CDSCO License for Thoracic suction pump

Comprehensive Guide to CDSCO Licensing for Thoracic Suction Pump (Class B Medical Device)

As seasoned regulatory consultants with over 25 years of expertise and having assisted 500+ companies, we understand the critical importance of securing timely and compliant CDSCO licenses for medical devices like the thoracic suction pump. This respiratory device, classified as Class B under the CDSCO framework, requires adherence to specific regulatory pathways to ensure safe market entry in India.

Understanding the Thoracic Suction Pump and Regulatory Importance

A thoracic suction pump is designed to generate negative pressure to aspirate fluids, secretions, and air, facilitating normal lung and mediastinum function. Given its vital role in respiratory care, the device falls under Class B risk category, necessitating rigorous regulatory compliance to assure safety and efficacy.

CDSCO Regulatory Framework for Thoracic Suction Pump

The Central Drugs Standard Control Organization (CDSCO) oversees the regulation of medical devices in India. For Class B devices like the thoracic suction pump, the applicable manufacturing license is the MD5 license, granted by State Licensing Authorities. Importers must obtain an MD15 license from the Central Licensing Authority.

The official notification governing this device is File No. 29/Misc/03/2020-DC(197), dated 6.8.2021, which classifies thoracic suction pumps under the respiratory category.

Risk Classification and License Requirements

• Risk Class: B (Low to Moderate Risk)
• Manufacturing License: MD5 License (Form MD3)
• Import License: MD15 License (Form MD14)
• Authority: State Licensing Authority for manufacturing; Central Licensing Authority for import

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

Manufacturing License Process (MD5) for Thoracic Suction Pump

The MD5 license process typically spans 3 to 4 months and involves multiple stages:

1. Test License Application (Form MD13): Obtain a test license valid for 1.5 to 2 months to legally manufacture the device for testing purposes.
2. Product Testing: Conduct testing at CDSCO-approved laboratories to validate performance and safety. See the Testing Laboratories list.
3. Document Preparation: Compile comprehensive documents, including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) evidence.
4. Application Submission: Apply for the MD5 license through the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: Undergo a mandatory audit by a notified body listed here.
6. Query Resolution: Address any queries from CDSCO or auditors promptly.
7. License Grant: Upon successful compliance, the license is issued on Form MD5.

Manufacturing License Documents Required

Manufacturers must submit the following key documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership/Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed product specifications, design, and manufacturing process (Learn more)
• Plant Master File (PMF): Facility details, equipment, and environmental controls (Learn more)
• Essential Principles Checklist (Compliance with Indian Medical Device Rules)
• Risk Management File compliant with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO-approved testing labs
• Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 preferred)

Import License Process (MD15) for Thoracic Suction Pump

Importers of thoracic suction pumps must secure an MD15 license from the Central Licensing Authority, a process generally taking 5 to 6 months. The steps include:

1. Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
2. Application Submission: Apply online via the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond to department queries diligently.
4. License Grant: Receive the import license on Form MD15.

Import License Documents Required

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

Timeline and Processing Duration

These timelines assume prompt document submission and timely resolution of queries.

Government Fees and Costs

• MD5 License:

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

• MD15 Import License:

  • Site Fee (Class B): $2,000
  • Per Product Fee (Class B): $1,000

Please budget accordingly to avoid delays due to fee-related issues.

Common Challenges and Solutions

• Incomplete Documentation: Ensure all required files such as Device Master File and Risk Management File are meticulously prepared.
• Delayed Queries Response: Assign dedicated personnel to monitor and respond swiftly to CDSCO queries.
• Testing Delays: Use CDSCO-approved labs to avoid retesting. Refer to the Testing Laboratories list.
• Audit Non-compliance: Pre-audit your facility using checklists and engage certified notified bodies from the official Notified Bodies List.

Expert Consultation and Support

Navigating the complexities of CDSCO licensing for thoracic suction pumps requires expertise. Our team offers comprehensive support:

• Pre-submission document gap analysis
• Liaison with CDSCO and notified bodies
• End-to-end application management
• Mock audits and compliance checks

Our track record of assisting over 500 companies ensures a streamlined licensing experience.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your thoracic suction pump is Class B via the Medical Device Classification resource.
2. Prepare Required Documents: Begin compiling your Device Master File, Plant Master File, and Risk Management File.
3. Apply for Test License (MD13): Submit your application through the CDSCO MD Online Portal.
4. Plan Product Testing: Schedule testing with CDSCO-approved labs.
5. Engage a Notified Body: Select an auditor from the official Notified Bodies List.
6. Submit MD5 License Application: Once test license and testing are complete, apply for the manufacturing license.
7. Maintain Constant Communication: Regularly check the portal and respond to queries promptly to avoid delays.

Embarking on this regulatory journey can be complex, but with precise planning and expert support, your thoracic suction pump can enter the Indian market swiftly and compliantly. Contact us today to leverage our 25+ years of experience and ensure your CDSCO licensing success.