CDSCO License for Intestinal splint

Introduction to Intestinal Splint and Its Regulatory Importance

An intestinal splint is a specialized sterile medical device, either rigid or flexible, designed to be implanted within the abdomen. Its primary function is to stabilize or protect an injured segment of the intestine. Classified under gastroenterology devices, the intestinal splint plays a critical role in post-surgical care and trauma management. Given its implantable nature and direct contact with internal tissues, the Indian regulatory framework classifies it as a Class C medical device, indicating a moderate to high risk category.

Navigating regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is essential for manufacturers and importers aiming to enter the Indian market. Compliance ensures patient safety, product efficacy, and legal market access. With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we provide a comprehensive roadmap tailored specifically for intestinal splints.

CDSCO Regulatory Framework for Intestinal Splints

The CDSCO regulates medical devices in India under the Medical Device Rules, 2017. Intestinal splints fall under the Class C category as per the Notification 29/Misc./03/2020-DC (182) dated 27.09.2021. This classification mandates adherence to stringent manufacturing and import licensing protocols, including product testing, quality management systems (QMS), and audits.

Manufacturing licenses for Class C devices are issued by the Central Licensing Authority through the MD9 license application process. Similarly, importers must obtain the MD15 license for lawful import and distribution.

For detailed classification verification, manufacturers can review the Medical Device Classification guidelines.

Risk Classification and License Requirements for Intestinal Splints

• Risk Class: C (Moderate to high risk, implantable device)
• Manufacturing License: MD9 (Application Form MD7)
• Import License: MD15 (Application Form MD14)
• Regulatory Authority: Central Licensing Authority (CDSCO)

Class C devices such as intestinal splints require rigorous compliance including product testing from government-approved laboratories, submission of comprehensive technical documentation, and facility audits.

Manufacturing License Process (MD9) for Intestinal Splints

Obtaining an MD9 license for manufacturing intestinal splints involves several sequential steps:

1. Test License (MD13) Application: Apply for a test license on Form MD13 through the CDSCO MD Online Portal. This allows initial manufacture for testing purposes.
2. Product Testing: Submit samples to CDSCO-approved laboratories for comprehensive testing. Refer to the Testing Laboratories list for authorized facilities.
3. Document Preparation: Prepare detailed technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. MD9 License Application: Submit Form MD7 along with the necessary documents.
5. Audit: CDSCO inspectors conduct on-site audits to verify compliance with Good Manufacturing Practices (GMP) and QMS.
6. Query Resolution: Address any queries raised by CDSCO during the review and audit process promptly.
7. License Grant: Upon satisfactory compliance, CDSCO issues the MD9 manufacturing license on Form MD9.

For an in-depth understanding of each step, consult our detailed MD9 License Guide.

Manufacturing License Documents Required for Intestinal Splints

The following documents are mandatory to support your MD9 license application:

• Company Constitution (Incorporation certificate, partnership deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Details of Technical Staff (Biomedical engineers, QA/QC personnel)
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (Device Master File Guide)
• Plant Master File outlining manufacturing facility details (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File documenting hazard identification and mitigation strategies (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Labeling samples and Instructions for Use (IFU)
• Quality Management System (QMS) documents, typically ISO 13485:2016 certification and SOPs

Import License Process (MD15) for Intestinal Splints

For importers intending to bring intestinal splints into India, the MD15 license process is administered by the Central Licensing Authority:

1. Document Preparation: Compile all required documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, and others.
2. License Application: Submit Form MD14 through the CDSCO MD Online Portal.
3. Review and Queries: CDSCO reviews the application and may raise clarifications or requests for additional information.
4. License Issuance: Upon satisfactory review, the MD15 import license is granted.

Our Import License Guide provides step-by-step assistance for this process.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License issued in India
• Company Constitution Documents
• Labeling and IFU

Timeline and Processing Duration

Please note timelines can vary based on documentation completeness and audit scheduling.

Government Fees and Costs

• MD9 Manufacturing License Fees:

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

• MD13 Test License Fee: Approx. INR 5,000

• MD15 Import License Fees (Class C devices):

  • Site Fee: USD 3,000
  • Per Product Fee: USD 1,500

Investing in thorough documentation and early audit readiness can minimize delays and additional costs.

Common Challenges and Solutions

Challenge: Delays in product testing due to laboratory backlogs.

Solution: Engage with CDSCO-approved labs early and consider pre-submission meetings to align on testing protocols.

Challenge: Non-compliance findings during audit.

Solution: Conduct internal pre-audits, develop corrective action plans, and maintain a robust QMS.

Challenge: Incomplete or inconsistent documentation.

Solution: Utilize expert regulatory consultants to cross-verify document packages before submission.

Challenge: Complexities in risk management documentation.

Solution: Follow best practices outlined in our Risk Management Guide to create compliant risk files.

Expert Consultation and Support

With over 25 years of experience and a track record of assisting 500+ companies, our regulatory consulting services offer:

• Tailored gap analysis for intestinal splint manufacturing/import licensing
• End-to-end documentation support including Device and Plant Master Files
• Coordination with notified bodies and CDSCO inspectors
• Pre-testing and pre-audit readiness assessments
• Timely application submission via the CDSCO MD Online Portal

We also provide insights on selecting the right notified body for audits – browse the list of notified bodies authorized by CDSCO.

Getting Started with Your CDSCO License Application for Intestinal Splint

1. Confirm Device Classification: Verify your intestinal splint under Class C using official CDSCO notifications.
2. Prepare Initial Documentation: Collect company constitution, premises ownership, QMS certificates, and draft Device and Plant Master Files.
3. Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal to legally manufacture samples for testing.
4. Coordinate Product Testing: Engage with CDSCO-approved labs early to schedule testing.
5. Compile Full Application: Upon successful testing, gather all technical and compliance documents for the MD9 application.
6. Engage Regulatory Experts: Consider partnering with experienced consultants to streamline audit readiness and query responses.
7. Submit Application and Track Progress: Use the online portal to monitor your application status and respond swiftly to any CDSCO queries.

By following these actionable steps, manufacturers and importers can confidently navigate the complex CDSCO licensing landscape for intestinal splints and successfully access the growing Indian medical device market.