CDSCO License for Glaucoma supraciliary implant

Comprehensive Guide to CDSCO Licensing for Glaucoma Supraciliary Implant (Class C Medical Device)

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in successfully navigating the CDSCO licensing landscape, we understand the critical importance of compliance for medical devices like the Glaucoma supraciliary implant. This specialized ophthalmic device, classified as Class C under Indian regulations, requires meticulous adherence to the CDSCO framework to ensure timely market entry and sustained regulatory compliance.

Understanding the Glaucoma Supraciliary Implant and its Regulatory Significance

The Glaucoma supraciliary implant is a non-bioabsorbable synthetic polymer device designed to be implanted in the supraciliary space to facilitate aqueous humor outflow, thereby reducing intraocular pressure in patients with open-angle glaucoma. Classified as Class C due to its moderate to high risk profile, this device is governed by stringent regulatory controls under CDSCO to safeguard patient safety while enabling innovation in ophthalmology.

CDSCO Regulatory Framework for Glaucoma Supraciliary Implant

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices based on their risk classification. For a Class C device like the Glaucoma supraciliary implant, the regulatory pathway involves obtaining an MD9 manufacturing license granted by the Central Licensing Authority. This process encompasses comprehensive documentation, product testing, and audits to ensure compliance with Indian regulatory standards.

Risk Classification and License Requirements for Class C Ophthalmic Devices

• Risk Class: C (Moderate to high risk)
• License Type: MD9 Manufacturing License (Form MD7)
• Authority: Central Licensing Authority, CDSCO
• Applicable Notification: Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021

For detailed understanding of device classification, manufacturers can refer to the Medical Device Classification guide.

Step-by-Step Manufacturing License Process for MD9 License

1. Application for Test License (Form MD13):

   • Duration: Approximately 1.5 to 2 months
   • Purpose: To legally manufacture and test the device batches during the evaluation phase

2. Product Testing:

   • Must be conducted in government-approved laboratories
   • Access the list of Testing Laboratories approved by CDSCO
   • Testing includes biocompatibility, sterility, mechanical performance, and safety as per international and Indian standards

3. Preparation of Regulatory Documents:

   • Device Master File (DMF)
   • Plant Master File (PMF)
   • Essential Principles Checklist
   • Risk Management File
   • Quality Management System (QMS) documentation compliant with ISO 13485:2016

4. Submission of Application for Manufacturing License (Form MD7):

   • Submit via the CDSCO MD Online Portal

5. Audit by CDSCO Inspectors:

   • On-site verification of manufacturing premises, processes, and QMS

6. Resolution of Queries:

   • Respond promptly to any clarifications or requests for additional information

7. Grant of MD9 License (Form MD9):

   • Upon successful audit and document approval

For more detailed insights, our MD9 License Guide is an excellent resource.

Essential Documents Required for MD9 Manufacturing License Application

• Company Constitution and Registration Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification Documents
• Fire and Pollution NOCs
• Device Master File (DMF): Detailed device design, manufacturing process, and specifications (Device Master File Guide)
• Plant Master File (PMF): Manufacturing facility details (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance to safety and performance
• Risk Management File as per ISO 14971 (Risk Management)
• Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents aligned with ISO 13485

Import License Process (MD15) for Glaucoma Supraciliary Implant

For importers seeking to bring the Glaucoma supraciliary implant into India, the MD15 import license is mandatory. The process is managed by CDSCO’s Central Licensing Authority and includes:

• Preparation of necessary documents including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and Wholesale License
• Application submission via the CDSCO MD Online Portal
• Queries resolution and final grant of license

Typical timelines for MD15 licensing range between 5 to 6 months. For comprehensive guidance, consult our Import License Guide.

Timeline and Processing Duration for Class C Device Licensing

Total estimated time: Approximately 4 to 5 months

Government Fees and Costs Breakdown

• MD9 License Application Fee: INR 50,000 per application
• Product Fee: INR 1,000 per product (Glaucoma supraciliary implant counts as one product)

Additional costs to consider:

• Testing laboratory fees (varies by tests required)
• Notified body audit fees
• Consultancy fees if availing expert support

All fees are payable via the CDSCO MD Online portal during application submission.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

• Solution: Early engagement with CDSCO-approved testing laboratories and pre-scheduling tests can mitigate delays.

Challenge 2: Incomplete or Non-compliant Documentation

• Solution: Utilize comprehensive checklists for DMF, PMF, and risk management files; leverage expert consultants to audit documents prior to submission.

Challenge 3: Audit Non-conformities

• Solution: Conduct internal pre-audits and ensure QMS compliance with ISO 13485 to streamline CDSCO inspections.

Challenge 4: Query Resolution Delays

• Solution: Maintain a dedicated regulatory team to respond promptly and accurately to CDSCO queries.

Expert Consultation and Support

With over two decades of experience, our team offers tailored consultancy services to expedite your CDSCO licensing process for ophthalmic devices like the Glaucoma supraciliary implant. We assist with:

• Detailed gap analysis and readiness assessment
• Document preparation and review
• Coordination with testing labs and notified bodies
• Application submission and follow-up
• Audit readiness and post-audit support

Getting Started with Your CDSCO License Application for Glaucoma Supraciliary Implant

1. Assess Your Device Classification: Confirm Class C designation and regulatory pathway.
2. Prepare Test License Application (Form MD13): Initiate manufacturing for testing purposes.
3. Engage Approved Testing Laboratories: Plan and conduct requisite product tests.
4. Compile Comprehensive Documentation: Develop DMF, PMF, Risk Management File, and QMS documents.
5. Submit Application for MD9 License (Form MD7): Use the official CDSCO MD Online Portal for submission.
6. Prepare for CDSCO Audit: Ensure your manufacturing facility and processes are audit-ready.
7. Respond to Queries Promptly: Maintain proactive communication with CDSCO for faster approvals.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can successfully navigate the CDSCO licensing process for the Glaucoma supraciliary implant, ensuring compliance and timely market access in India.