CDSCO License for Intracorneal ring

Regulatory Overview for Intracorneal Ring: Essential CDSCO Licensing Insights

Intracorneal rings are implantable ophthalmic devices designed to correct mild to moderate myopia by flattening the anterior corneal curvature without affecting the visual axis. Classified as Class C medical devices under CDSCO guidelines, these devices fall into a higher risk category due to their implantable nature and direct interaction with sensitive ocular tissues. Obtaining the appropriate CDSCO license is crucial for manufacturers and importers aiming to legally market intracorneal rings in India.

With over 25 years of experience and having supported 500+ companies in navigating CDSCO approvals, we provide an in-depth, practical guide tailored specifically for intracorneal ring manufacturers and importers.

CDSCO Regulatory Framework for Intracorneal Rings (Class C)

The Central Drugs Standard Control Organization regulates all medical devices in India. Since the notification (Fts No. 29/MiscJO3/2020-DC (187)) dated 9.8.2021, intracorneal rings are explicitly classified as Class C devices, requiring stringent regulatory compliance.

Class C devices typically require a manufacturing license under MD9 and an import license under MD15 (if applicable), both granted by the Central Licensing Authority (CLA). These licenses ensure that the device meets all safety, efficacy, and quality standards before entering the Indian market.

Risk Classification and License Requirements for Intracorneal Rings

• Risk Class: C
• Regulatory License:
  • Manufacturing: MD9 license (Form MD7) issued by Central Licensing Authority
  • Import: MD15 license (Form MD14) issued by Central Licensing Authority

Class C classification reflects the moderate to high risk of implantable ophthalmic devices, necessitating comprehensive documentation, product testing, and audits to ensure patient safety.

Manufacturing License Process for Intracorneal Rings (MD9 License)

Manufacturers of intracorneal rings must apply for an MD9 license via the CDSCO MD Online Portal. The process comprises several steps:

1. Test License (Form MD13): Obtain a test license to manufacture and test product samples. This phase typically takes 1.5 to 2 months.

2. Product Testing: Conduct mandatory product testing at government-approved laboratories. Testing focuses on biocompatibility, mechanical integrity, and sterility, critical for implantables. Refer to the list of testing laboratories for approved facilities.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Submit the MD9 license application (Form MD7) through the CDSCO MD Online Portal.

5. Inspection and Audit: CDSCO inspectors conduct audits to verify compliance with Good Manufacturing Practices (GMP) and regulatory requirements.

6. Query Resolution: Address any queries raised by CDSCO during the review and audit process.

7. Grant of License: Upon successful compliance, the MD9 manufacturing license is granted on Form MD9.

Manufacturing License Documents Required for Intracorneal Rings

For Class C devices like intracorneal rings, the following documents are mandatory:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Tenancy of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed device specifications, design, manufacturing process, and validation (see our detailed Device Master File guide)
• Plant Master File (PMF): Information on manufacturing facility, equipment, and quality assurance processes (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with Indian medical device regulations
• Risk Management File detailing hazard analysis and mitigation strategies (Risk Management Guide)
• Test Reports from CDSCO-approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documentation (ISO 13485:2016 compliance)

Import License Process for Intracorneal Rings (MD15 License)

Importers of intracorneal rings must secure an MD15 license before marketing the product in India. The process includes:

1. Document Compilation: Collect all required documents including manufacturing license, Free Sale Certificate, ISO certificates, CE certificates, and Device and Plant Master Files.

2. Application Submission: File the MD15 license application (Form MD14) through the CDSCO MD Online Portal.

3. Review and Queries: CDSCO reviews the application and may raise queries.

4. Approval and License Grant: Once all conditions are satisfied, the MD15 import license is issued.

Note: Unlike manufacturing, no test license is required for import applications.

Import License Documents Required for Intracorneal Rings

• Valid Manufacturing License (MD9) from the country of origin
• Free Sale Certificate issued by the regulatory authority in the country of manufacture
• ISO 13485:2016 Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License or Distribution License
• Company Constitution and address proof

Timeline and Processing Duration

The MD9 license includes the initial test license phase (~1.5-2 months), product testing, audit, and final approval. Delays often arise due to incomplete documents or audit observations.

Government Fees and Costs

• MD9 Manufacturing License:

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

• MD15 Import License:

  • Fees vary by class; for Class C devices approximately ₹2,50,000 per site and ₹1,50,000 per product (converted from USD rates)

Additional costs include product testing charges at approved laboratories and audit fees payable to notified bodies.

Common Challenges and Solutions

Challenges:

• Incomplete or inaccurate documentation leading to prolonged queries
• Delays in product testing due to limited capacity at approved labs
• Audit non-conformities related to QMS and facility standards
• Misclassification of device risk leading to incorrect license applications

Practical Solutions:

• Engage experienced regulatory consultants early for document preparation
• Pre-validate testing requirements and book slots at notified labs well in advance
• Conduct internal audits to identify gaps prior to CDSCO inspections
• Use the Medical Device Classification tool to confirm device class
• Maintain transparent communication channels with CDSCO officials

Expert Consultation and Support

With over 25 years of regulatory consulting experience and a track record of supporting 500+ companies, we guide you through each step—from drafting your Device Master File to coordinating with notified bodies for audits. Our expertise ensures a smooth, compliant, and timely approval process for intracorneal ring devices.

Explore our detailed MD9 License Guide for further insights.

Getting Started with Your CDSCO License Application for Intracorneal Rings

1. Confirm Device Classification: Verify your intracorneal ring is classified as Class C.
2. Gather Required Documents: Collect all technical, legal, and quality documents.
3. Apply for Test License (MD13): Initiate manufacturing feasibility and testing.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs early.
5. Prepare for Audit: Align your facility and QMS with regulatory standards.
6. Submit Application via CDSCO MD Online Portal: Use this portal to efficiently manage submissions.

Starting early and following these steps minimizes delays and maximizes your chances of successful market entry. Should you require personalized assistance, our consultants are available to provide end-to-end support.

For direct application submissions, visit the CDSCO MD Online Portal.

By adhering to these guidelines and leveraging expert support, manufacturers and importers of intracorneal rings can confidently navigate the CDSCO licensing process and bring innovative ophthalmic solutions to patients across India.