CDSCO License for Closed  Wound Drainage Tube or System

CDSCO Licensing for Closed Wound Drainage Tube or System (Class B Medical Device)

Navigating the regulatory landscape for medical devices in India can be challenging, especially for specialized devices like the Closed Wound Drainage Tube or System. As a Class B device under the catheter category, this surgical drain plays a critical role in post-operative care by removing pus, blood, or other fluids from wounds, ensuring patient safety and recovery. With over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we provide a detailed, practical guide to help manufacturers and importers efficiently obtain the necessary approvals for this device.

CDSCO Regulatory Framework for Closed Wound Drainage Tubes

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. This device is notified under Notification 29/Misc/3/2017-DC (292) dated 06.06.2018, categorizing it as a Class B medical device (moderate risk). Compliance with CDSCO ensures that the device meets quality, safety, and efficacy standards required for market authorization.

Risk Classification and License Requirements

Closed Wound Drainage Tubes fall under Class B as per the CDSCO classification – devices with moderate risk, requiring a State Licensing Authority issued MD5 manufacturing license for local manufacturers. Importers must apply for the MD15 import license from the Central Licensing Authority. The classification impacts the application form, processing time, fees, and documentation.

Manufacturing License Process for Closed Wound Drainage Tubes (MD5 License)

Manufacturers producing this Class B device domestically must obtain the MD5 license issued by the State Licensing Authority. The process involves several key steps:

1. Test License (Form MD13): Initially, apply for a test license which allows product testing. This takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved government laboratories to ensure device compliance.
3. Document Preparation: Compile required documentation, including Device Master File and Plant Master File.
4. Application Submission: Apply for the manufacturing license using Form MD3 on the CDSCO MD Online Portal.
5. Audit by Notified Body: State-appointed notified bodies conduct audits verifying compliance.
6. Query Resolution: Respond promptly to any queries raised by the licensing authority or notified body.
7. License Grant: Upon successful review, the MD5 manufacturing license (Form MD5) is granted.

The entire process typically spans 3-4 months.

Manufacturing License Documents Required for Closed Wound Drainage Tubes

To ensure a smooth application, manufacturers should prepare the following documents:

• Company Constitution (e.g., Memorandum of Association)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and CVs
• Fire NOC and Pollution Control Board NOC
• Device Master File detailing design and manufacturing processes (Device Master File Guide)
• Plant Master File describing the manufacturing facility (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File outlining hazard identification and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved laboratories (Testing Laboratories)
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 compliance preferred)

Import License Process for Closed Wound Drainage Tubes (MD15 License)

Importers of Closed Wound Drainage Tubes into India must secure the MD15 import license from CDSCO’s Central Licensing Authority. Key steps include:

1. Document Preparation: Gather comprehensive documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE marking (if applicable), Device and Plant Master Files, and wholesale license.
2. Application Submission: File the application on Form MD14 through the CDSCO MD Online Portal.
3. Review and Query Resolution: Address any clarifications from CDSCO promptly.
4. License Grant: Receive the MD15 license authorizing import.

The process generally takes 5-6 months.

Import License Documents Required

Importers should prepare these key documents:

• Valid Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Quality Management System certificate
• CE Certificate or equivalent conformity assessment
• Device Master File and Plant Master File
• Wholesale Drug License valid for medical device distribution
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD15 Import License:
  • Class B devices: Approx Rs 1,50,000 per site + Rs 1,000 per product

These fees are payable via the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays in test license and product testing due to limited lab capacity.

Solution: Pre-book testing slots at authorized labs early; consider multiple labs from the CDSCO-approved Testing Laboratories list.

Challenge: Incomplete or inconsistent documentation leading to multiple queries.

Solution: Follow detailed checklists and prepare Device and Plant Master Files meticulously; our Device Master File Guide offers actionable templates.

Challenge: Audits revealing noncompliance.

Solution: Conduct pre-audit internal reviews and engage with notified bodies listed here to understand expectations.

Expert Consultation and Support

Our extensive experience enables us to navigate the complexities of CDSCO licensing efficiently. We offer:

• Customized gap analysis and documentation support
• Coordination with notified bodies and testing labs
• Timely responses to regulatory queries
• Training on compliance and risk management

Getting Started with Your CDSCO License Application

1. Classify your device accurately using the official CDSCO classification to confirm Class B status.
2. Initiate the test license application (Form MD13) via the CDSCO MD Online Portal.
3. Schedule product testing at authorized labs early to avoid delays.
4. Prepare comprehensive documentation including Device and Plant Master Files, risk management files, and quality management system evidence.
5. Engage with experienced consultants to review your application package before submission.
6. Submit your manufacturing license application (Form MD3) for MD5 license once testing is complete.
7. Prepare for the notified body audit and ensure your facility and processes meet all regulatory requirements.
8. Maintain open communication with the licensing authority to resolve queries swiftly.

By following these practical steps and leveraging expert guidance, manufacturers and importers of Closed Wound Drainage Tubes can achieve timely CDSCO licensing, ensuring compliance and a successful market entry in India.