CDSCO License for Retinal tack

Comprehensive Guide to CDSCO Licensing for Retinal Tack (Class C Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies, we understand the unique nuances involved in obtaining CDSCO licenses for specialized ophthalmic devices like the Retinal Tack. This implantable, non-bioabsorbable device is designed to permanently fix a detached retina to the retinal pigment epithelium during surgery, placing it firmly in the Class C risk category under Indian regulations. Securing the appropriate CDSCO license is critical for legally manufacturing or importing the Retinal Tack in India and ensuring patient safety.

Understanding the CDSCO Regulatory Framework for Retinal Tack

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. The Retinal Tack falls under the ophthalmology category and is classified as a Class C device based on its invasive nature and potential risk profile. This classification dictates the licensing path and compliance obligations.

Risk Classification and License Requirements for Retinal Tack

According to the Medical Device Classification, the Retinal Tack is a Class C device due to its implantable nature and critical function in ocular surgery. Manufacturers must obtain the MD9 manufacturing license, granted by the Central Licensing Authority, to legally produce this device in India. Importers require the MD15 import license.

MD9 Manufacturing License Process for Retinal Tack

Obtaining an MD9 license involves several key steps:

1. Test License Application (Form MD13): Initially, the manufacturer must apply for a Test License on Form MD13 via the CDSCO MD Online Portal. This takes approximately 1.5 to 2 months and allows product testing.

2. Product Testing: The Retinal Tack must undergo mandatory testing at CDSCO-approved laboratories. Refer to the Testing Laboratories list for authorized facilities. Test reports are essential for the license application.

3. Documentation Preparation: Prepare comprehensive documentation including the Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documentation, tailored specifically for the Retinal Tack.

4. License Application (Form MD7): Submit the MD9 application on the CDSCO portal, attaching all required documents.

5. Inspection and Audit: CDSCO inspectors will conduct a thorough audit of the manufacturing premises and quality systems.

6. Queries and Clarifications: Respond promptly to any queries raised by CDSCO or audit teams.

7. Grant of License (Form MD9): Upon satisfactory review, the license is granted.

Essential Documents Required for MD9 License

For a Class C device such as the Retinal Tack, the following documents are mandatory:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Detailed Device Master File (DMF) — see our Device Master File guide
• Plant Master File (PMF) — refer to our Plant Master File guide
• Essential Principles Checklist showing compliance with Indian regulations
• Risk Management File documenting hazard analysis and mitigation per Risk Management standards
• Product Test Reports from CDSCO-approved labs
• Product Label and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, typically ISO 13485:2016 certification

Import License Process for Retinal Tack (MD15)

Importers of the Retinal Tack must apply for the MD15 license. The process is as follows:

• Prepare all relevant documents including the manufacturer’s MD9 or equivalent license, Free Sale Certificate from the country of origin, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, wholesale license, and company incorporation documents.

• Apply on Form MD14 via the CDSCO MD Online Portal.

• The process typically takes 5 to 6 months, including document scrutiny and query resolution.

Timeline and Processing Duration

Manufacturers should factor in these timelines for effective market entry planning.

Government Fees and Costs

For the Retinal Tack as a Class C device:

• MD9 License Fees:

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

• MD15 Import License Fees:

  • Site Fee: $3,000 (approx. ₹2,40,000)
  • Per Product Fee: $1,500 (approx. ₹1,20,000)

Additional costs include product testing, notified body audits, and documentation preparation.

Common Challenges and Practical Solutions

Challenge: Delays due to incomplete documentation or inadequate test reports.

Solution: Engage experienced consultants to prepare and review documentation meticulously and select accredited testing laboratories early.

Challenge: Audit non-compliance or facility readiness issues.

Solution: Conduct pre-audit internal assessments and implement corrective actions proactively.

Challenge: Navigating complex query responses from CDSCO inspectors.

Solution: Maintain clear records and submit detailed, timely responses with technical justifications.

Expert Consultation and Support

Our team has guided over 500 medical device companies through the CDSCO licensing journey, specializing in ophthalmic and implantable devices like the Retinal Tack. We offer end-to-end support—from initial classification and documentation to audit readiness and post-approval compliance.

Getting Started with Your CDSCO License Application

Manufacturers and importers aiming to enter the Indian market with the Retinal Tack should take the following practical steps:

1. Self-Assessment: Confirm your device classification as Class C using the Medical Device Classification tool.

2. Documentation Preparation: Begin compiling the Device Master File and Plant Master File following regulatory guidelines.

3. Test License Application: Submit your Form MD13 application on the CDSCO MD Online Portal.

4. Select Testing Laboratory: Choose a CDSCO-approved testing lab from the official list to initiate product testing.

5. Engage Notified Bodies: Identify and liaise with notified bodies for audit requirements; see the list of notified bodies.

6. Plan for Audit and Inspection: Prepare your facility and QMS for the upcoming CDSCO audit.

7. Submit License Application: After obtaining test reports and completing documentation, apply for the MD9 license via the portal.

By following these steps and leveraging expert assistance, manufacturers and importers can navigate the CDSCO licensing process efficiently and compliantly, accelerating the availability of the Retinal Tack to Indian patients.

For personalized assistance tailored to your Retinal Tack licensing needs, contact our regulatory experts today and benefit from our proven track record in CDSCO approvals.