CDSCO License for Corneal inlay, aperture reducing

Comprehensive Guide to CDSCO Licensing for Corneal Inlay (Aperture Reducing) Devices in Ophthalmology

As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the intricacies involved in obtaining CDSCO licenses for specialized medical devices like the Corneal Inlay (aperture reducing). This implantable ophthalmic device, classified as Class C due to its invasive nature and impact on vision correction, requires careful navigation through India's regulatory framework to ensure timely market entry.

Understanding the Device and Regulatory Importance

The Corneal Inlay is an implantable device inserted into the natural cornea to treat presbyopia by reducing the aperture, thereby improving near vision. Given its direct interaction with ocular tissues and potential risks, it falls under Class C as per CDSCO's notified devices list (Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021).

Regulatory compliance is critical—not only to meet legal mandates but also to ensure patient safety, product quality, and credibility in the Indian market. Securing the appropriate CDSCO license enables manufacturers and importers to market and distribute this advanced ophthalmic device across India.

CDSCO Regulatory Framework for Corneal Inlay Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, with classification into four risk classes (A to D). Corneal Inlay devices, being Class C, are subject to stringent controls to ensure safety and efficacy.

For Class C devices, the license is issued centrally by the CDSCO under the MD9 license category, governed by Form MD7 for application and Form MD9 for license grant. The process mandates adherence to testing, audit, and documentation standards.

Risk Classification and License Requirements for Corneal Inlay

• Risk Class: C (Medium-high risk)
• License Type: MD9 Manufacturing License
• Regulatory Authority: Central Licensing Authority (CDSCO Headquarters, New Delhi)

Manufacturers must obtain the MD9 license if producing the device domestically. Importers require the MD15 import license, which involves a separate application process.

Step-by-Step Manufacturing License Process (MD9)

Obtaining an MD9 license involves several sequential steps:

1. Test License (Form MD13):

   • Apply for a test license that permits sample production for testing purposes.
   • Processing Time: Approximately 1.5 to 2 months.

2. Product Testing:

   • Conduct testing at CDSCO-approved government or notified laboratories to verify safety and performance.
   • Refer to the list of testing laboratories for authorized facilities.

3. Document Preparation:

   • Compile comprehensive technical documentation, including Device Master File, Plant Master File, Risk Management, and Essential Principles checklist.

4. License Application (Form MD7):

   • Submit the MD9 license application through the CDSCO MD Online Portal.

5. Audit by CDSCO Inspectors:

   • Undergo a detailed audit of manufacturing premises, quality systems, and technical compliance.

6. Query Resolution:

   • Address any queries raised by CDSCO or auditors promptly to avoid delays.

7. License Grant (Form MD9):

   • Upon satisfactory compliance, receive the manufacturing license.

Detailed Manufacturing License Documents Required

For a Class C Corneal Inlay device, the following documents are mandatory:

• Company Constitution Documents: Incorporation certificate, partnership deed, or LLP agreement.
• Proof of Ownership/Lease of Manufacturing Premises: Valid property documents.
• Technical Staff Credentials: CVs and qualification certificates of key personnel (R&D, QA, QC, production).
• Fire NOC: No Objection Certificate from fire department.
• Pollution Control NOC: From relevant state pollution control board.
• Device Master File (DMF): Detailed design, specifications, manufacturing process, and validation reports. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Manufacturing facility details aligned with regulatory standards. Refer to our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with Indian medical device standards.
• Risk Management File: Per ISO 14971 principles, specific to the Corneal Inlay. For implementation tips, see our Risk Management guide.
• Test Reports: From CDSCO-approved labs confirming device safety and performance.
• Labels and Instructions for Use (IFU): Compliant with labeling regulations.
• Quality Management System (QMS) Documents: ISO 13485 certification and internal quality manuals.

Import License Process for Corneal Inlay Devices (MD15)

Importers intending to bring Corneal Inlay devices into India must apply for the MD15 import license. The process includes:

• Document Preparation: Including existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE certificate, DMF, PMF, wholesale license, and company constitution.
• Application Submission: Using Form MD14 on the CDSCO MD Online Portal.
• Query Resolution: Responding to CDSCO queries.
• License Grant: Issuance of MD15 license.

The entire process typically takes 5-6 months.

Timeline and Processing Duration

Proactive query management and thorough documentation can help prevent delays.

Government Fees and Costs

• MD9 License Application Fee: ₹50,000 per application.
• Product Fee: ₹1,000 per product.
• Additional Costs:
  • Testing fees at approved laboratories (varies by test scope).
  • Notified body audit fees.

Budgeting for these costs upfront ensures smooth financial planning.

Common Challenges and Practical Solutions

• Delayed Test Results: Opt for reputed CDSCO-approved labs with proven turnaround times.
• Incomplete Documentation: Use detailed checklists and consult experts to avoid omissions.
• Audit Non-Compliance: Conduct pre-audit internal assessments to identify gaps.
• Query Overload: Maintain open communication with CDSCO and address queries in a timely, organized manner.

Our extensive experience means we anticipate such hurdles and guide clients to preemptively mitigate them.

Expert Consultation and Support

Navigating the MD9 license process for Class C devices like the Corneal Inlay requires specialized knowledge. Our consultancy provides:

• Tailored document preparation assistance.
• Pre-audit readiness evaluations.
• Liaison with CDSCO officials and notified bodies.
• Training on regulatory updates and compliance.

For detailed guidance, explore our MD9 License Guide which outlines every necessary step.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C status using the Medical Device Classification tool.
2. Initiate Test License Application: Begin with Form MD13 on the CDSCO MD Online Portal.
3. Prepare Comprehensive Documentation: Leverage our Device and Plant Master File guides for structured preparation.
4. Select Accredited Testing Labs: Refer to the official list to ensure compliance.
5. Plan for Audit Readiness: Engage with notified bodies early to schedule audits.

Embarking on the CDSCO licensing journey with expert support maximizes your chances of a smooth and successful approval process. Contact us to streamline your Corneal Inlay device’s regulatory pathway and confidently enter the Indian ophthalmology market.