CDSCO License for Balloon for Cerebrovascular Occlusion

Comprehensive CDSCO Licensing Guide for Balloon Catheters Used in Cerebrovascular Occlusion

The Balloon for Cerebrovascular Occlusion is a critical Class D medical device designed to treat blockages or occlusions in cerebrovascular vessels and carotid arteries. Falling under the catheter category, this device demands the highest level of regulatory scrutiny due to its invasive nature and high risk. For manufacturers and importers aiming to enter the Indian market, obtaining the appropriate CDSCO license is mandatory to ensure compliance with safety, efficacy, and quality standards.

At our consultancy, with over 25 years of experience and having successfully guided over 500 companies, we provide in-depth support to navigate the complexities of CDSCO licensing for such high-risk devices.

CDSCO Regulatory Framework for Balloon Catheters in Cerebrovascular Applications

The regulatory oversight for this device is governed by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health and Family Welfare, India. The device falls under Risk Class D as per the Medical Device Rules (MDR) 2017, notified under reference number 29/Misc/3/2017-DC (292) dated 06.06.2018.

Given the high risk associated with cerebral vessel occlusion balloons, the regulatory framework requires strict adherence to manufacturing and import controls, including rigorous testing, documentation, and audits.

Manufacturers require an MD9 Manufacturing License issued by the Central Licensing Authority, while importers must obtain an MD15 Import License.

For more on device classifications and regulatory obligations, see our Medical Device Classification guide.

Risk Classification and License Requirements for Class D Balloon Catheters

• Risk Class: D (High Risk)
• Regulatory Authority: Central Licensing Authority (CDSCO Headquarters)
• Manufacturing License: MD9 (Form MD7)
• Import License: MD15 (Form MD14)

Class D devices undergo the most stringent regulation, requiring extensive technical documentation, testing, and audits by CDSCO inspectors.

MD9 Manufacturing License Process for Balloon Catheters

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 license, manufacturers must secure a Test License on Form MD13, valid for 6 months. This allows production of samples for testing in government-approved laboratories.

• Timeline: Approximately 1.5 to 2 months

Step 2: Product Testing

Testing must be conducted at CDSCO notified laboratories to verify compliance with Indian standards. Access the List of Testing Laboratories to identify accredited facilities.

• Typical tests include biocompatibility, sterilization validation, mechanical performance, and labeling compliance.

Step 3: Document Preparation

Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and QMS documents aligned with ISO 13485:2016.

Step 4: Application Submission (Form MD7)

Apply for the MD9 license via the CDSCO MD Online Portal, attaching all required documents.

Step 5: CDSCO Audit

CDSCO officials conduct an on-site audit of manufacturing facilities and quality systems.

Step 6: Query Resolution

Address any queries or deficiencies raised by CDSCO during the review and audit.

Step 7: License Grant

Upon satisfactory completion, the MD9 license (Form MD9) is issued.

For detailed guidance, refer to our MD9 License Guide.

Documents Required for MD9 Manufacturing License

1. Company Constitution and Incorporation Certificates
2. Proof of Ownership or Lease of Manufacturing Premises
3. Technical Staff Qualification and Experience
4. Fire NOC and Pollution Control Clearance
5. Device Master File (DMF) – Refer to our Device Master File Guide
6. Plant Master File (PMF) – See our Plant Master File Guide
7. Essential Principles Checklist
8. Risk Management File – Aligned with ISO 14971, see our Risk Management resource
9. Product Test Reports from CDSCO-approved labs
10. Labeling and Instructions for Use (IFU)
11. Quality Management System Documentation (ISO 13485:2016 compliance)

Thorough preparation of these documents significantly reduces processing delays.

MD15 Import License Process for Balloon Catheters

Step 1: Document Compilation

Gather all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE Certificate, and technical files.

Step 2: Application Submission (Form MD14)

Submit your import license application via the CDSCO MD Online Portal.

Step 3: CDSCO Review and Queries

CDSCO reviews submissions and may raise queries requiring prompt responses.

Step 4: License Issuance

Once cleared, the MD15 Import License is granted allowing import and marketing.

For a comprehensive overview, see our Import License Guide.

Documents Required for MD15 Import License

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and Incorporation Documents
• Quality Management System Documentation

Timeline and Processing Duration

Note: Delays often occur due to incomplete documentation or slow query responses. Early preparation is key.

Government Fees and Costs

Additional costs include testing fees at government labs, audit fees if any, and consultancy if engaged.

Common Challenges and Practical Solutions

• Challenge: Delays in obtaining test license due to incomplete forms.

  • Solution: Use expert checklists and double-check all fields before submission.

• Challenge: Non-compliance in audit due to inadequate QMS documentation.

  • Solution: Implement ISO 13485:2016 thoroughly and conduct mock audits.

• Challenge: Extended query resolution times.

  • Solution: Assign dedicated regulatory personnel for prompt and precise responses.

• Challenge: Difficulty in product testing due to limited slots in notified labs.

  • Solution: Plan testing schedules well ahead and consider alternative CDSCO-approved labs from the Testing Laboratories list.

Expert Consultation and Support

Our seasoned regulatory consultants specialize in high-risk medical devices like cerebrovascular balloons. We assist with:

• Preparing and reviewing technical files and master files
• Coordinating with notified bodies and laboratories
• Managing audit preparations and follow-ups
• Facilitating fast-track query resolution
• End-to-end license application filing via the CDSCO MD Online Portal

Our proven methodology has helped over 500 companies successfully launch their devices in India.

Getting Started with Your CDSCO License Application

1. Assess your device classification: Confirm your balloon catheter falls under Class D using our Medical Device Classification resource.

2. Prepare your QMS and technical documentation: Begin compiling your Device and Plant Master Files.

3. Apply for Test License (MD13): Submit your initial application via the CDSCO portal.

4. Schedule product testing: Coordinate with approved laboratories early.

5. Plan for audit: Select a notified body for manufacturing audits (for MD9), see the Notified Bodies list.

6. Submit your final license application: Ensure all documents and test reports are complete before submitting Form MD7 for MD9 or MD14 for MD15.

7. Engage expert consultants: Leverage experience to avoid common pitfalls and accelerate approval.

Taking these actionable steps will ensure a smooth regulatory journey for your Balloon for Cerebrovascular Occlusion device in India.

For personalized assistance and comprehensive support, contact our expert team today.