CDSCO License for Atherectomy Peripheral Catheter
Medical Device Information
Intended Use
Intended for use in atherectomy of the peripheral vasculature.
Comprehensive Guide to CDSCO Licensing for Atherectomy Peripheral Catheters (Class D)
As a specialized peripheral catheter designed for atherectomy procedures in the peripheral vasculature, the Atherectomy Peripheral Catheter falls under the highest risk classification—Class D—according to the CDSCO medical device framework. With over 25 years of experience assisting more than 500 companies in navigating India’s complex regulatory landscape, we provide you with a detailed, step-by-step overview of securing your CDSCO manufacturing or import license for this advanced medical device.
Understanding the CDSCO Regulatory Framework for Atherectomy Peripheral Catheters
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. This device is notified under Notification number 29/Misc/3/2017-DC (292), dated 06.06.2018, categorizing it explicitly within the Catheters category.
Since Atherectomy Peripheral Catheters are Class D devices, they are considered high-risk devices due to their invasive nature and critical use in vascular procedures. Consequently, obtaining a manufacturing license requires central licensing authority approval following stringent evaluation.
Risk Classification and License Requirements for Class D Devices
Class D devices like the Atherectomy Peripheral Catheter demand an MD9 license, governed by the central licensing authority. The MD9 license application process is rigorous, reflecting the device's critical safety profile. Manufacturers must comply with comprehensive quality, safety, and efficacy standards before market entry.
- License Type: MD9 Manufacturing License (Form MD7)
- Issuing Authority: CDSCO Central Licensing Authority
- Application Submission: Online via CDSCO MD Online Portal
For importers, an MD15 import license is required, which also involves central approval and additional certifications.
Manufacturing License Process for Atherectomy Peripheral Catheters (MD9)
The MD9 licensing process is methodical and can be broken down into the following phases:
- Test License Acquisition (Form MD13): Before full manufacturing license application, obtain a test license. This is mandatory for product testing and audit readiness.
- Product Testing: Conduct product testing at government-approved laboratories. Testing validates device performance and safety.
- Documentation Preparation: Compile extensive documents covering technical, quality, and regulatory aspects.
- MD9 License Application (Form MD7): Submit the manufacturing license application via the CDSCO MD Online portal.
- CDSCO Inspection & Audit: Post-application, the CDSCO inspects manufacturing sites and reviews technical compliance.
- Query Resolution: Respond promptly to any queries or clarifications from CDSCO.
- Grant of License (Form MD9): Once all conditions are met, the MD9 license is granted.
The complete process typically takes 4 to 5 months, assuming timely submissions and audit readiness.
Manufacturing License Documents Required for Class D Devices
For the Atherectomy Peripheral Catheter, the documentation must be thorough and compliant with CDSCO guidelines:
- Company Constitution (Incorporation Certificate, MOA/AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff (qualification and experience certificates)
- Fire and Pollution NOCs
- Device Master File (DMF) outlining device design, manufacturing process, and specifications. Refer to our detailed Device Master File guide for preparation tips.
- Plant Master File (PMF) describing manufacturing facility layout and quality systems. Learn more from our Plant Master File guide.
- Essential Principles Checklist confirming compliance with Indian and international standards
- Risk Management File demonstrating risk assessment and mitigation strategies compliant with ISO 14971. See our Risk Management resource for best practices.
- Test Reports from CDSCO-approved Testing Laboratories. Check the approved labs list for accredited facilities.
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process for Atherectomy Peripheral Catheters (MD15)
Importers seeking to bring Atherectomy Peripheral Catheters into India must apply for an MD15 import license. This process is managed by the central licensing authority and involves:
- Preparing comprehensive import documentation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate (if applicable), Device and Plant Master Files, and Wholesale License.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any queries raised by CDSCO.
- License grant in Form MD15.
The average processing time for import licenses is 5 to 6 months.
Timeline and Processing Duration
| License Type | Process Steps | Approximate Duration |
|---|---|---|
| Test License (MD13) | Application + Testing | 1.5 - 2 months |
| MD9 Manufacturing License | Document prep, audit, queries | 2.5 - 3 months |
| Total for MD9 | Test License + Manufacturing License | 4 - 5 months |
| MD15 Import License | Documentation + Queries + Grant | 5 - 6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | Rs. 50,000 | Rs. 1,000 per product |
| MD15 Import | Class D: Rs. 2,25,000* | Rs. 1,12,500 per product* |
*Note: Import fees are calculated in USD equivalents; consult CDSCO fee schedule for exact figures.
These fees are payable online during application submission via the CDSCO portal.
Common Challenges and Solutions
- Delayed Test Reports: Collaborate early with government-approved labs to ensure prompt testing. Use the Testing Laboratories list to select suitable labs.
- Incomplete Documentation: Use checklists and templates for Device Master File and Plant Master File to avoid gaps.
- Audit Non-Compliance: Prepare your facility with mock audits and ensure QMS adherence.
- Query Resolution Delays: Assign dedicated regulatory personnel for prompt responses to CDSCO queries.
Our practical tip: Initiate the test license application simultaneously with document preparation to optimize timelines.
Expert Consultation and Support
Navigating CDSCO’s regulatory requirements for Class D devices like the Atherectomy Peripheral Catheter demands specialized knowledge. Our team leverages 25+ years of regulatory expertise to provide:
- End-to-end license application preparation and submission
- Assistance with technical documentation and audit readiness
- Liaison with CDSCO and notified bodies
- Risk management and QMS consulting
Engaging expert consultants can significantly reduce processing times and ensure compliance, preventing costly rejections or delays.
Getting Started with Your CDSCO License Application
- Assess Classification and Requirements: Confirm your device classification as Class D and understand MD9 license prerequisites.
- Register on CDSCO MD Online Portal: Begin by creating an account on the CDSCO MD Online Portal.
- Prepare Test License Application (Form MD13): Submit this as the first step to enable product testing.
- Coordinate Product Testing: Book slots with CDSCO-approved labs early.
- Develop Comprehensive Documentation: Draft and finalize Device and Plant Master Files, Risk Management Files, and QMS documents.
- Apply for MD9 License (Form MD7): After test license and testing completion, apply for the manufacturing license.
- Prepare for Audit: Conduct internal audits and gap analysis before the CDSCO inspection.
- Respond to Queries Promptly: Maintain open communication lines with CDSCO inspectors.
By following these practical steps, manufacturers and importers can strategically approach the license application process, minimizing delays and ensuring regulatory compliance.
For additional insights, explore our detailed guides on the MD9 License process and related documentation.
Embarking on your CDSCO licensing journey with expert support and clear guidance enables timely market access for your Atherectomy Peripheral Catheter, ensuring patient safety and regulatory compliance in India’s evolving medical device landscape.
