CDSCO License for Capsular tension ring

Comprehensive Guide to CDSCO Licensing for Capsular Tension Rings (Class C Medical Device)

Capsular Tension Rings, designed to mechanically stabilize a subluxated crystalline lens capsule in cases of weak or absent zonules, are critical devices in ophthalmic oncology. Given their specialized use and moderate risk classification (Class C), obtaining the appropriate CDSCO licenses is essential for manufacturers and importers seeking to enter the Indian medical device market.

With over 25 years of regulatory experience and having assisted 500+ companies to secure CDSCO approvals, we provide you with a detailed, step-by-step guide tailored specifically for your Capsular Tension Ring device.

CDSCO Regulatory Framework for Capsular Tension Rings

Medical devices in India are regulated under the Medical Device Rules (MDR), 2017, overseen by the Central Drugs Standard Control Organization (CDSCO). Capsular Tension Rings fall under Class C due to their invasive nature and potential impact on patient safety.

Your device notification details:

• File No.: 29/Misc./03/2020-DC (153) — Part 1
• Notification Date: 11.10.2022

This categorization mandates compliance with stringent regulatory requirements, including licensing, quality management, and post-market surveillance.

Risk Classification and License Requirements for Class C Devices

Class C devices are considered moderate to high risk and require a manufacturing license under MD9 (Form MD7) issued by the Central Licensing Authority. Similarly, imports require an MD15 license.

• Manufacturing License (MD9): Central approval with a process duration of approximately 4-5 months.
• Import License (MD15): Central approval with a process duration of approximately 5-6 months.

For detailed classification criteria, refer to our Medical Device Classification resource.

Manufacturing License Process (MD9) for Capsular Tension Rings

Step 1: Apply for Test License (Form MD13)

Before applying for the MD9 license, manufacturers must obtain a test license on Form MD13. This test license allows sample testing of your product at government-approved labs.

• Duration: 1.5 to 2 months
• Testing: Conducted at notified laboratories listed on the CDSCO Testing Laboratories portal

Step 2: Product Testing

Submit your Capsular Tension Ring samples for testing against Indian standards and Essential Principles. This ensures safety, efficacy, and compliance with regulatory norms.

Step 3: Documentation Preparation

Prepare comprehensive documentation, including the Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, risk management files, and clinical evaluation reports.

• Our Device Master File Guide and Plant Master File Guide offer in-depth insights.

Step 4: Submit Application on CDSCO MD Online Portal

Apply for the MD9 license on the CDSCO MD Online Portal using Form MD7.

Step 5: CDSCO Audit and Inspection

CDSCO inspectors will audit your manufacturing facility and review submitted documents to verify compliance.

Step 6: Query Resolution

Address any queries raised by the CDSCO or auditors promptly to prevent delays.

Step 7: License Grant

Upon successful audit and document verification, the MD9 license will be granted.

Manufacturing License Documents Required for MD9

• Company Constitution (e.g., Certificate of Incorporation)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File compliant with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016

Ensure all documents are up-to-date, accurate, and aligned with the notified device specifications.

Import License Process (MD15) for Capsular Tension Rings

Step 1: Document Preparation

Compile all required documentation, including the manufacturing license, Free Sale Certificate from the country of origin, ISO 13485:2016 certificate, CE certificate (if applicable), and device-specific documents.

Step 2: Application Submission

Submit your import license application on the CDSCO MD Online Portal using Form MD14.

Step 3: Query Resolution

Respond promptly to any queries from CDSCO to avoid prolonging the process.

Step 4: License Grant

Upon satisfactory evaluation, CDSCO will issue the MD15 import license.

Import License Documents Required for MD15

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

Timeline and Processing Duration

Realistically, manufacturers should plan for a total of 5 to 7 months from test license application to manufacturing license issuance.

Government Fees and Costs

*Note: MD15 fees are prescribed in USD as per CDSCO guidelines.

Additional costs include testing fees at government labs, audit fees payable to notified bodies, and consultancy fees if you engage expert support.

Common Challenges and Solutions

Challenge 1: Incomplete or Non-compliant Documentation

Solution: Engage expert consultants to review your DMF, PMF, and QMS documents. Utilize our detailed guides to ensure completeness.

Challenge 2: Delays in Product Testing

Solution: Choose notified testing laboratories with shorter lead times from the CDSCO Testing Laboratories list and prepare samples meticulously.

Challenge 3: Audit Non-conformities

Solution: Conduct internal audits and mock inspections ahead of CDSCO visits. Ensure your facility complies with GMP and ISO 13485 standards.

Challenge 4: Query Resolution Delays

Solution: Maintain a dedicated regulatory team to address queries immediately and provide comprehensive responses.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like Capsular Tension Rings requires specialized knowledge. Our team has supported over 500 companies through:

• Regulatory strategy development
• Document preparation and gap analysis
• Audit readiness and compliance training
• Liaison with CDSCO and notified bodies

Our proven approach minimizes delays and ensures a smooth approval process.

Getting Started with Your CDSCO License Application

1. Assess your device classification and applicable rules. Confirm your Capsular Tension Ring is Class C as per CDSCO notification.
2. Initiate Test License (MD13) application on the CDSCO MD Online Portal.
3. Identify and engage with a government-approved testing laboratory early to schedule product testing.
4. Prepare comprehensive documentation including Device Master File, Plant Master File, and risk management reports.
5. Plan for the CDSCO audit by selecting a notified body if required and conducting internal readiness checks.
6. Submit your MD9 manufacturing license application upon successful testing.
7. Once manufacturing license is granted, prepare import license (MD15) application with all requisite documents.

Starting early and maintaining clear timelines is crucial for timely regulatory approvals.

For detailed step-by-step support, please contact our regulatory consulting team to leverage our 25+ years of experience and ensure your Capsular Tension Ring obtains CDSCO approval with minimal hassle.