CDSCO License for Disposable Hemoperfusion Cartridge

Comprehensive Guide to CDSCO Licensing for Disposable Hemoperfusion Cartridge (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience assisting more than 500 companies obtain CDSCO licenses, we understand the complexities involved in bringing advanced medical devices like the Disposable Hemoperfusion Cartridge to the Indian market. This device, classified as Class C under CDSCO’s regulations, plays a critical role in nephrology and renal care by adsorbing toxins and residual drugs through extracorporeal blood circulation. Navigating the licensing requirements for such a specialized device demands precision, thorough documentation, and adherence to strict timelines.

CDSCO Regulatory Framework for Disposable Hemoperfusion Cartridge

The Central Drugs Standard Control Organization (CDSCO) governs medical device approvals in India. Since the notification dated 13.09.2021 (Notification 29/Misc./03/2020-DC (143)), hemoperfusion cartridges fall under Class C devices—defined by moderate to high risk. This classification mandates obtaining a manufacturing or import license directly from the Central Licensing Authority under the MD9 or MD15 schemes respectively.

Risk Classification and License Requirements for Class C Devices

The Disposable Hemoperfusion Cartridge is categorized under Class C due to its direct blood contact and role in toxin removal, which can significantly impact patient safety and treatment outcomes. According to CDSCO’s medical device classification, Class C devices require:

• A manufacturing license through Form MD7 (MD9 license)
• Stringent testing from government-approved labs
• Audit by CDSCO inspectors
• Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and QMS system

Manufacturing License Process for MD9 (Class C Devices)

For manufacturing the Disposable Hemoperfusion Cartridge in India, the MD9 license application process consists of several critical steps:

1. Test License Acquisition (Form MD13): Apply for a test license for about 1.5 to 2 months to legally manufacture the device samples for testing.
2. Product Testing: Complete mandatory testing at CDSCO-approved labs to validate safety and efficacy.
3. Documentation Preparation: Compile technical and quality documents, including Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.
4. Application Submission (Form MD7): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. CDSCO Audit: Undergo inspection and audit by CDSCO officials ensuring compliance with Good Manufacturing Practices (GMP).
6. Query Resolution: Address any observations or queries raised by the CDSCO or audit team promptly.
7. License Grant: Upon satisfactory inspection and document review, the MD9 license is issued.

For detailed guidance, refer to our MD9 License Guide.

Manufacturing License Documents Required for Disposable Hemoperfusion Cartridge

To streamline your application, prepare the following essential documents:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File describing manufacturing facility and quality control setups (Plant Master File Guide)
• Essential Principles Checklist ensuring compliance with Indian and international standards
• Risk Management File demonstrating identification and mitigation of device risks (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485 certification)

Import License Process for Disposable Hemoperfusion Cartridge (MD15)

If you are importing the Disposable Hemoperfusion Cartridge into India, the process involves obtaining the MD15 import license:

1. Documentation Preparation: Collect manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), and CDSCO required files.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Promptly respond to any departmental queries.
4. License Grant: The MD15 license is granted after satisfactory review.

Note that unlike MD9, no test license is required before application, but the process is longer (5-6 months).

Import License Documents Required

• Valid Manufacturing License from country of origin
• Free Sale Certificate ensuring market authorization abroad
• ISO 13485:2016 Certification
• CE Certificate or equivalent safety approvals
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution and Registration Documents

For more details, consult our Import License Guide.

Timeline and Processing Duration

Import licenses (MD15) typically take 5 to 6 months due to extensive document verification.

Government Fees and Costs

• MD9 Manufacturing License Fees:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• Test License Fee (Form MD13): ₹5,000

• Import License Fees (MD15):

  • Per Site: ₹3,00,000
  • Per Product: ₹1,50,000

Note: Fees are exclusive of testing charges and audit costs, which vary based on notified body selected.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to limited slots at government labs.

Solution: Plan and book testing early through the CDSCO list of testing laboratories. Consider parallel document preparation to optimize timelines.

Challenge: Non-compliance identified during CDSCO audits.

Solution: Engage experienced notified bodies (consult the list of notified bodies) for pre-audit assessments and conduct internal mock audits.

Challenge: Incomplete or inconsistent documentation.

Solution: Follow comprehensive checklists and templates for Device Master File and Risk Management File. Utilize expert consultants to review submissions.

Expert Consultation and Support

With our extensive track record in navigating CDSCO regulations for Class C devices like Disposable Hemoperfusion Cartridges, we offer tailored support including:

• Gap analysis and documentation review
• Assistance with test license and product testing coordination
• End-to-end application filing on the CDSCO MD Online Portal
• Audit preparation support
• Prompt handling of regulatory queries

Our proactive approach has helped clients reduce approval timelines and mitigate costly rejections.

Getting Started with Your CDSCO License Application

To initiate your CDSCO licensing journey for the Disposable Hemoperfusion Cartridge:

1. Register on the CDSCO MD Online Portal.
2. Compile your technical and quality documentation as per the MD9 requirements.
3. Apply for the Test License (Form MD13) immediately to begin manufacturing samples for testing.
4. Schedule testing at government-approved laboratories.
5. While waiting for test results, prepare your Device and Plant Master Files, Risk Management documentation, and Essential Principles checklist.
6. Once testing is complete, submit your MD9 license application (Form MD7) via the portal.
7. Prepare for the CDSCO audit by conducting internal reviews and training staff.
8. Respond promptly to any queries to avoid delays.

By following this structured roadmap, manufacturers can confidently navigate the regulatory landscape and bring their Disposable Hemoperfusion Cartridge to the Indian market efficiently and compliantly.