CDSCO License for Conjunctival scissors

Comprehensive Guide to CDSCO License for Conjunctival Scissors (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having guided 500+ companies through the CDSCO licensing maze, we understand the intricacies involved in bringing medical devices like conjunctival scissors to the Indian market. This hand-held ophthalmic surgical instrument, classified as a Class A device under the CDSCO framework, requires meticulous regulatory compliance to ensure safety, quality, and legal market access.

Introduction to Conjunctival Scissors and Regulatory Importance

Conjunctival scissors are specialized manual instruments designed to cut the conjunctiva and Tenon’s capsule carefully during ophthalmic surgeries. Given their direct contact with ocular tissues, regulatory oversight is essential to guarantee that these devices meet stringent quality and safety standards. The CDSCO notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021 formally classifies conjunctival scissors as a Class A medical device under the ophthalmology category.

CDSCO Regulatory Framework for Conjunctival Scissors

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Conjunctival scissors, being Class A devices, fall under the jurisdiction of the State Licensing Authority. Manufacturers must obtain the MD5 manufacturing license (Form MD3) before commencing production.

Risk Classification and License Requirements for Class A Devices

Class A devices are deemed low risk, but compliance is non-negotiable. The MD5 license is the pathway for manufacturing and marketing conjunctival scissors. This involves:

• Obtaining a test license (Form MD13) to conduct mandatory product testing
• Product evaluation through government-approved testing laboratories
• Audit by a notified body
• Submission of comprehensive documentation

For more on device classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process (MD5) for Conjunctival Scissors

1. Apply for Test License (Form MD13): The first step is to secure a test license, which allows you to send samples for testing. This process typically takes 1.5 to 2 months.
2. Product Testing: Samples must be tested in CDSCO-approved laboratories to verify compliance with safety and performance standards. Access the list of Testing Laboratories.
3. Documentation Preparation: Prepare all required documents including Device Master File, Plant Master File, and quality management system details.
4. Application Submission (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body approved by CDSCO. Check the Notified Bodies List.
6. Resolution of Queries: Address any queries raised during audit or document review promptly.
7. Grant of MD5 License: On successful completion, the license is issued in Form MD5.

Manufacturing License Documents Required for Class A Devices

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Details of Qualified Technical Staff
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailed design, manufacturing process, and specifications. For guidance, see our Device Master File Guide.
• Plant Master File (PMF): Facility layout, equipment, and quality controls. Learn more at our Plant Master File Guide.
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File showing identification and mitigation of device risks (see our Risk Management insights)
• Test Reports from government-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485 compliance recommended)

Import License Process (MD15) for Conjunctival Scissors

If you are an importer rather than a manufacturer, the import license (MD15) must be secured from the Central Licensing Authority. The process involves:

• Preparation of supporting documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate
• Submission of Form MD14 application via the CDSCO MD Online Portal
• Resolution of departmental queries
• License grant typically within 5-6 months

For detailed import licensing, explore our Import License Guide.

Import License Documents Required

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

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 month (may overlap with test license period)
• Document Preparation: 2-3 weeks
• MD5 License Application Review & Audit: 1 to 1.5 months
• Total Duration: Approximately 3 to 4 months for the complete manufacturing license process

Government Fees and Costs

• Test License Fee: Included within overall costs
• MD5 License Fees: Rs. 5000 per application + Rs. 500 per product
• Additional costs include testing laboratory fees, notified body audit charges, and consultant fees if applicable

Common Challenges and Solutions

• Incomplete Documentation: Prepare documents meticulously; use checklists and expert reviews.
• Delayed Testing Results: Engage with government-approved labs early and follow up regularly.
• Audit Non-Compliance: Perform internal pre-audits to identify gaps and resolve them before notified body visits.
• Regulatory Queries: Respond promptly and with detailed evidence to avoid delays.

Expert Consultation and Support

With our extensive track record, we offer tailored consulting to streamline your CDSCO licensing journey. From document preparation to audit readiness, our experts ensure smooth compliance, saving you time and cost.

Getting Started with Your CDSCO License Application for Conjunctival Scissors

1. Assess Your Readiness: Conduct a gap analysis of your current manufacturing setup against CDSCO requirements.
2. Engage a Testing Laboratory: Select a CDSCO-approved lab early; coordinate sample submission.
3. Prepare Device and Plant Master Files: Invest time in comprehensive documentation—our guides linked above can help.
4. Apply for Test License (MD13): Submit your initial application via the CDSCO MD Online Portal.
5. Plan for Audit: Schedule pre-audit checks and notify a suitable notified body.
6. Budget for Fees and Timelines: Allocate resources for fees, testing, audits, and potential consultancy.

By following these actionable steps, manufacturers of conjunctival scissors can confidently navigate the CDSCO licensing process, ensuring timely market entry and compliance with Indian regulations.

For personalized assistance or to discuss your specific case, contact our regulatory experts who have successfully supported over 500 medical device companies in India.