CDSCO License for Ultrasound pachymeter

Comprehensive Guide to CDSCO Licensing for Ultrasound Pachymeter

As a specialized ophthalmic medical device, the Ultrasound Pachymeter plays a crucial role in measuring corneal thickness using ultrasound technology. It may also be designed to assess axial length and anterior chamber depth, making it essential in ophthalmic diagnostics and surgical planning. Navigating the Indian regulatory landscape for this device requires a thorough understanding of the Central Drugs Standard Control Organization (CDSCO) requirements, especially since it falls under Risk Class B.

With over 25 years of experience assisting more than 500 manufacturers and importers, we provide you with an expert roadmap to secure your CDSCO license efficiently and compliantly.

CDSCO Regulatory Framework for Ultrasound Pachymeter

The CDSCO governs medical device regulation in India under the Medical Devices Rules, 2017. The Ultrasound Pachymeter, categorized under ophthalmology and notified via Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, falls under Class B as per CDSCO’s risk classification system.

Manufacturers must comply with the relevant licensing, quality, safety, and performance standards before marketing this device in India. The licensing authority for Class B devices is the State Licensing Authority, and the manufacturing license is issued in the form of an MD5 License.

Risk Classification and License Requirements for Ultrasound Pachymeter

• Risk Class: B (Low to moderate risk)
• License Type: MD5 License (for manufacturing)
• Governing Authority: State Licensing Authority
• Application Form: MD3 for manufacturing license
• Notification Number: Fts No. 29/MiscJO3/2020-DC (187)

Because it is a Class B device, you will follow the MD5 licensing pathway, which involves a test license (MD13), product testing in CDSCO-recognized labs, and an audit by a notified body.

Manufacturing License Process (MD5) for Ultrasound Pachymeter

The manufacturing license process for a Class B device involves several key steps:

1. Apply for a Test License (Form MD13): This initial step allows you to manufacture the device for testing purposes. Expect a processing time of 1.5 to 2 months.
2. Product Testing: Conduct testing at government-approved laboratories to verify compliance with safety and performance standards. Refer to the CDSCO Testing Laboratories list to select an approved lab.
3. Document Preparation: Compile all required documents, including technical files, quality management system (QMS) documentation, and risk management files.
4. Apply for Manufacturing License (Form MD3): Submit the application through the CDSCO MD Online Portal.
5. Audit by Notified Body: The State Licensing Authority appoints a notified body to conduct a facility audit and review your compliance with regulatory requirements. You can check the list of notified bodies for audit assignments.
6. Query Resolution: Respond promptly to any queries raised by the department or notified body.
7. Grant of MD5 License: Upon satisfactory compliance, the license is issued on Form MD5.

Typically, the entire process takes approximately 3 to 4 months after test license issuance.

Manufacturing License Documents Required for Ultrasound Pachymeter

To ensure a smooth application, prepare the following documentation meticulously:

• Company Constitution and Incorporation Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience Certificates
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed design, specifications, and manufacturing processes. Our Device Master File guide provides comprehensive insights.
• Plant Master File (PMF): Information on your manufacturing facility. Refer to our Plant Master File guide.
• Essential Principles Checklist: Demonstrating compliance with Indian regulatory standards.
• Risk Management File: Documenting identified risks and mitigation strategies. Check our Risk Management resource.
• Test Reports: From CDSCO-recognized labs validating device safety and performance.
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documentation: Typically ISO 13485:2016 certification or equivalent.

Import License Process (MD15) for Ultrasound Pachymeter

If you plan to import the Ultrasound Pachymeter into India, you must obtain an MD15 Import License from the Central Licensing Authority.

The process includes:

• Document Preparation: Including your foreign manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.
• Application Submission: File Form MD14 on the CDSCO MD Online Portal.
• Query Resolution: Address any departmental queries promptly.
• License Grant: The MD15 license is issued upon satisfactory review.

Processing time ranges from 5 to 6 months.

Import License Documents Required for Ultrasound Pachymeter

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License in India
• Company Constitution

Timeline and Processing Duration

Government Fees and Costs

• MD5 Manufacturing License:
  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500
• Import License (MD15): Fees vary by risk class and site, for Class B devices:
  • Site Fee: $2,000
  • Per Product Fee: $1,000

These fees are payable online via the CDSCO portal.

Common Challenges and Solutions

• Delayed Test Report Approvals: To avoid bottlenecks, select CDSCO-approved testing laboratories with shorter turnaround times. Pre-book slots whenever possible.
• Incomplete Documentation: Maintain a detailed checklist to ensure submission completeness. Our Device Master File and Plant Master File guides can help you organize documentation efficiently.
• Audit Non-Compliance: Prepare your facility and QMS rigorously before the notified body audit. Conduct internal audits to preempt any non-conformities.
• Query Resolution Delays: Respond promptly and comprehensively to queries raised by CDSCO or notified bodies to prevent delays.

Expert Consultation and Support

With our extensive experience in medical device regulatory affairs, we assist manufacturers and importers through every stage of the CDSCO licensing process for ophthalmic devices such as the Ultrasound Pachymeter. Our services include:

• Regulatory strategy and classification advice
• Comprehensive documentation preparation
• Coordination with notified bodies and testing labs
• Audit readiness and QMS consultancy
• Application filing and follow-up

Getting Started with Your CDSCO License Application for Ultrasound Pachymeter

1. Assess Your Device Classification: Confirm your device’s Class B status as per the Medical Device Classification guidelines.
2. Develop Technical Documentation: Begin compiling your Device Master File and Plant Master File.
3. Apply for Test License (MD13): Submit your initial test license application through the CDSCO MD Online Portal.
4. Schedule Product Testing: Engage a CDSCO-approved laboratory early to align testing timelines.
5. Prepare for Audit: Ensure all regulatory and QMS requirements are met in advance.
6. Submit Manufacturing License Application (Form MD3): Once test reports are ready, file the manufacturing license application online.

By following these actionable steps and leveraging expert support, you can significantly reduce time-to-market and ensure compliance for your Ultrasound Pachymeter in India.

For personalized assistance and to streamline your CDSCO licensing journey, contact our regulatory consulting team today.