CDSCO License for Implantable ligating clip

Comprehensive Guide to CDSCO Licensing for Implantable Ligating Clips (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience assisting 500+ manufacturers and importers, we understand the critical importance of obtaining the correct CDSCO licenses to market implantable ligating clips in India. This device, classified as a Class C medical device under the CDSCO framework, plays an essential role in dermatological and plastic surgery by connecting internal tissues to aid healing. Given its implantable and non-absorbable nature, rigorous regulatory compliance is mandatory to ensure patient safety and market access.

Understanding the CDSCO Regulatory Framework for Implantable Ligating Clips

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Implantable ligating clips fall under Class C, requiring central licensing authority approvals due to their medium-to-high risk profile. The regulatory framework mandates adherence to Quality Management Systems (QMS) as per ISO 13485:2016 and compliance with Indian Medical Device Rules (IMDR) 2017.

Risk Classification and License Requirements for Implantable Ligating Clips

• Device Risk Class: Class C (Moderate to High Risk)
• License Type: Manufacturing License (MD9) and Import License (MD15)
• Regulatory Authority: Central Licensing Authority (CDSCO HQ)

Class C devices require a more stringent review process compared to Class A and B, involving detailed product testing, documentation, and audits conducted by CDSCO inspectors.

Manufacturing License Process for Implantable Ligating Clips (MD9)

Obtaining the MD9 manufacturing license involves the following key steps:

1. Test License (Form MD13): Initially, apply for a test license which is valid for 3 to 6 months. This step takes approximately 1.5 to 2 months and allows you to manufacture a limited quantity for testing purposes.

2. Product Testing: Conduct product testing at government-approved laboratories. Testing ensures adherence to Indian standards and international benchmarks. Refer to the list of notified testing laboratories for authorized labs.

3. Preparation of Documentation: Compile comprehensive technical documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System documents.

4. Application Submission: File the manufacturing license application using Form MD7 on the CDSCO MD Online Portal.

5. Inspection and Audit: CDSCO inspectors will conduct an on-site audit to verify compliance with manufacturing practices and QMS requirements.

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

7. Grant of License: Upon satisfactory review, CDSCO grants the MD9 manufacturing license on Form MD9.

For detailed guidance, our MD9 License Guide elaborates on each step.

Manufacturing License Documents Required

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Documents
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) — detailed design, manufacturing process, and safety data
• Plant Master File (PMF) — manufacturing environment, equipment, and processes
• Essential Principles Checklist as per IMDR
• Risk Management File demonstrating hazard identification and mitigation
• Product Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 compliance evidence)

Our comprehensive Device Master File guide and Plant Master File guide can assist in preparing these critical documents.

Import License Process for Implantable Ligating Clips (MD15)

Manufacturers or importers intending to bring implantable ligating clips into India must secure the MD15 import license, issued by the CDSCO central authority. The process typically spans 5 to 6 months and includes:

1. Document Preparation: Ensure all required documents are accurate and complete.

2. Application Submission: Submit the application on Form MD14 through the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any CDSCO inquiries.

4. License Grant: Upon successful evaluation, the MD15 import license is issued on Form MD15.

Import License Documents Required

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate issued by the competent authority in the exporting country
• ISO 13485:2016 Certification for the manufacturing facility
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale Drug License (for distributors)
• Company Constitution

Comprehensive insight into this process is available in our Import License Guide.

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License: Rs 50,000 per application + Rs 1,000 per product
• MD13 Test License: Included within MD9 process (no separate fee)
• MD15 Import License:
  • Class C & D Devices: $3,000 per site +$1,500 per product

Be mindful that additional costs for product testing, document preparation, and notified body audits will also apply.

Common Challenges and Practical Solutions

• Challenge: Delays in product testing due to limited slots at government-approved labs.

  • Solution: Pre-book testing schedules early; consider multiple labs to avoid bottlenecks.

• Challenge: Incomplete or inconsistent documentation causing audit queries.

  • Solution: Use checklists and templates from trusted sources; conduct internal audits prior to submission.

• Challenge: Understanding regulatory updates and notification changes.

  • Solution: Regularly monitor CDSCO notifications and updates, including the official notification 29/Misc./03/2020-DC (147) dated 26.7.2021.

• Challenge: Managing timelines and coordination between multiple stakeholders.

  • Solution: Employ a dedicated regulatory project manager and use digital tracking tools.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for implantable ligating clips demands expertise and precision. Our team specializes in end-to-end regulatory support—from documentation preparation, product testing coordination, to audit management and license submission. We also offer tailored training sessions to empower your in-house teams.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your implantable ligating clip is Class C under the Medical Devices Rules. Use this Medical Device Classification tool for verification.

2. Initiate Test License Application: Submit Form MD13 for the test license through the CDSCO MD Online Portal.

3. Engage Approved Testing Labs: Coordinate product testing early; check the list of approved labs.

4. Prepare Device and Plant Master Files: Develop detailed DMF and PMF documents using our expert guides.

5. Compile Complete Documentation: Ensure all certificates, risk files, and QMS documents are in order.

6. Submit Manufacturing License Application: Apply through Form MD7 on the CDSCO portal.

7. Prepare for Audit: Engage experienced notified bodies or CDSCO inspectors for the audit phase.

8. Plan Import License Application: Once manufacturing license is secured, prepare for the MD15 import license application.

We invite you to leverage our extensive experience and proven methodologies to streamline your CDSCO licensing journey, ensuring timely market entry with full regulatory compliance.

For personalized assistance, please contact us or visit our detailed guides linked above.