CDSCO License for Intraocular pressure-reducing system

Comprehensive Guide to CDSCO Licensing for Intraocular Pressure-Reducing Systems (Class C Ophthalmic Devices)

When manufacturing or importing an intraocular pressure-reducing system—an essential ophthalmic device designed to safely reduce intraocular pressure (IOP) via controlled external mechanical compression—understanding the CDSCO regulatory framework is crucial. This device is classified as Class C under the Indian medical device regulations, reflecting its moderate to high risk and critical role in surgical preparation.

With over 25 years of experience and having supported 500+ companies in securing their CDSCO licenses, we provide you with a detailed, step-by-step guide tailored specifically for Class C ophthalmic devices like yours.

CDSCO Regulatory Framework for Intraocular Pressure-Reducing Systems

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety, quality, and performance. Your device falls under the notified category as per Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021. This notification mandates compliance with the Medical Device Rules 2017, requiring manufacturers and importers to obtain appropriate licenses before marketing.

Risk Classification and License Requirements for Your Device

Intraocular pressure-reducing systems are categorized as Class C devices due to their direct interaction with sensitive ocular tissues and their role in surgical preparation. According to CDSCO’s classification:

• Class C devices require a Manufacturing License MD9 (application form MD7) granted by the Central Licensing Authority.
• Importers must obtain the Import License MD15 (application form MD14).

Understanding your device's risk class enables you to navigate the regulatory process efficiently.

Manufacturing License Process for Class C Devices (MD9 License)

The MD9 license process involves several key stages:

1. Test License (Form MD13): Initially, you must apply for a test license, allowing you to produce a limited quantity for testing. This takes approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing at government-approved laboratories to verify compliance with applicable standards. Refer to the list of testing laboratories approved by CDSCO.

3. Document Preparation and Submission: Compile comprehensive documentation, including technical files and quality management system (QMS) evidence.

4. Application for Manufacturing License (Form MD7): Submit your application through the CDSCO MD Online Portal.

5. Inspection and Audit: CDSCO inspectors will audit your manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).

6. Query Resolution: Address any observations or queries raised during the inspection or document review.

7. Grant of License (Form MD9): Upon satisfactory completion of all steps, the license will be issued.

The entire process typically spans 4 to 5 months.

Manufacturing License Documents Required for Intraocular Pressure-Reducing Systems

To ensure a smooth application, prepare the following comprehensive documentation:

• Company Constitution: Incorporation certificate, memorandum, and articles of association.
• Proof of Premises Ownership or Lease Agreement: Legal documents establishing your manufacturing site.
• Technical Staff Credentials: Qualifications and experience of key personnel.
• Fire Safety NOC and Pollution Control Board NOC: Compliance with environmental and safety regulations.
• Device Master File (DMF): Detailed design, specifications, and manufacturing process. Our Device Master File guide offers practical insights.
• Plant Master File (PMF): Describes the manufacturing environment and quality systems. Refer to our Plant Master File guide for assistance.
• Essential Principles Checklist: Conformity to applicable standards and principles.
• Risk Management File: Comprehensive risk analysis and mitigation strategies aligned with ISO 14971. Learn more about implementing risk management.
• Test Reports: From government-approved labs validating device safety and efficacy.
• Labels and Instructions for Use (IFU): Compliant with regulatory requirements.
• Quality Management System (QMS) Documents: ISO 13485 certification and SOPs.

Import License Process for Class C Devices (MD15 License)

If you intend to import the intraocular pressure-reducing system, obtaining the MD15 import license is mandatory. The process includes:

1. Document Preparation: Gather all required certificates and licenses.

2. Application Submission (Form MD14): File the application via the CDSCO MD Online Portal.

3. Query Resolution: Respond promptly to any queries from the licensing authority.

4. License Grant: The MD15 license is typically granted within 5 to 6 months.

Notably, unlike manufacturing licenses, a test license is not required for import applications.

Import License Documents Required

Prepare the following:

• Valid Manufacturing License from the Country of Origin
• Free Sale Certificate: Demonstrating market approval in the exporting country.
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution Documents

Timeline and Processing Duration

Planning your project timeline with these durations in mind will prevent costly delays.

Government Fees and Costs

Understanding the financial requirements upfront is key:

• MD9 Manufacturing License:

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

• MD15 Import License:

  • Class C Devices: $3,000 per site
  • $1,500 per product

• Test License (MD13):

  • Fees vary, typically minimal relative to manufacturing license costs

Additional costs include product testing, notified body audits, and consultancy fees if you engage expert assistance.

Common Challenges and Solutions

Challenge: Delays in test report approvals

Solution: Engage with CDSCO-approved testing labs early and submit samples promptly. Maintain consistent communication.

Challenge: Incomplete or inconsistent documentation

Solution: Use detailed checklists and consult our MD9 License Guide to ensure all documents meet CDSCO standards.

Challenge: Facility non-compliance during audit

Solution: Conduct internal mock audits and implement robust QMS prior to inspection.

Expert Consultation and Support

Navigating CDSCO regulations for Class C ophthalmic devices can be complex. Our seasoned regulatory consultants have a proven track record helping clients through every stage—from documentation to audit clearance. We provide:

• Gap analysis of your current compliance status
• Tailored document preparation support
• Liaison with CDSCO authorities and notified bodies
• Training and mock audits to guarantee readiness

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C status via the Medical Device Classification resource.

2. Initiate Test License Application (MD13): Start early to accommodate lab testing timelines.

3. Engage a CDSCO-Recognized Testing Laboratory: Select from the official list.

4. Prepare Comprehensive Technical Documentation: Leverage our Device and Plant Master File guides.

5. Submit Applications via the CDSCO MD Online Portal: Streamline your process through the CDSCO MD Online Portal.

6. Plan for Audit and Inspection: Schedule internal reviews and prepare your team.

By taking these targeted steps, manufacturers and importers can confidently enter the Indian market with their intraocular pressure-reducing systems, ensuring compliance, safety, and regulatory approval.

For personalized support and detailed assistance with your CDSCO licensing journey, contact our expert regulatory team today.