CDSCO License for Intestinal stoma shield/support belt, reusable

Introduction to Intestinal Stoma Shield/Support Belt and Regulatory Importance

An intestinal stoma shield or support belt is a crucial gastroenterology medical device designed to protect enteric stomas from external trauma, reduce the risk of stomal herniation, and assist in maintaining adhesion of the base plate to the skin. Typically non-sterile and reusable, this device plays a vital role in improving patient comfort and post-surgical outcomes.

Given its medical purpose and potential patient impact, regulatory compliance is mandatory before marketing or manufacturing in India. The Central Drugs Standard Control Organization (CDSCO) governs the licensing and approval of such devices to ensure safety and efficacy.

With over 25 years of experience and having supported 500+ companies in securing CDSCO approvals, we offer detailed, actionable insights specific to your intestinal stoma shield device (Risk Class A) to navigate the licensing process with confidence.

CDSCO Regulatory Framework for Intestinal Stoma Shield (Class A Medical Devices)

The intestinal stoma shield falls under Class A, the lowest risk category in the CDSCO medical device classification system. As per Notification 29/Misc./03/2020-DC (182) dated 27.09.2021, this device is regulated under the Medical Device Rules, 2017.

Class A devices require compliance primarily at the State Licensing Authority level for manufacturing licenses (MD5) and at the Central Licensing Authority for import licenses (MD15). The regulatory framework emphasizes proper documentation, testing, and quality management systems.

For detailed classification criteria, manufacturers can refer to the Medical Device Classification guide.

Risk Classification and License Requirements for Intestinal Stoma Shield

• Risk Class: A (Low risk)
• Manufacturing License: MD5 License (State Licensing Authority) via Form MD3
• Import License: MD15 License (Central Licensing Authority) via Form MD14

Class A devices like the intestinal stoma shield require a test license (MD13) before the manufacturing license application. The entire process includes product testing, audit, and document verification to ensure compliance with Indian standards.

Manufacturing License Process (MD5) for Intestinal Stoma Shield

The MD5 manufacturing license process is managed by the State Licensing Authority and typically spans 3 to 4 months. The stepwise process is:

1. Apply for Test License (Form MD13): Obtain permission to test your device samples in government-approved labs. This step takes approximately 1.5 to 2 months.

2. Product Testing: Conduct testing at CDSCO-recognized laboratories listed in the Testing Laboratories directory.

3. Document Preparation: Compile essential documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.

4. Apply for Manufacturing License (Form MD3): Submit your application on the CDSCO MD Online Portal.

5. Audit by Notified Body: An audit by a notified body ensures compliance with manufacturing practices. Refer to the list of notified bodies to select an authorized auditor.

6. Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body.

7. License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.

For a comprehensive overview, review our MD5 License Guide.

Manufacturing License Documents Required for Intestinal Stoma Shield

Prepare the following documents meticulously to avoid delays:

• Company Constitution (Memorandum and Articles of Association)
• Proof of ownership/lease of manufacturing premises
• Technical staff qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design, manufacturing, and quality aspects (Device Master File Guide)
• Plant Master File describing manufacturing site and processes (Plant Master File Guide)
• Essential Principles Checklist ensuring device compliance with Indian regulatory standards
• Risk Management File documenting risk analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU)
• Quality Management System (QMS) documents such as ISO 13485 certificates, SOPs, and validation records

Import License Process (MD15) for Intestinal Stoma Shield

Importers of intestinal stoma shields must obtain the MD15 license from the Central Licensing Authority. The process generally takes 5 to 6 months and involves:

1. Document Compilation: Prepare required documents, including a valid manufacturing license from the country of origin.

2. Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any queries from CDSCO.

4. License Grant (Form MD15): Upon approval, CDSCO issues the import license.

Importantly, a separate test license is not mandatory for import applications.

Refer to our detailed Import License Guide for stepwise assistance.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Importer’s authorization

Timeline and Processing Duration

Timely preparation of documents and prompt responses to queries can significantly expedite the process.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

• MD15 Import License:

  • Class A site fee: $1,000
  • Per Product Fee: $50

Additional costs include testing fees at government-approved labs and audit charges by notified bodies. Budgeting for these expenses upfront helps avoid surprises.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all required files like Device Master File and Risk Management File are comprehensive and updated. Utilize expert templates and guides to avoid omissions.

• Delayed Testing: Engage accredited labs early, and submit samples promptly. Verify lab capacity and turnaround time beforehand.

• Audit Non-Compliance: Prepare your manufacturing site as per notified body expectations. Conduct internal audits to preempt findings.

• Query Handling Delays: Designate a regulatory liaison to respond swiftly to CDSCO queries.

• Misclassification Risks: Confirm device classification with regulatory experts to apply for the correct license type.

Expert Consultation and Support

Navigating CDSCO’s regulatory landscape can be complex. Our seasoned consultants, with over 25 years and 500+ successful licensing projects, offer:

• End-to-end application preparation and submission
• Document drafting and review services
• Coordination with testing labs and notified bodies
• Training on regulatory compliance for your team

Partnering with experts ensures compliance, reduces approval time, and mitigates risks.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your intestinal stoma shield as Class A using the Medical Device Classification tool.

2. Prepare Preliminary Documents: Gather company, technical, and manufacturing site documents.

3. Apply for Test License (MD13): File your test license application via the CDSCO MD Online Portal.

4. Coordinate Product Testing: Send samples to CDSCO-approved testing laboratories (Testing Laboratories list).

5. Compile Device and Plant Master Files: Utilize our guides to develop compliant master files.

6. Engage Notified Body for Audit: Choose an auditor from the Notified Bodies list early to schedule audits.

7. Submit Manufacturing License Application (Form MD3): Once testing and audit are complete, apply online.

8. Monitor Application Progress: Keep track of queries and respond promptly.

By following these precise steps and leveraging expert support, manufacturers and importers of intestinal stoma shields can efficiently secure CDSCO licensing and bring their life-enhancing devices to the Indian market safely and compliantly.