CDSCO License for Scalp clip.

Introduction to Scalp Clip and Its Regulatory Importance

Scalp clips are specialized medical devices designed to control bleeding during neurological surgeries involving the scalp. Constructed typically from plastic or metal, these clips play a vital role in ensuring surgical efficacy and patient safety. Given their direct application in invasive procedures, scalp clips are classified as Class C medical devices under the CDSCO regulatory framework, indicating a moderate to high risk.

Navigating the Indian regulatory landscape for such devices requires meticulous preparation and compliance. With over 25 years of experience and having supported 500+ manufacturers and importers, we provide comprehensive guidance to streamline your CDSCO licensing journey.

CDSCO Regulatory Framework for Scalp Clips (Class C Device)

The Central Drugs Standard Control Organization (CDSCO) governs the approval, import, and manufacture of medical devices in India. Class C devices, such as scalp clips, fall under the Central Licensing Authority's jurisdiction, necessitating a more stringent review process compared to Class A and B devices.

Regulatory compliance ensures that scalp clips meet essential safety, quality, and performance standards before reaching Indian healthcare providers. The relevant notification for scalp clips is 29/Misc/03/2020-DC (201), issued on 27.09.2021.

Risk Classification and License Requirements for Scalp Clips

• Risk Class: C
• License Type: MD9 Manufacturing License (Form MD7) for domestic production
• Licensing Authority: Central Licensing Authority (CDSCO Headquarters)

Class C devices require:

• A test license (MD13) to facilitate product testing
• Product testing at CDSCO-recognized laboratories
• Comprehensive documentation including Device Master File, Plant Master File, Risk Management File
• An audit by CDSCO inspectors

For detailed device classification, refer to our Medical Device Classification guide.

Manufacturing License Process (MD9 License) for Scalp Clip

1. Test License Application (Form MD13): Submit your application through the CDSCO MD Online Portal. The test license permits product testing in notified labs and typically takes 1.5 to 2 months to be granted.

2. Product Testing: After receiving the test license, conduct mandatory testing at government-approved labs listed on the Testing Laboratories page. Testing ensures compliance with Indian standards.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents. Our Device Master File Guide and Plant Master File Guide can help streamline this step.

4. License Application (Form MD7): File your manufacturing license application for MD9 on the CDSCO MD Online Portal.

5. Audit: CDSCO inspectors conduct a thorough audit of your manufacturing facility and processes. This audit assesses compliance with Good Manufacturing Practices (GMP) and QMS.

6. Query Resolution: Address any queries raised by CDSCO or inspectors promptly to avoid delays.

7. Grant of License (Form MD9): Upon successful audit and documentation review, CDSCO issues the manufacturing license.

For a detailed walkthrough, consult our MD9 License Guide.

Manufacturing License Documents Required for Scalp Clip

• Company constitution documents (Certificate of Incorporation, Memorandum of Association)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and experience details
• Fire NOC and Pollution Control Board NOC
• Device Master File (including design specifications, materials, manufacturing process)
• Plant Master File (facility layout, equipment details, cleanliness standards)
• Essential Principles Checklist affirming compliance with standards
• Risk Management File aligned with ISO 14971 standards (Risk Management Guide)
• Test reports from CDSCO-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliance)

Import License Process (MD15 License) for Scalp Clip

For companies importing scalp clips into India, the MD15 import license issued by the Central Licensing Authority is mandatory. The process is as follows:

1. Document Preparation: Compile all necessary certificates including manufacturing license from the country of origin, Free Sale Certificates, ISO 13485:2016, CE Certificates, Device and Plant Master Files, Wholesale License, and Company Constitution.

2. Application Submission: File Form MD14 for MD15 license on the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any information requests.

4. Grant of Import License (Form MD15): Typically granted within 5-6 months.

Our Import License Guide offers detailed insights.

Import License Documents Required

• 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 license in India
• Company constitution and ownership proof

Timeline and Processing Duration

Import licenses (MD15) typically require 5-6 months.

Government Fees and Costs for Scalp Clip Licensing

• MD9 License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD13 Test License:

  • Included in overall process fees, but expect additional costs related to testing

• Import License (MD15):

  • Class C/D fee: $3,000 per site +$1,500 per product

Additional costs include laboratory testing fees, consultancy, and audit preparation.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited capacity at notified laboratories.

Solution: Plan early, select labs carefully from the official Testing Laboratories list, and consider parallel documentation work during testing.

Challenge: Incomplete or inconsistent documentation leading to audit findings.

Solution: Leverage templates and expert reviews from experienced regulatory consultants to ensure completeness.

Challenge: Query resolution delays causing extended timelines.

Solution: Maintain an organized query tracking system, and assign dedicated personnel to respond quickly.

Challenge: Understanding complex technical requirements like Risk Management and Essential Principles.

Solution: Use our comprehensive Risk Management guide and checklist tools.

Expert Consultation and Support

With over 25 years of hands-on experience and more than 500 successful CDSCO licensing projects, our team offers end-to-end support—from initial classification and documentation to audit facilitation and regulatory submissions. We help you avoid common pitfalls and accelerate your market entry.

Getting Started with Your CDSCO License Application for Scalp Clip

1. Initial Assessment: Verify your device classification and licensing requirements.

2. Register on CDSCO MD Online Portal: Create your company profile on the official portal.

3. Prepare Test License Application (MD13): Gather preliminary documents and submit the application.

4. Plan for Product Testing: Schedule testing with notified laboratories early.

5. Organize Documentation: Develop Device and Plant Master Files using our guides.

6. Consult Experts: Engage a regulatory consultant to review all submissions and help prepare for audits.

7. Submit Manufacturing License Application (MD9): Upon successful testing and document readiness.

8. Prepare for Audit and Respond to Queries: Ensure smooth audit compliance.

By following these practical steps and leveraging our expertise, you can confidently navigate the CDSCO licensing process for scalp clips and successfully bring your product to the Indian market.