CDSCO License for Closed Suction System

Comprehensive Guide to CDSCO Licensing for Closed Suction System (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in successfully securing CDSCO licenses, we understand the critical importance of compliance for medical devices like the Closed Suction System. This device, classified as Class B under Indian regulations, plays an essential role in patient airway management by enabling safe endotracheal suctioning. Navigating the Central Drugs Standard Control Organisation (CDSCO) licensing process can be complex, but our detailed guide will make it straightforward and actionable for manufacturers and importers aiming to enter the Indian market.

CDSCO Regulatory Framework for Closed Suction System

The Closed Suction System falls under the category of Catheters and is regulated as a Class B medical device per the notification 29/Misc/3/2017-DC (292) dated 06.06.2018. Class B devices require a manufacturing license known as MD5 License, governed by the State Licensing Authority. This licensing ensures that the device meets stringent safety, quality, and performance standards before it reaches patients.

Risk Classification and License Requirements

Under the CDSCO classification:

• Class B devices carry a moderate risk profile.
• The Closed Suction System, being a catheter used in airway management, fits squarely here.
• For manufacturing, you need an MD5 license (Form MD3 application).
• Importers require an MD15 import license (Form MD14 application) issued by the Central Licensing Authority.

For a deeper understanding of device classification and how it impacts licensing, we recommend reviewing the Medical Device Classification guide.

Manufacturing License Process (MD5) for Closed Suction System

The MD5 licensing process is multi-staged and typically spans 3 to 4 months. Here is a practical breakdown:

1. Test License (Form MD13): Initially, you must obtain a test license, which takes approximately 1.5 to 2 months. This license allows you to produce limited quantities for testing purposes.
2. Product Testing: The device must be tested at CDSCO-approved laboratories to verify compliance with applicable standards. Check the list of approved testing laboratories.
3. Documentation Preparation: Simultaneously, prepare all required documents including Device Master File (DMF), Plant Master File (PMF), and Quality Management System (QMS) documents.
4. Application Submission (Form MD3): Submit the complete application through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body from the official list to verify compliance with Good Manufacturing Practices (GMP).
6. Queries Resolution: Address any queries raised by the CDSCO or notified body.
7. Grant of License (Form MD5): Upon successful completion, the manufacturing license is granted.

For comprehensive step-by-step guidance, our MD5 License Guide is an invaluable resource.

Manufacturing License Documents Required

Your MD5 application must include:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Details of technical staff qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and specifications (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facilities and processes (Plant Master File Guide)
• Essential Principles Checklist
• Risk Management File complying with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (e.g., ISO 13485:2016 certification)

Import License Process (MD15) for Closed Suction System

For importers, the MD15 license application is submitted to the Central Licensing Authority and typically takes 5 to 6 months. The process includes:

• Preparing detailed documentation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
• Submit application on the CDSCO MD Online Portal.
• Respond promptly to any queries.
• Once cleared, the MD15 import license is issued.

Our detailed Import License Guide outlines all nuances for smooth import licensing.

Import License Documents Required

Key documents include:

• Valid manufacturing license from the foreign manufacturer
• Free Sale Certificate or equivalent
• ISO 13485:2016 certification
• CE Mark or equivalent
• Device Master File and Plant Master File
• Wholesale drug license (if applicable)
• Company Constitution and address proof

Timeline and Processing Duration

For import, expect 5 to 6 months due to additional document vetting.

Government Fees and Costs

For the Closed Suction System (Class B), the fees are as follows:

• MD5 License: Rs 5,000 per application + Rs 500 per product
• Test License (MD13): Included in above process
• MD15 Import License: Approximately $2,000 per site +$1,000 per product

These fees are payable via the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delayed Test Reports: Testing labs often have backlogs; plan testing early and choose labs wisely from the approved list.
• Incomplete Documentation: Ensure all files like DMF, PMF, risk management, and QMS are complete and compliant.
• Audit Non-Compliance: Pre-audit internal checks and readiness can avoid surprises during notified body inspections.
• Query Delays: Assign a dedicated team member to respond swiftly to CDSCO queries.

Expert Consultation and Support

Leveraging expert consultants can drastically reduce the risk of rejection or delays. With our experience advising 500+ companies, we offer:

• Tailored document preparation support
• Audit readiness training
• Liaison with CDSCO officials
• End-to-end application submission and follow-up

Getting Started with Your CDSCO License Application

1. Assess your device classification to confirm Class B status.
2. Register on the CDSCO MD Online Portal and familiarize yourself with the application workflow.
3. Prepare your Device and Plant Master Files following best practices.
4. Apply for the Test License (MD13) to initiate production for testing.
5. Select a CDSCO-approved testing laboratory early to schedule timely testing.
6. Compile all required documentation concurrently during testing.
7. Submit the MD5 application (Form MD3) once test reports are in.
8. Prepare for the notified body audit by reviewing your QMS and facility.

Embarking on this process with a clear roadmap and expert support can save months of time and ensure compliance. To begin your application journey, visit the CDSCO MD Online Portal today.

For personalized assistance or to discuss your Closed Suction System licensing needs, contact our regulatory experts who have guided hundreds of companies through India’s CDSCO processes successfully.