CDSCO License for Intervertebral disc prolapse therapy pack

Introduction to Intervertebral Disc Prolapse Therapy Pack and Its Regulatory Importance

The Intervertebral Disc Prolapse Therapy Pack is a Class B medical device designed specifically for pain management. Intended for topical application on the skin over the cervical or lumbar spine, it helps alleviate pain caused by prolapsed (herniated) intervertebral discs. Given its therapeutic purpose and risk classification, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing or manufacturing in India.

Navigating the CDSCO licensing process can be complex, but with over 25 years of experience and having assisted over 500 companies, we provide you with a practical roadmap to secure your MD5 manufacturing license efficiently and cost-effectively.

CDSCO Regulatory Framework for Intervertebral Disc Prolapse Therapy Packs

The CDSCO classifies medical devices based on risk, intended use, and duration of contact with the body. Your device falls under Class B (low-moderate risk), which mandates registration and licensing at the state level under the MD5 license category. The regulatory journey involves compliance with the Medical Device Rules, 2017, and adherence to quality and safety standards.

Risk Classification and License Requirements for Class B Devices

Class B devices, including your Intervertebral Disc Prolapse Therapy Pack, require a manufacturing license under Form MD5 issued by the State Licensing Authority. This classification reflects the moderate risk associated with topical pain relief devices.

Key steps include:

• Obtaining a Test License (Form MD13) to initiate product testing
• Product testing at CDSCO-approved labs
• Submission of technical and quality documentation
• Facility audit by a notified body
• Final license grant in Form MD5

The entire cycle typically spans 3 to 4 months.

Manufacturing License Process (MD5) for Your Device

1. Test License Application (Form MD13): Submit your application via the CDSCO MD Online Portal to get test license approval, which takes about 1.5 to 2 months.

2. Product Testing: Conduct product testing at government-approved laboratories. Verify testing labs from the official Testing Laboratories list to ensure compliance.

3. Documentation Preparation: Prepare and collate all necessary documents including Device Master File, Plant Master File, risk management files, and QMS documents.

4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 license after successful product testing.

5. Audit by Notified Body: An audit by a notified body listed on the Notified Bodies List is mandatory before license approval.

6. Resolution of Queries: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License: Upon satisfactory audit and document review, the license is granted in Form MD5.

For comprehensive guidance, refer to our detailed MD5 License Guide.

Manufacturing License Documents Required

To support your MD5 license application, the following documents must be meticulously prepared:

• Company Constitution Documents: Incorporation certificate, Memorandum and Articles of Association
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualifications and Experience Certificates
• Fire and Pollution NOCs: To comply with local regulations
• Device Master File (DMF): Detailed device specifications, manufacturing process, and safety data. Our Device Master File guide simplifies this step.
• Plant Master File (PMF): Documentation of your manufacturing facility’s infrastructure and quality measures. Learn more in our Plant Master File Guide.
• Essential Principles Checklist: Demonstrating compliance with Indian Medical Device Rules
• Risk Management File: Specific to your device risk profile
• Test Reports: From government-approved testing laboratories
• Labels & Instructions for Use (IFU): Compliant with regulatory requirements
• Quality Management System (QMS) Documents: ISO 13485 certification and internal SOPs

Import License Process (MD15) for Intervertebral Disc Prolapse Therapy Packs

If you are an importer rather than a manufacturer, you must obtain the MD15 import license from CDSCO Central Licensing Authority. This process is slightly different:

• No test license is required
• Submit application in Form MD14 through the CDSCO MD Online Portal
• Provide documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device & Plant Master Files, wholesale license, and company constitution
• Timeline for approval is approximately 5 to 6 months

For detailed import procedures, our Import License Guide is an invaluable resource.

Import License Documents Required

• Valid manufacturing license of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale drug license
• Company Constitution documents

Timeline and Processing Duration

Total estimated time: 3 to 4 months

Government Fees and Costs

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs to budget for:

• Testing fees at government-approved laboratories (variable, typically Rs 50,000 to Rs 1,00,000 depending on test scope)
• Notified body audit fees (varies by body, generally Rs 50,000 to Rs 1,50,000)
• Consultancy or expert assistance fees if you engage external support

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with CDSCO-approved labs early and confirm test scope. Maintain constant communication to avoid bottlenecks.

Challenge 2: Insufficient Documentation

• Solution: Prepare complete Device and Plant Master Files based on standard templates. Our guides can streamline this process.

Challenge 3: Audit Non-compliance

• Solution: Conduct internal audits before notified body visits. Ensure QMS and premises meet regulatory standards.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated regulatory personnel to respond promptly and accurately to CDSCO or notified body queries.

Expert Consultation and Support

With 25+ years in medical device regulatory affairs and more than 500 successful CDSCO licensing projects, we offer tailored consulting to simplify your MD5 license journey. Our services include:

• Comprehensive gap analysis
• Documentation preparation and review
• End-to-end application management
• Coordination with notified bodies and testing labs

Our expertise helps manufacturers avoid common pitfalls and expedites license approval.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm the Class B status using the CDSCO classification rules. Our Medical Device Classification guide can assist.

2. Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the application interface.

3. Prepare Test License Application: Collate preliminary documents and apply for the test license (Form MD13).

4. Engage CDSCO-approved Testing Laboratories: Schedule testing early to avoid delays.

5. Develop Required Documentation: Begin preparing your Device and Plant Master Files, Risk Management, and QMS documents simultaneously.

6. Plan for the Notified Body Audit: Select a notified body from the official Notified Bodies List and schedule your audit.

7. Submit Manufacturing License Application (Form MD3): After successful testing and documentation readiness, apply for the MD5 license.

8. Respond to Queries Promptly: Assign a regulatory coordinator to track and resolve queries from CDSCO or auditors.

By following these actionable steps and leveraging expert support, you can confidently navigate the CDSCO licensing process for your Intervertebral Disc Prolapse Therapy Pack.

For personalized assistance or to discuss your specific project, please contact us. Together, we can ensure your pain management device reaches the Indian market compliantly and efficiently.