CDSCO License for Connecting Tube

Comprehensive Guide to CDSCO Licensing for Connecting Tube (Class B Catheter)

As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in successfully obtaining CDSCO licenses, we understand the nuances involved in bringing a medical device like the Connecting Tube—a Class B catheter used to provide connection to a drainage bag—into the Indian market. Navigating India's regulatory landscape can be complex, but with the right insights and preparation, manufacturers and importers can streamline the process efficiently.

Understanding the CDSCO Regulatory Framework for Connecting Tubes

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. The Connecting Tube is notified under the category "Catheters" with the notification number 29/Misc/3/2017-DC (292) dated 06.06.2018. This device is classified as a Class B medical device per the Indian medical device classification guidelines, which means it carries a low to moderate risk.

Manufacturers aiming to produce Connecting Tubes in India must obtain a manufacturing license known as the MD5 license, issued by the State Licensing Authority. Importers must secure an import license (MD15) from CDSCO's Central Licensing Authority.

Risk Classification and License Requirements for Connecting Tube

Class B devices like Connecting Tubes require an MD5 manufacturing license under Form MD3. This involves a rigorous but well-structured process including test license acquisition, product testing, document submission, and audit by a notified body.

For importers, the MD15 license is mandatory, granted by CDSCO central authorities after comprehensive document review.

Refer to Medical Device Classification for detailed classification criteria.

The Manufacturing License Process for Connecting Tube (MD5 License)

The MD5 license process for Class B Connecting Tubes involves the following steps:

1. Apply for Test License (Form MD13): Before full-scale manufacturing, you must obtain a test license which allows product testing. This typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing at CDSCO-approved labs. You can find the list of authorized Testing Laboratories on the CDSCO portal.

3. Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Submit Application for MD5 License (Form MD3): File your application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body audits your manufacturing facility to verify compliance. Refer to the list of notified bodies for eligible auditors.

6. Query Resolution: Address any observations or queries from CDSCO or the notified body promptly.

7. Grant of MD5 License: Upon satisfactory compliance, the State Licensing Authority issues the MD5 manufacturing license.

For a detailed walkthrough, see our MD5 License Guide.

Manufacturing License Documents Required for Connecting Tube

To ensure your application is robust, prepare the following key documents:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Technical Staff (Qualification and Experience Certificates)
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design and manufacturing information. Learn how to create a compliant DMF here.
• Plant Master File (PMF): Details of manufacturing facilities and processes. Our Plant Master File Guide can assist you.
• Essential Principles Checklist ensuring compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation per Risk Management guidelines
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 implementation evidence)

Import License Process for Connecting Tube (MD15 License)

If you are importing Connecting Tubes into India, the import license process differs:

1. Document Preparation: Compile all necessary documents including 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: File Form MD14 on the CDSCO MD Online Portal.

3. Query Resolution: Respond to any CDSCO queries during review.

4. Grant of MD15 License: CDSCO issues the import license after successful evaluation.

This process typically takes 5 to 6 months. For detailed guidance, see our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution within India
• Company Constitution and GST Registration

Timeline and Processing Duration

Import licenses (MD15) generally take 5 to 6 months due to the centralized review process.

Government Fees and Costs

For the MD5 manufacturing license (Class B device like Connecting Tube):

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

Additional costs include testing fees at government-approved labs (variable based on the test scope) and notified body audit fees (usually INR 50,000 to 1,00,000 depending on the auditor).

Import license fees vary by device class and number of products. For Class B devices:

• Site Fee: $2,000
• Per Product Fee: $1,000

All fees are payable through the online portal.

Common Challenges and Practical Solutions

• Incomplete Documentation: Many applicants face delays due to missing or incomplete files. We recommend cross-checking document checklists and using expert templates to ensure completeness.

• Testing Delays: Testing at CDSCO-approved labs can be bottlenecked. Plan testing well in advance and select labs with the shortest turnaround times.

• Audit Non-Compliance: Facilities often fall short on QMS implementation during audits. Conduct internal pre-audits and staff training to ensure readiness.

• Query Management: Delays in resolving CDSCO queries prolong timelines. Maintain a dedicated regulatory liaison to respond promptly.

Expert Consultation and Support

Navigating the CDSCO regulatory framework demands expertise. Our consultancy has empowered over 500 manufacturers and importers with tailored solutions—from documentation to audit preparation and post-approval compliance. We provide:

• Personalized licensing strategy and timelines
• Document drafting and review services
• Coordination with notified bodies and testing labs
• Training for technical and quality teams

Getting Started with Your CDSCO License Application for Connecting Tube

1. Assess Your Regulatory Pathway: Confirm your device class and applicable license type.

2. Register on the CDSCO MD Online Portal: This is mandatory for all applications.

3. Prepare Your Test License Application (MD13): Initiate early to avoid delays.

4. Engage a Notified Body: Identify and contact an authorized notified body for your audit.

5. Compile Documentation: Use checklists and templates to prepare your Device Master File, Plant Master File, and QMS documents.

6. Schedule Product Testing: Book slots at CDSCO-approved labs promptly.

7. Submit Your MD5 License Application (Form MD3): After successful testing, apply online.

8. Prepare for Audit: Conduct internal audits and train your team.

9. Respond to Queries: Address any CDSCO or notified body concerns quickly.

10. Obtain License and Commence Manufacturing: Once granted, comply with ongoing post-market surveillance.

Our experienced team is ready to assist you through each step. Contact us to kick-start your CDSCO licensing journey for your Connecting Tube device and gain timely access to India's growing medical device market.