CDSCO License for Ophthalmic cryosurgical system

Comprehensive Guide to CDSCO Licensing for Ophthalmic Cryosurgical Systems (Class C)

As a trusted regulatory consultancy with over 25 years of experience and a track record of assisting 500+ companies, we understand the complexities manufacturers and importers face when navigating the CDSCO licensing process in India. This guide focuses on the Ophthalmic Cryosurgical System, a Class C medical device used in ophthalmology, and provides detailed, actionable insights to help you secure your CDSCO license efficiently.

Introduction: Ophthalmic Cryosurgical System and Regulatory Importance

The ophthalmic cryosurgical system is a specialized assembly designed to deliver extreme cold to targeted ocular tissues, facilitating their destruction and removal during surgical procedures. Given its invasive nature and potential risks associated with tissue damage and patient safety, this device falls under Class C in the CDSCO risk classification framework. Consequently, stringent regulatory controls apply to ensure safety, efficacy, and quality.

Obtaining the correct CDSCO license is not only a legal mandate but also a benchmark of trust and compliance, enabling manufacturers and importers to confidently market their ophthalmic cryosurgical systems across India.

CDSCO Regulatory Framework for Ophthalmic Cryosurgical Systems

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR), 2017. Ophthalmic cryosurgical systems are classified as Class C due to their moderate to high risk.

For Class C devices, the MD9 manufacturing license is mandatory for domestic manufacturers, while importers require the MD15 import license. These licenses are issued by the Central Licensing Authority (CLA), following a comprehensive evaluation process that includes product testing, documentation review, and facility inspection.

Risk Classification and License Requirements

Refer to the detailed Medical Device Classification guide for more on risk categorization.

Manufacturing License Process (MD9) for Ophthalmic Cryosurgical Systems

1. Test License Application (Form MD13):

   • Initiate by applying for a test license to conduct product testing.
   • This step takes approximately 1.5 to 2 months.

2. Product Testing:

   • Get your ophthalmic cryosurgical system tested at a CDSCO-approved government testing laboratory.
   • Explore the list of approved testing laboratories to select a facility.

3. Documentation Preparation:

   • Compile all required documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. License Application Submission (Form MD7):

   • Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors:

   • Post submission, an on-site audit is conducted to verify compliance with MDR and Good Manufacturing Practices.

6. Queries Resolution:

   • Address any queries or deficiencies raised by the authority or auditors promptly.

7. License Grant (Form MD9):

   • Upon satisfactory review, the MD9 manufacturing license is granted.

For a detailed stepwise process, consult the MD9 License Guide.

Manufacturing License Documents Required for Ophthalmic Cryosurgical Systems

• Company Constitution (MoA and AoA)
• Proof of ownership or lease agreement of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) — see our Device Master File guide
• Plant Master File (PMF) — detailed in our Plant Master File guide
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File as per ISO 14971 standards (Risk Management Guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, including ISO 13485:2016 certification

Import License Process (MD15) for Ophthalmic Cryosurgical Systems

Unlike manufacturing licenses, the import license for Class C devices does not require a test license. The process involves:

1. Document Preparation:

   • Gather all necessary documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, and detailed Device and Plant Master Files.

2. Application Submission (Form MD14):

   • File the application via the CDSCO MD Online Portal.

3. Queries Resolution:

   • Promptly respond to any queries from the CDSCO.

4. License Issuance (Form MD15):

   • Upon fulfillment of all criteria, the import license is granted by the Central Licensing Authority.

For an in-depth walkthrough, refer to our Import License Guide.

Import License Documents Required

• Valid Manufacturing License of the product from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale license in India
• Company Constitution documents
• Evidence of compliance with Indian MDR

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License:

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

• MD15 Import License:

  • Site Fee: $3,000 (approx ₹2,50,000 INR)
  • Per Product Fee: $1,500 (approx ₹1,25,000 INR)

Note: Fees are subject to change as per CDSCO notifications. Always confirm current fees on the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delay in Product Testing:

  • Challenge: Limited slots at government-approved labs can cause bottlenecks.
  • Solution: Early booking with labs and considering alternate approved labs can mitigate delays.

• Incomplete Documentation:

  • Challenge: Missing or non-compliant documents often trigger queries.
  • Solution: Utilize professional checklists and expert consultation to ensure completeness.

• Audit Non-compliance:

  • Challenge: Deficiencies found during the audit can delay license issuance.
  • Solution: Conduct internal audits and mock inspections beforehand.

• Query Response Delays:

  • Challenge: Slow response to CDSCO queries prolongs timelines.
  • Solution: Establish a dedicated regulatory team to handle queries promptly.

Expert Consultation and Support

Navigating the CDSCO licensing landscape requires expertise and experience. We offer tailored consultancy services that include:

• Comprehensive gap analysis and readiness assessment
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• End-to-end application filing and follow-up
• Training on post-market compliance and vigilance

Our proven approach has helped over 500 companies successfully obtain licenses for complex devices like ophthalmic cryosurgical systems.

Getting Started with Your CDSCO License Application for Ophthalmic Cryosurgical Systems

1. Assess Your Product Classification: Confirm your device is Class C per CDSCO guidelines.

2. Prepare Documentation: Begin compiling your DMF, PMF, Risk Management File, and QMS documents.

3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to initiate product testing.

4. Engage Testing Laboratories: Schedule your product testing at a CDSCO-approved lab.

5. Plan for Audit: Align your manufacturing site and processes with MDR requirements ahead of the CDSCO inspection.

6. Submit License Application: Once testing and documentation are complete, apply for the MD9 license using Form MD7.

7. Monitor Application: Track your application status online and respond promptly to queries.

By following these strategic steps and leveraging expert guidance, you can significantly reduce the time and effort required to enter the Indian market with your ophthalmic cryosurgical system.

For personalized assistance and comprehensive support throughout your CDSCO licensing journey, contact our regulatory experts today.