CDSCO License for Implantable pulse generator mesh bag,  bioabsorbable

Comprehensive Guide to CDSCO License for Implantable Pulse Generator Mesh Bag (Bioabsorbable) – Class D Neurological Device

Introduction: Implantable Pulse Generator Mesh Bag and Regulatory Importance

The implantable pulse generator (IPG) mesh bag, bioabsorbable, is a cutting-edge Class D neurological medical device designed to envelop implantable pulse generators such as cardiac pacemakers, defibrillators, and neurostimulators. Its primary function is to stabilize the implant within the subcutaneous pocket, ensuring device security and patient safety. Given its implantable nature and critical neurological application, this device falls under the highest risk classification – Class D – mandating strict regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) in India.

Navigating the CDSCO regulatory framework for such a high-risk device requires specialized knowledge and meticulous preparation. With over 25 years of experience and having supported more than 500 companies, we understand the nuances of successfully obtaining the necessary approvals to launch this device in the Indian market.

CDSCO Regulatory Framework for Implantable Pulse Generator Mesh Bag

The regulation of implantable devices like the bioabsorbable IPG mesh bag is governed by the Medical Device Rules (MDR) 2017 and subsequent amendments. The CDSCO acts as the Central Licensing Authority for Class C and D devices, overseeing manufacturing, import, testing, and audit processes.

For Class D devices, the manufacturing license is issued under Form MD9, and import licenses under Form MD15. The regulatory pathway is rigorous, reflecting the device’s potential impact on patient health and safety.

Risk Classification and License Requirements for Class D Devices

Our device is classified as Class D due to its implantable nature and critical neurological use, indicating the highest risk category. This classification means:

• Central Licensing Authority approval is mandatory.
• Manufacturing license requires an MD9 license (Form MD7 application).
• Import license requires an MD15 license (Form MD14 application).
• Stringent product testing, quality management systems, and audit by CDSCO inspectors are compulsory.

To confirm device classification and regulatory requirements, manufacturers can refer to the detailed Medical Device Classification guide.

Manufacturing License Process (MD9) for Class D Devices

The manufacturing license process for Class D devices like the bioabsorbable IPG mesh bag is comprehensive and typically spans 4 to 5 months. The process includes:

1. Test License Application (Form MD13): The manufacturer first applies for a test license to produce samples for mandatory testing. This step usually takes 1.5 to 2 months.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories. The list of approved Testing Laboratories can be consulted to select an appropriate facility.
3. Documentation Preparation: Preparation of essential documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documentation.
4. Application for Manufacturing License (Form MD7): Submission via the CDSCO MD Online Portal for the MD9 license.
5. Audit by CDSCO Inspectors: On-site audit to verify compliance with MDR 2017, GMP, and QMS.
6. Queries and Clarifications: Resolution of any queries raised by CDSCO.
7. Grant of Manufacturing License (Form MD9): Upon satisfactory compliance, the license is granted.

For detailed guidance on this process, refer to our MD9 License Guide.

Manufacturing License Documents Required for MD9

For the Class D implantable pulse generator mesh bag, manufacturers must submit the following documents:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Personnel
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Details of device design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (PMF): Details of manufacturing facility and processes (Plant Master File Guide)
• Risk Management File: Demonstrating adherence to ISO 14971 and risk mitigation (Risk Management)
• Essential Principles Checklist: Compliance with Indian MDR essential principles
• Test Reports: From government-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System Documents: ISO 13485:2016 certification and SOPs

Import License Process (MD15) for Class D Devices

For importers of the implantable pulse generator mesh bag, the MD15 import license is mandatory. The process typically takes 5 to 6 months and involves:

1. Document Preparation: Including manufacturing license, ISO certification, Free Sale Certificate, CE certificate, device and plant master files.
2. Application Submission: Using Form MD14 through the CDSCO MD Online Portal.
3. Review and Queries: CDSCO reviews documents and may raise questions.
4. Grant of Import License: Upon satisfactory review, the MD15 license is issued.

Refer to our detailed Import License Guide for step-by-step assistance.

Import License Documents Required for MD15

Key documents for import license application include:

• Valid Manufacturing License (MD9) from the country of manufacture
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international approval
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Incorporation Proof

Timeline and Processing Duration

Government Fees and Costs

Manufacturing License (MD9):

• Application Fee: ₹50,000 per application
• Product Fee: ₹1,000 per product

Test License (MD13):

• Fees vary, generally included in application process

Import License (MD15):

• Site Fee: ₹3,000 per site
• Product Fee: ₹1,500 per product

These fees are payable online via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

• Challenge: Delays in product testing due to laboratory backlogs.

  • Solution: Engage with approved labs early; schedule sample submissions promptly. Use the CDSCO Testing Laboratories list.

• Challenge: Documentation gaps causing audit failures.

  • Solution: Prepare detailed Device and Plant Master Files; follow our comprehensive guides to avoid omissions.

• Challenge: Queries during audit leading to prolonged timelines.

  • Solution: Respond promptly and accurately to CDSCO queries; maintain open communication.

• Challenge: Misclassification of device risk leading to incorrect license application.

  • Solution: Confirm classification through CDSCO and refer to the Medical Device Classification guide.

Expert Consultation and Support

Our team has successfully guided over 500 manufacturers and importers through the CDSCO licensing maze. We offer:

• End-to-end application preparation and submission
• Device and Plant Master File development
• QMS and Risk Management implementation
• Pre-audit readiness checks
• Liaison with CDSCO and notified bodies

Partnering with an expert regulatory consultant can significantly reduce approval timelines and ensure compliance.

Getting Started with Your CDSCO License Application

To initiate your CDSCO license application for the implantable pulse generator mesh bag:

1. Confirm Device Classification: Verify Class D status and regulatory pathway.
2. Register on CDSCO MD Online Portal: Create an account on the official CDSCO MD Online Portal.
3. Apply for Test License (MD13): Submit application to produce samples for testing.
4. Select Testing Laboratory: Choose a CDSCO-approved lab for product testing.
5. Prepare Documentation: Assemble Device Master File, Plant Master File, Risk Management File, and other required documents.
6. Submit Manufacturing License Application (MD7): Once testing is complete, apply for the MD9 license.
7. Prepare for Audit: Ensure facility and QMS compliance for CDSCO inspection.

Taking these actionable steps with expert guidance will set you on the path to successfully manufacturing and importing this critical Class D neurological device in India.

For tailored support, connect with our regulatory consultants who bring 25+ years of industry experience to your project.