CDSCO License for Implanted intracerebral/sub cortical stimulator for pain relief.

Comprehensive Guide to CDSCO Licensing for Implanted Intracerebral/Subcortical Stimulators for Pain Relief (Class D Neurological Devices)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 medical device manufacturers and importers, we understand the complexities involved in securing CDSCO licenses for advanced neurological devices such as implanted intracerebral/subcortical stimulators for pain relief. These Class D devices, classified under the highest risk category due to their invasive nature and critical application, require rigorous compliance with CDSCO regulations to ensure patient safety and regulatory approval.

Understanding the Implanted Intracerebral/Subcortical Stimulator Device and Regulatory Importance

An implanted intracerebral/subcortical stimulator for pain relief is a sophisticated medical device designed to deliver electrical stimulation directly to subsurface brain regions to alleviate severe, intractable pain. Given its implantable nature and direct interaction with the central nervous system, the device falls under the Class D risk category as per CDSCO’s medical device classification.

This device comprises two main components:

• Implanted Receiver with Electrodes: Surgically placed within the patient’s brain.
• External Transmitter: Sends electrical pulses transcutaneously to the implanted receiver.

Due to its critical function and potential risks, regulatory oversight is stringent. Obtaining the correct manufacturing or import license from the Central Licensing Authority (CDSCO) is mandatory before marketing in India.

CDSCO Regulatory Framework for Implanted Neurological Devices (Class D)

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules, 2017. Implanted intracerebral stimulators for pain relief fall under Class D, the highest risk category, requiring a MD9 Manufacturing License if manufactured domestically or an MD15 Import License if imported into India.

These licenses are granted by the Central Licensing Authority, reflecting the device’s complexity and risk profile. The regulatory journey involves multiple stages, including test licensing, product testing, audit inspections, and thorough document evaluations.

Risk Classification and License Requirements for This Device

• Risk Class: D (Highest risk, implantable neurological device with critical application)
• Applicable License:
  • Manufacturing: MD9 License (Form MD7)
  • Import: MD15 License (Form MD14)
• Regulatory Notifications: 29/Misc/03/2020-DC (201), notified on 27.09.2021

Manufacturing License Process (MD9) for Implanted Intracerebral Stimulators

For manufacturers aiming to produce this Class D device in India, the MD9 license process is comprehensive and spans approximately 4-5 months. The key steps include:

1. Test License Application (Form MD13): Initiate with a test license application allowing product testing, usually taking 1.5-2 months.
2. Product Testing: Mandatory testing at CDSCO-approved government laboratories to confirm safety and performance.
3. Document Preparation: Compile exhaustive technical documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
4. Submission of MD9 Application (Form MD7): Apply through the CDSCO MD Online Portal for the manufacturing license.
5. Audit Inspection: CDSCO inspectors conduct thorough audits of the manufacturing facility and quality systems, focusing heavily on compliance with ISO 13485:2016 and risk management.
6. Resolution of Queries: Address any observations or queries raised by CDSCO inspectors during the audit.
7. Grant of MD9 License: Upon satisfactory review, CDSCO grants the manufacturing license on Form MD9.

For detailed guidance on the MD9 license, consult our expert MD9 License Guide.

Manufacturing License Documents Required for Class D Devices

Manufacturers must prepare the following critical documents to ensure successful licensing:

• Company Constitution Documents: Incorporation certificates, partnership deeds, or trust deeds.
• Proof of Ownership or Lease of Manufacturing Premises: Legal documents validating the manufacturing location.
• Technical Staff Qualification and Experience Certificates: Qualified professionals must be documented.
• Fire NOC and Pollution Control Clearance: Compliance with environmental and safety regulations.
• Device Master File (DMF): Comprehensive design, manufacturing, and safety data. Refer to our Device Master File Guide.
• Plant Master File (PMF): Details of facility infrastructure and quality system processes. Explore our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with Indian essential principles.
• Risk Management File: Documentation evidencing implementation of risk management per ISO 14971. Learn more in our Risk Management Guide.
• Test Reports: Results from government-approved testing laboratories. See the list of Testing Laboratories.
• Labels and Instructions for Use (IFU): Legally compliant labeling and user manuals.
• Quality Management System (QMS) Documents: Procedures, manuals, and records compliant with ISO 13485:2016.

Import License Process (MD15) for Implanted Intracerebral Stimulators

For importers, the MD15 license process is managed by the Central Licensing Authority and typically takes 5-6 months from application to grant. The process includes:

1. Document Preparation: Assemble all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificate, DMF, PMF, and wholesale license.
2. Application Submission: Submit Form MD14 for the import license via the CDSCO MD Online Portal.
3. Evaluation and Queries: CDSCO reviews the application and may raise queries or seek clarifications.
4. License Grant: On satisfactory compliance, the MD15 license is granted for importing the device.

For detailed procedures, see our Import License Guide.

Import License Documents Required for Class D Devices

Essential documents for import licensing include:

• Valid Manufacturing License from the country of origin.
• Free Sale Certificate or Certificate of Export.
• ISO 13485:2016 Certification.
• CE Certificate or equivalent regulatory approval.
• Device Master File (DMF).
• Plant Master File (PMF).
• Wholesale drug license for distribution in India.
• Company Constitution Documents.

Timeline and Processing Duration

Proactive preparation and early submission of complete documentation can significantly reduce processing times.

Government Fees and Costs

• MD9 Manufacturing License:

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

• MD15 Import License:

  • Class D Device Import Fee per site: USD 3,000 (~INR 2.4 lakhs approx)
  • Per Product Fee: USD 1,500 (~INR 1.2 lakhs approx)

Note: Fees are payable online through the CDSCO portal during application submission.

Common Challenges and Solutions

Challenge 1: Delays Due to Incomplete Documentation

• Solution: Use comprehensive checklists and consult specialized regulatory experts to ensure all files, especially DMF and PMF, are complete and compliant.

Challenge 2: Product Testing Failures or Delays

• Solution: Select CDSCO-recognized testing laboratories early, understand test requirements, and pre-validate products internally.

Challenge 3: Audit Non-Compliance

• Solution: Implement robust QMS systems aligned with ISO 13485 and conduct mock audits using the list of notified bodies before official inspections.

Challenge 4: Regulatory Query Resolution Delays

• Solution: Assign dedicated regulatory personnel to respond promptly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing for high-risk neurological implantable devices demands expert guidance. Our team offers:

• Regulatory strategy formulation tailored for Class D devices.
• Detailed documentation preparation and review.
• Coordination with notified bodies and CDSCO inspectors.
• End-to-end application management including audit support.

Our proven track record with 500+ successful clients ensures your licensing journey is smooth, timely, and compliant.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class D status using the Medical Device Classification resource.
2. Compile Required Documents: Begin assembling your DMF, PMF, risk management files, and quality system documents.
3. Apply for Test License (for Manufacturing): Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.
4. Engage with a CDSCO-Recognized Testing Laboratory: Schedule and conduct product testing early to avoid delays.
5. Prepare for Audit: Coordinate with a notified body or CDSCO inspectors for facility audits.
6. Submit MD9 or MD15 Application: Depending on your business model, submit the appropriate application with complete documentation.
7. Respond Promptly to Queries: Maintain a dedicated regulatory team to manage follow-up communications.

By following these steps and leveraging expert support, manufacturers and importers of implanted intracerebral/subcortical stimulators for pain relief can successfully navigate the CDSCO licensing process and gain timely market access in India.

For more personalized assistance, reach out to our regulatory consultancy team to start your application journey today.