CDSCO License for Scleral buckling device

Comprehensive Guide to CDSCO Licensing for Scleral Buckling Devices (Class C Ophthalmology Device)

Scleral buckling devices are critical ophthalmic implants designed to treat retinal detachment by compressing the sclera. Given their implantable nature and significant clinical impact, these devices fall under Class C risk category as per CDSCO regulations. Navigating the regulatory landscape for such devices in India requires a thorough understanding of the CDSCO licensing framework tailored for Class C medical devices.

With over 25 years of experience assisting 500+ medical device companies, we provide an authoritative, step-by-step guide to obtaining your CDSCO MD9 manufacturing license and import license for scleral buckling devices, ensuring smooth market entry and compliance.

CDSCO Regulatory Framework for Scleral Buckling Devices

The Central Drugs Standard Control Organization (CDSCO) is the apex national regulatory body governing medical devices’ approval in India. Scleral buckling devices fall under the notified category of ophthalmology devices with Notification Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021, categorizing them as Class C devices due to their implantable nature and medium to high risk.

Manufacturers and importers must adhere to CDSCO’s stringent requirements, including product testing, documentation, quality management system (QMS) compliance, and audits before market authorization.

Risk Classification and License Requirements for Scleral Buckling Devices

Class C devices such as scleral buckling devices are considered medium to high risk, necessitating a manufacturing license under Form MD7 (MD9 license) issued by the Central Licensing Authority (CLA). This is a comprehensive process that includes:

• Obtaining a Test License (Form MD13)
• Product testing at CDSCO-approved laboratories
• Document submission and review
• On-site audit by CDSCO inspectors
• Addressing queries and final approval

The entire process typically spans 4 to 5 months.

Manufacturing License Process (MD9) for Class C Scleral Buckling Devices

1. Test License Application (Form MD13): Before full manufacturing license application, companies must secure a test license to legally manufacture samples for testing. This phase takes about 1.5 to 2 months.

2. Product Testing: Samples are tested at government-approved testing laboratories for compliance with Indian standards. Refer to the Testing Laboratories list for approved facilities.

3. Document Preparation: Compile all mandatory documents including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and QMS documentation.

4. License Application Submission: Submit Form MD7 via the CDSCO MD Online Portal for the MD9 license.

5. Audit and Inspection: CDSCO officials conduct an on-site audit verifying compliance with Good Manufacturing Practices (GMP), QMS, and technical documentation.

6. Query Resolution: Address any queries or deficiencies raised during audit or document review promptly.

7. Grant of License (Form MD9): Upon satisfactory compliance, the license is granted enabling commercial manufacturing.

For detailed guidance, review our MD9 License Guide.

Manufacturing License Documents Required for MD9

Applicants must prepare the following key documents:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical staff qualifications and experience certificates
• No Objection Certificates (NOC) for Fire Safety and Pollution Control
• Device Master File (DMF) detailing design, materials, manufacturing process (Device Master File Guide)
• Plant Master File (PMF) describing facility layout, equipment, and QMS (Plant Master File Guide)
• Risk Management File aligned with ISO 14971 principles (Risk Management Guide)
• Essential Principles Compliance Checklist
• Product Test Reports from CDSCO-approved labs
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 certified

Import License Process (MD15) for Scleral Buckling Devices

For importers of scleral buckling devices, CDSCO issues an import license under Form MD15. Unlike manufacturing licenses, no test license is required. The process includes:

1. Document Preparation: Compile mandatory documents such as Manufacturer’s License, Free Sale Certificate from country of origin, ISO 13485:2016 certification, CE Certificate, DMF, PMF, wholesale license, and company constitution.

2. License Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution: Address any clarifications raised by CDSCO promptly.

4. Grant of Import License (Form MD15): Typically takes 5 to 6 months.

The applicable fee for Class C & D devices is USD 3000 per site plus USD 1500 per product.

For more details, our Import License Guide offers extensive insights.

Timeline and Processing Duration

Total duration: 4 to 5 months for manufacturing license.

Import license processing is longer, approximately 5 to 6 months.

Government Fees and Costs for Scleral Buckling Devices

• MD9 Manufacturing License:

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

• MD15 Import License:

  • Site Fee: USD 3,000
  • Per Product Fee: USD 1,500

Additional costs include:

• Product testing fees at approved labs
• Audit and consultancy fees (if applicable)
• Preparation of detailed technical documentation

Budgeting realistically for these expenses upfront will streamline your regulatory journey.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved labs early and schedule sample submission promptly. Refer to the Testing Laboratories list to select efficient labs.

Challenge 2: Incomplete or Non-compliant Documentation

Solution: Utilize comprehensive document templates and follow our Device Master File and Plant Master File guides to ensure completeness.

Challenge 3: Audit Non-conformities

Solution: Conduct internal audits aligned with CDSCO expectations and train your technical staff thoroughly.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory affairs specialist to handle timely and accurate responses.

Expert Consultation and Support

Navigating CDSCO licensing for Class C devices like scleral buckling devices is complex but manageable with expert guidance. Our team offers:

• Pre-application gap analysis
• Document preparation and review
• Coordination with notified bodies and testing labs
• Audit readiness support
• Query management and follow-up

Partnering with an experienced regulatory consultant reduces risk and accelerates time-to-market.

Getting Started with Your CDSCO License Application

1. Classify your device accurately: Confirm your scleral buckling device is Class C as per the Medical Device Classification.

2. Register on the CDSCO MD Online Portal: Create your organizational profile and familiarize yourself with submission workflows.

3. Initiate Test License Application: Prepare and submit Form MD13 for the test license.

4. Engage with Testing Laboratories: Submit samples for testing promptly after test license approval.

5. Compile Essential Documentation: Utilize our detailed guides and templates to develop your DMF, PMF, Risk Management File, and QMS.

6. Submit MD9 License Application: Once testing is complete and documents are ready, apply via Form MD7.

7. Prepare for Audit: Conduct internal inspections and training before the CDSCO audit.

8. Respond to Queries: Maintain proactive communication during the review phase.

By following these actionable steps and leveraging our expert support, your company can efficiently navigate the CDSCO licensing process for scleral buckling devices and successfully enter the Indian ophthalmology market.

For personalized assistance, connect with our regulatory consulting team today and benefit from our 25+ years of proven expertise.