CDSCO License for Implantable infusion pumps with Catheters
Medical Device Information
Intended Use
Intended to treat chronic pain and spasticity patients. The pump is inserted below the ribs and it designed to continually transport medication to the site of action. Doses are accurate, user friendly and the device does not restrict movement.
Comprehensive Guide to CDSCO Licensing for Implantable Infusion Pumps with Catheters (Class D Medical Devices)
As specialists with over 25 years of experience in Indian medical device regulatory affairs, we have successfully guided more than 500 manufacturers and importers through the CDSCO licensing process. Implantable infusion pumps with catheters, classified as Class D devices due to their high-risk nature and critical role in managing chronic pain and spasticity, require meticulous compliance with India's regulatory framework to ensure market authorization.
Understanding Implantable Infusion Pumps with Catheters
These sophisticated devices are surgically implanted below the ribs to deliver precise doses of medication directly to targeted sites, offering significant quality-of-life improvements for chronic pain and spasticity patients. Their continuous infusion capability and user-friendly design underscore their complexity and the necessity for stringent regulatory oversight.
CDSCO Regulatory Framework for Class D Catheter Devices
Implantable infusion pumps fall under the highest risk classification (Class D) according to the Central Drugs Standard Control Organization (CDSCO) guidelines. The regulatory framework mandates a centralized approval process for manufacturing and import licenses, emphasizing patient safety and device effectiveness.
The relevant notification governing this device is 29/Misc/3/2017-DC (18), dated 16.08.2018, which categorizes implantable infusion pumps with catheters under Class D medical devices.
Risk Classification and License Requirements
- Risk Class: D (Highest Risk)
- Manufacturing License: MD9 License (Application Form MD7)
- Import License: MD15 License (Application Form MD14)
- Approving Authority: Central Licensing Authority (CDSCO Headquarters)
Manufacturing License Process for Class D Devices (MD9 License)
The MD9 manufacturing license process is comprehensive and involves multiple stages:
Test License (MD13 Form): Before applying for the manufacturing license, you must obtain a test license. This usually takes 1.5 to 2 months. The test license authorizes product testing in government-approved labs.
Product Testing: Testing must be done at CDSCO-approved laboratories to validate safety and performance. Refer to the list of testing laboratories for approved facilities.
Document Preparation: Comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents, must be prepared.
Application Submission: Submit your application on the CDSCO MD Online Portal using Form MD7 for the MD9 license.
Audit and Inspection: CDSCO inspectors will audit your manufacturing facility and documentation.
Query Resolution: Address any queries raised by CDSCO during the review.
License Grant: Upon successful audit and document verification, the MD9 manufacturing license is granted.
Manufacturing License Documents Required
For implantable infusion pumps with catheters (Class D), the documentation is rigorous to address the device’s critical nature:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Certificates
- Fire and Environmental (Pollution) NOCs
- Device Master File (DMF) – detailed device specifications and design history (Device Master File guide)
- Plant Master File (PMF) – manufacturing processes and quality controls (Plant Master File guide)
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File demonstrating compliance with applicable standards (Risk Management)
- Test Reports from government-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, typically ISO 13485:2016 certification
Import License Process for Class D Devices (MD15 License)
For importers intending to bring implantable infusion pumps with catheters into India, the MD15 import license is mandatory:
Document Preparation: Prepare requisite documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate or equivalent, and Device and Plant Master Files.
Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
Review and Queries: CDSCO reviews documents and may raise queries.
License Grant: After satisfying all requirements, CDSCO issues the MD15 import license.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate indicating the device is approved for sale in the exporting country
- ISO 13485:2016 Certification
- CE Certificate or equivalent international certification
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Incorporation Certificates
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| MD9 Manufacturing License | 4 to 5 months (including test license and audit) |
| MD15 Import License | 5 to 6 months |
It is crucial to plan for the entire licensing process to span approximately 5 to 6 months for Class D devices, considering the complexity and rigorous scrutiny involved.
Government Fees and Costs
| License Type | Fee Structure |
|---|---|
| MD9 License | Rs 50,000 per application + Rs 1,000 per product |
| MD15 Import License | Class D: 1,500 per product |
Additional costs to budget for include product testing fees at approved laboratories, audit-related expenses, and consultancy fees if you engage expert support.
Common Challenges and Solutions
Complex Documentation: Preparing extensive files like Device Master File and Risk Management File can be daunting. Leveraging templates and expert guidance can streamline this process.
Testing Delays: Testing at government-approved labs sometimes experiences backlogs. Early scheduling and choosing labs with shorter queues can mitigate delays.
Audit Queries: Audits often result in multiple rounds of clarifications. Maintaining meticulous records and proactive communication with CDSCO aids in smooth query resolution.
Regulatory Updates: Staying abreast of amendments in notifications and guidelines is critical. Subscribing to official CDSCO updates or engaging consultants ensures compliance.
Expert Consultation and Support
With our extensive experience assisting over 500 companies across India, we provide tailored consulting services to simplify your CDSCO licensing journey. From document preparation to audit readiness and post-approval compliance, our end-to-end support helps you avoid common pitfalls.
Explore our detailed MD9 License Guide and Import License Guide for further insights.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device is Class D as per the official Medical Device Classification.
Initiate Test License Application: Submit Form MD13 for the test license via the CDSCO MD Online Portal.
Engage Approved Testing Labs: Coordinate product testing early to avoid bottlenecks.
Compile Comprehensive Documentation: Assemble your Device Master File, Plant Master File, risk and quality documents.
Prepare for Audit: Schedule and prepare your manufacturing site and QMS for the CDSCO inspection.
Submit MD9 Application: File Form MD7 for manufacturing license upon completion of testing and document readiness.
Plan Import Strategy: If importing, prepare required certifications and submit Form MD14 for the MD15 license.
Starting with a clear roadmap and leveraging expert consultation can significantly reduce time-to-market and ensure regulatory compliance for your implantable infusion pumps with catheters in India.
For personalized assistance or to discuss your specific requirements, contact our regulatory experts today and take the first step toward successful CDSCO licensing.
