form MD7):
- Apply through the CDSCO MD Online Portal.
- Ensure all forms, fees, and documents are complete to avoid delays.
CDSCO Audit:
- Central CDSCO inspectors conduct audits of manufacturing facilities and QMS.
- Audit includes verification of compliance with Essential Principles and Risk Management requirements.
Queries and Clarifications:
- Timely responses to any queries from CDSCO or auditors are critical to avoid processing delays.
Grant of Manufacturing License (Form MD9):
- Upon satisfactory audit and documentation review, the license is granted.
Manufacturing License Documents Required for MD9
- Company Constitution (e.g., Memorandum of Association, Articles of Association)
- Proof of ownership or valid lease agreement of manufacturing premises
- Documents evidencing technical personnel qualifications and experience
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating conformity with ISO 14971 principles
- Product test reports from CDSCO-approved laboratories
- Product labels, packaging, and Instructions for Use (IFU)
- Quality Management System documentation (preferably ISO 13485:2016 certified)
Import License Process (MD15) for Injector Type Actuator Syringe
For importers, an MD15 license is mandatory before marketing the device in India.
- Authority: Central Licensing Authority
- Application Form: MD14
- Process Duration: Approximately 5-6 months
- Documentation: Manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, Wholesale License, Company Constitution
- Government Fees:
- Class C devices: Rs 3,000 per site + Rs 1,500 per product
You can apply for the import license through the CDSCO MD Online Portal.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Documentation Preparation | 1 month |
| Manufacturing License (MD9) | 1.5 – 2 months |
| Total Estimated Time | 4 – 5 months |
Government Fees and Costs
- Test License (MD13): Approx Rs 5,000
- Manufacturing License (MD9):
- Rs 50,000 per application
- Rs 1,000 per product
Budgeting for third-party audits, testing costs, and consultancy support is vital to avoid unexpected expenses.
Common Challenges and Practical Solutions
- Delay in Test Reports: Coordinate closely with approved labs and choose facilities with proven turnaround times.
- Incomplete Documentation: Use detailed checklists and professional guidance to ensure all documents meet CDSCO requirements.
- Audit Non-compliance: Conduct internal pre-audits and staff training to prepare for CDSCO inspections.
- Query Resolution Delays: Assign a dedicated regulatory liaison to promptly address CDSCO queries.
Expert Consultation and Support
Navigating the MD9 licensing process for a Class C device like the Injector Type Actuator Syringe can be complex. Our extensive experience and proven methodology streamline your application, reducing time and compliance risks. We provide end-to-end support—from document preparation and testing coordination to audit readiness and query management.
Getting Started with Your CDSCO License Application
Assess Device Classification and Confirm Requirements: Verify your device is Class C as per the Medical Device Classification.
Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal.
Schedule Product Testing: Engage with CDSCO-recognized testing laboratories early.
Prepare Comprehensive Documentation: Utilize our Device and Plant Master File guides to compile robust files.
Apply for Manufacturing License (MD9): Submit Form MD7 with all supporting documents.
Prepare for Audit: Conduct internal audits and ensure all compliance measures are implemented.
Engage with CDSCO: Respond promptly to any queries or requests for clarifications.
By following this roadmap, manufacturers and importers can efficiently navigate CDSCO requirements for the Injector Type Actuator Syringe and ensure compliance with Indian regulatory standards. For personalized assistance and end-to-end regulatory support, feel free to reach out to our expert team.
For further reading and resources, explore our detailed MD9 License Guide and stay updated with the latest on Notified Bodies for Audits.
