CDSCO License for Corneal shield

Introduction to Corneal Shield and Regulatory Importance

The Corneal Shield, a Class B medical device in the ophthalmology category, is designed as a mechanical eye shield made of collagen to protect the cornea. Given its direct interaction with the delicate eye surface, regulatory compliance is paramount to ensure patient safety and product efficacy. The Central Drugs Standard Control Organization (CDSCO) governs the licensing process for such devices in India. Successfully navigating this regulatory framework is essential for manufacturers and importers aiming to enter the Indian market.

With over 25 years of experience and having supported 500+ companies, we understand the nuances involved in CDSCO licensing for ophthalmic devices like the Corneal Shield. This guide provides detailed, actionable insights to streamline your licensing journey.

CDSCO Regulatory Framework for Corneal Shield (Class B Device)

The Corneal Shield falls under Class B, which denotes a low-moderate risk device according to the CDSCO medical device classification. The regulatory oversight is conducted primarily at the state level, requiring an MD5 manufacturing license. For importers, the MD15 import license from the central authority is applicable.

Since the Corneal Shield is notified under the Gazette Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, it mandates adherence to the guidelines outlined by CDSCO for ophthalmic medical devices.

Risk Classification and License Requirements

• Device Risk Class: Class B (Low to moderate risk)
• Applicable License for Manufacturing: MD5 License (Form MD3)
• Issued By: State Licensing Authority
• Applicable License for Import: MD15 License (Form MD14)
• Testing Requirements: Mandatory product testing from CDSCO-approved laboratories

For detailed device classification framework, you can refer to the Medical Device Classification guide.

Manufacturing License Process for Corneal Shield (MD5 License)

Obtaining an MD5 manufacturing license involves the following key steps:

1. Test License Application (Form MD13): Apply for a test license to initiate product testing. This license is valid for up to 2 years and facilitates initial market trials.

2. Product Testing: Conduct mandatory testing at CDSCO-recognized laboratories to validate safety and performance. Visit the list of testing laboratories for approved labs.

3. Documentation Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. License Application (Form MD3): Submit the MD5 license application through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will perform a facility audit to verify compliance. You can check the list of notified bodies authorized for audits.

6. Query Resolution: Address any queries raised during audit or by CDSCO officials promptly to avoid delays.

7. Grant of License (Form MD5): Upon successful evaluation, the manufacturing license is issued.

For an in-depth walkthrough, our MD5 License Guide provides essential details.

Manufacturing License Documents Required

When applying for the MD5 license for the Corneal Shield, ensure you have the following documents:

• Company Constitution (Incorporation Certificate, Memorandum and Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire Safety NOC
• Pollution Control Board Clearance
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF) describing manufacturing facility and equipment. Refer to our Plant Master File Guide
• Essential Principles Checklist confirming compliance with Indian medical device regulations
• Risk Management File demonstrating identified hazards and mitigation strategies. Learn more about Risk Management
• Product Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification is highly recommended)

Import License Process for Corneal Shield (MD15 License)

Importers intending to bring the Corneal Shield into India must apply for the MD15 import license through the CDSCO Central Licensing Authority. The process involves:

1. Document Preparation: Compile necessary documents including Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, Wholesale License, and Company Constitution.

2. Application Submission: Submit the application for MD15 license on the CDSCO MD Online Portal.

3. Departmental Review: The CDSCO will review documentation and may seek clarifications.

4. License Grant: Upon satisfactory review, the MD15 license is issued.

For detailed guidance, please consult our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License valid in India
• Company Constitution Documents
• Application Form MD14 duly filled

Timeline and Processing Duration

• MD5 Manufacturing License: Approximately 3 to 4 months

  • Test License (MD13): 1.5 to 2 months
  • Product Testing: 1 month (may vary depending on lab workload)
  • Application Review and Audit: 1 to 1.5 months

• MD15 Import License: Approximately 5 to 6 months

Timelines may fluctuate based on application completeness and query resolution speed.

Government Fees and Costs

• MD5 Manufacturing License Fees:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• MD15 Import License Fees:

  • For Class B Devices: Rs. 2000 per site
  • Rs. 1000 per product

Note: Fees are payable online via the CDSCO MD Online Portal during application submission.

Common Challenges and Solutions

• Incomplete Documentation: Missing or inconsistent documents cause delays. Solution: Use our comprehensive checklists and professional consultation to prepare error-free dossiers.

• Delayed Product Testing: Limited slots at government-approved labs can extend timelines. Solution: Plan testing well in advance and consider multiple labs from the approved testing laboratories list.

• Audit Non-compliance: Failing audits due to facility or quality system gaps. Solution: Conduct internal pre-audit assessments and engage notified bodies early.

• Query Resolution Delays: Slow response to CDSCO queries stalls approval. Solution: Assign dedicated regulatory personnel to handle communications promptly.

Expert Consultation and Support

Navigating CDSCO licensing for the Corneal Shield demands in-depth knowledge of regulatory nuances and procedural rigor. Our experienced team offers tailored consulting services, including dossier preparation, audit readiness, and liaison with CDSCO authorities. With a track record of 500+ successful licenses, we ensure your application is robust and compliant.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm Corneal Shield’s Class B status.
2. Prepare Documentation: Utilize our detailed guides on Device Master File, Plant Master File, and Risk Management.
3. Apply for Test License (MD13): Submit application via the CDSCO MD Online Portal.
4. Coordinate Product Testing: Book slots with CDSCO-approved labs early.
5. Compile Complete Application (MD3): Once testing is complete, prepare the MD5 license application.
6. Schedule Audit: Engage a notified body for facility audit.
7. Submit and Follow Up: Monitor application progress and respond promptly to queries.

For a seamless journey, consider partnering with regulatory experts to avoid common pitfalls and accelerate market entry for your Corneal Shield.

Embark on your CDSCO licensing process today with confidence and clarity!