CDSCO License for Closed-ended intestinal ostomy bag, multiple-piece

Comprehensive CDSCO Licensing Guide for Closed-ended Intestinal Ostomy Bags (Class A Medical Device)

As specialists with over 25 years of experience guiding more than 500 medical device manufacturers and importers, we understand the importance of seamless regulatory compliance for market success in India. The Closed-ended Intestinal Ostomy Bag, multiple-piece – a Class A medical device used in gastroenterology – demands a meticulous approach to obtaining the CDSCO manufacturing or import license.

Understanding the Device and Regulatory Importance

A Closed-ended Intestinal Ostomy Bag is a non-sterile plastic pouch designed to be attached around a fecal stoma, serving as a receptacle for feces post-colostomy. Classified as a Class A device under the CDSCO framework, it represents the lowest risk category but still requires strict adherence to regulatory standards to ensure patient safety and product quality.

The notification governing this device is 29/Misc./03/2020-DC (182), dated 27.09.2021, which outlines the regulatory obligations for manufacturers and importers intending to market this product in India.

CDSCO Regulatory Framework for Closed-ended Intestinal Ostomy Bags

India's Central Drugs Standard Control Organization (CDSCO) regulates medical devices according to risk classification. For Class A devices, the licensing authority is the State Licensing Authority, and the relevant manufacturing license is known as an MD5 license.

Manufacturers must secure an MD5 license to legally produce and sell the device within India. Importers, on the other hand, require an MD15 import license granted by the Central Licensing Authority.

Risk Classification and License Requirements

• Device: Closed-ended Intestinal Ostomy Bag, Multiple-piece
• Risk Class: A (Low Risk)
• Applicable License: MD5 (Manufacturing License - Form MD3)
• Licensing Authority: State Licensing Authority
• Import License: MD15 (Form MD14) from Central Licensing Authority

For a detailed understanding of medical device classification, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process for Class A Devices (MD5 License)

The MD5 license process involves several key steps:

1. Apply for Test License (MD13): Before the manufacturing license, you must obtain a test license on Form MD13. This allows sample testing of devices.
2. Testing of Device: Conduct product testing at government-approved laboratories to ensure compliance with Indian standards. A list of approved Testing Laboratories is available on the CDSCO portal.
3. Documentation Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.
4. Application Submission: Submit the manufacturing license application using Form MD3 via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit of manufacturing facilities and processes is conducted by a notified body listed on the Notified Bodies List.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License: Upon satisfactory audit and document review, the MD5 license is granted on Form MD5.

For an in-depth walkthrough, consult our MD5 License Guide.

Manufacturing License Documents Required

Specific documentation is critical to the success of your application:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design and manufacturing (see our Device Master File guide)
• Plant Master File outlining facility layout and processes (Plant Master File guide)
• Essential Principles Checklist confirming compliance with Indian medical device standards
• Risk Management File demonstrating risk assessment and mitigation (Risk Management guide)
• Product Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485:2016 compliance recommended)

Import License Process for Closed-ended Intestinal Ostomy Bags (MD15 License)

If you are importing this Class A device into India, an MD15 import license is mandatory. The central authority grants this license based on the following process:

1. Document Preparation: Compile required documents including your manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, Wholesale License, and company constitution.
2. Application Submission: Submit the application on Form MD14 through the CDSCO MD Online Portal.
3. Review and Query Resolution: The CDSCO reviews your submission and raises queries if necessary.
4. Grant of License: After satisfactory review, the import license is issued on Form MD15.

For more details on import licensing, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Incorporation Documents

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3-4 months total

  • Test License (MD13): 1.5 to 2 months
  • Testing & Documentation: 2-3 weeks
  • Notified Body Audit & Review: 3-4 weeks
  • Query Resolution & Final Approval: 2-3 weeks

• MD15 Import License: Approximately 5-6 months

These timelines may vary depending on query resolution speed and completeness of documentation.

Government Fees and Costs

For the Closed-ended Intestinal Ostomy Bag (Class A device):

• MD5 License:

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

• MD15 Import License:

  • Site Fee: USD 1,000
  • Per Product Fee: USD 50

Additional costs may include testing fees at government-approved laboratories and audit fees charged by notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face delays due to missing or inaccurate documents. We recommend using comprehensive checklists and templates, such as our Device Master File guide.

• Delays in Testing: Government labs can have backlogs. Planning and early sample submission can mitigate delays.

• Audit Non-compliance: Ensuring your facility meets GMP and QMS standards before the notified body audit is crucial. Pre-audit assessments can help.

• Query Resolution Delays: Assign dedicated regulatory personnel to respond swiftly to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing for medical devices – especially detailed processes like MD5 and MD15 licenses – requires expertise. Our seasoned consultants provide:

• End-to-end application preparation and submission
• GMP and QMS compliance advisory
• Coordination with notified bodies and testing labs
• Timely query management and follow-up

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm that your closed-ended intestinal ostomy bag is Class A.
2. Prepare Required Documentation: Gather all documents listed above meticulously.
3. Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
4. Conduct Product Testing: Send samples to approved laboratories promptly.
5. Prepare for Audit: Align your manufacturing facility with required standards.
6. Submit Manufacturing License Application (Form MD3): Apply via the CDSCO portal.
7. Engage Expert Support: Utilize experienced regulatory consultants to streamline the process.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can efficiently obtain their CDSCO licenses and enter the Indian market with confidence.

We invite you to contact us for personalized assistance tailored to your Closed-ended Intestinal Ostomy Bag licensing needs.