CDSCO License for Keratome

Comprehensive Guide to CDSCO Licensing for Keratome – Ophthalmic Surgical Instrument (Class B)

Keratome, a specialized ophthalmic surgical instrument used to precisely shave corneal tissue for lamellar transplants, plays a critical role in eye surgeries. Given its invasive nature and patient safety implications, obtaining a valid CDSCO license is mandatory for manufacturing or importing this Class B medical device in India. With over 25 years of regulatory consulting experience and successful licensing of 500+ medical devices, we provide a detailed roadmap tailored for Keratome manufacturers and importers to streamline compliance with CDSCO regulations.

CDSCO Regulatory Framework for Ophthalmic Devices like Keratome

The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, governs the regulation of medical devices in India. Following the Medical Device Rules (MDR) 2017, devices are categorized into risk classes A, B, C, and D based on potential patient risk. Keratome falls under Class B due to its moderate risk profile, requiring compliance with specific licensing, quality management, and safety standards.

Risk Classification and License Requirements for Keratome

• Device Name: Keratome
• Risk Class: B (Moderate risk)
• Category: Ophthalmology
• Intended Use: Surgical instrument for corneal tissue shaving
• Notification: Fts No. 29/MiscJO3/2020-DC (187)
• Notification Date: 09.08.2021

Class B devices like Keratome require an MD5 manufacturing license, issued by the State Licensing Authority. The process involves obtaining a test license (MD13), product testing at CDSCO-approved labs, audit by notified bodies, and submission of comprehensive documentation.

For importers, an MD15 import license from the Central Licensing Authority is mandatory before marketing the device in India.

Manufacturing License Process for Keratome (MD5 License)

Step 1: Obtain Test License (Form MD13)

Manufacturers first apply for a test license through the CDSCO MD Online Portal. This license permits product testing and quality evaluation and typically takes 1.5 to 2 months to be granted.

Step 2: Product Testing

The Keratome must undergo rigorous testing at government-approved laboratories to validate compliance with Indian standards. You can find an updated list of Testing Laboratories authorized by CDSCO.

Step 3: Document Preparation

Prepare detailed submissions including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, Quality Management System (QMS) documents, and technical dossiers.

Step 4: Application Submission (Form MD3)

Submit the manufacturing license application electronically via the CDSCO MD Online Portal. The State Licensing Authority reviews the application.

Step 5: Audit by Notified Body

A mandatory audit is conducted by a notified body, selected from the list of notified bodies, to verify compliance with MDR and QMS requirements.

Step 6: Resolution of Queries

Respond promptly to any queries or observations raised by the licensing authority or notified body to avoid delays.

Step 7: Grant of License (Form MD5)

Upon satisfactory review and audit, the MD5 manufacturing license is granted.

Manufacturing License Documents Required for Keratome

• Company Constitution and Incorporation Certificates
• Proof of Ownership/Lease of Manufacturing Premises
• Detailed Device Master File (DMF) – Refer to our Device Master File Guide
• Plant Master File (PMF) showcasing manufacturing site details – Learn more at Plant Master File Guide
• Essential Principles Checklist covering device safety and performance
• Risk Management File detailing hazard analysis and mitigation – See Risk Management Practices
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Proof of Technical Staff Qualifications
• Fire NOC and Pollution Control Board NOC
• Quality Management System Documents (ISO 13485 certification recommended)

Import License Process for Keratome (MD15 License)

Importers of Keratome must obtain an MD15 license from the Central Licensing Authority, which involves:

• Compiling documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and wholesale license.
• Submitting the application on the CDSCO MD Online Portal.
• Responding to departmental queries during the evaluation.

No test license is required for import licenses.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or Equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and Address Proof
• Detailed Product Information and Labeling

Timeline and Processing Duration

Manufacturers should anticipate approximately 3 to 4 months total for MD5 license processing, including all audits and testing. Importers should plan for 5 to 6 months for MD15 license issuance.

Government Fees and Costs

• MD5 License (Class B): Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License:
  • Class B: Approximately $2000 per site +$1000 per product

Additional costs include notified body audit fees, laboratory testing charges, and document preparation expenses.

Common Challenges and Solutions

• Delayed Test Reports: Partner with CDSCO-approved labs early; monitor timelines closely.
• Incomplete Documentation: Utilize checklists; engage expert consultants for DMF and PMF preparation.
• Non-Compliance in Audits: Conduct pre-audit internal reviews; train staff thoroughly.
• Query Management Delays: Respond promptly with detailed clarifications to CDSCO queries.

Expert Consultation and Support

Navigating the CDSCO licensing process for Keratome requires specialized expertise. Our team has facilitated over 500 successful license approvals by providing end-to-end support—from document drafting to audit readiness and query resolution. We recommend leveraging professional consultants to avoid costly delays and rejections.

Getting Started with Your CDSCO License Application for Keratome

1. Assess Your Device Classification: Confirm Keratome’s Class B status and applicable notifications.
2. Plan Document Preparation: Begin compiling your Device and Plant Master Files, essential principles checklist, and risk management documentation.
3. Apply for Test License (MD13): Submit your application early through the CDSCO MD Online Portal.
4. Engage Approved Testing Labs: Schedule product testing promptly to align with license timelines.
5. Select a Notified Body: Refer to the official list of notified bodies for scheduling your audit.
6. Prepare for Audit: Conduct internal audits and training to ensure compliance.
7. Submit Manufacturing License Application (MD3): Complete application with all required documents.
8. Respond to CDSCO Queries: Maintain open communication and provide thorough responses.

By following these actionable steps, manufacturers and importers of Keratome can efficiently navigate India’s regulatory landscape and bring this vital ophthalmic device to market with confidence.

For personalized consultancy and support tailored to your Keratome licensing needs, contact our expert team today.