CDSCO License for Ophthalmic ultrasound imaging system

Comprehensive Guide to CDSCO Licensing for Ophthalmic Ultrasound Imaging Systems (Class B)

As a leading regulatory consultancy with over 25 years of experience and more than 500 successful CDSCO license approvals, we understand the critical importance of compliance for medical devices like the Ophthalmic Ultrasound Imaging System. This device, classified as Class B under the CDSCO framework, plays a vital role in ophthalmology by enabling precise ultrasound imaging for diagnostic purposes. Ensuring timely and accurate regulatory approval is essential to bring this advanced technology to the Indian healthcare ecosystem safely and efficiently.

CDSCO Regulatory Framework for Ophthalmic Ultrasound Imaging Systems

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Since the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, ophthalmic ultrasound imaging systems have been explicitly regulated under the Medical Device Rules, 2017, and subsequent amendments.

Our deep expertise in navigating CDSCO’s regulatory landscape ensures manufacturers and importers can confidently meet all compliance requirements. The device falls within Class B, indicating a moderate risk level, necessitating adherence to specific licensing procedures to guarantee safety, efficacy, and quality.

Risk Classification and License Requirements for Class B Medical Devices

Ophthalmic ultrasound imaging systems are categorized as Class B devices, which require a manufacturing license under Form MD3 (MD5 license) issued by the State Licensing Authority. Importers must apply for an import license (Form MD14 for MD15 license) granted by the Central Licensing Authority.

Class B devices demand rigorous documentation, product testing, and audits but benefit from relatively shorter processing times compared to higher-risk classes.

Manufacturing License Process (MD5) for Ophthalmic Ultrasound Imaging Systems

The MD5 license process involves several critical steps:

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

2. Product Testing: Submit samples to government-approved testing laboratories. Testing duration varies but generally requires 3-4 weeks. Refer to the Testing Laboratories list for authorized facilities.

3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. License Application Submission: File the manufacturing license application on Form MD3 via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body audits the manufacturing premises and QMS. Check the list of notified bodies to select an accredited auditor.

6. Queries Resolution: Address any queries raised during document review or audit.

7. Grant of License: Upon successful completion, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required for Ophthalmic Ultrasound Imaging Systems

• Company Constitution Documents
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing device design and specifications. For guidance, see our Device Master File guide.
• Plant Master File (PMF) describing manufacturing processes. Learn how to prepare one in our Plant Master File guide.
• Essential Principles Checklist confirming compliance with regulatory standards
• Risk Management File demonstrating identification and mitigation of risks. More on risk management.
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System Documents (ISO 13485:2016 certification is highly recommended)

Import License Process (MD15) for Ophthalmic Ultrasound Imaging Systems

For importers, the MD15 license is mandatory and administered by the Central Licensing Authority. The process includes:

1. Document Preparation: Assemble all required documents, including manufacturing license from the country of origin.

2. Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.

3. Queries Resolution: Respond to any clarifications raised by CDSCO.

4. Grant of Import License: Once approved, the MD15 license is issued.

Notably, unlike manufacturing licenses, no test license is required for import.

Import License Documents Required

• Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

The test license phase alone takes approximately 1.5 to 2 months, followed by product testing and audit. Efficient preparation and proactive query handling can significantly reduce delays.

Government Fees and Costs

For Class B ophthalmic ultrasound imaging systems:

• MD5 Manufacturing License:

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

• MD15 Import License:

  • Site Fee: $2,000
  • Per Product Fee: $1,000

Additional costs include audit fees charged by notified bodies and expenses for testing at accredited laboratories.

Common Challenges and Practical Solutions

• Delayed Test Reports: Partner with CDSCO-approved laboratories early to schedule timely testing.

• Incomplete Documentation: Use comprehensive checklists and templates to ensure all documents, such as the Device Master File and Risk Management File, meet regulatory standards.

• Audit Non-compliance: Conduct internal audits and gap assessments before the notified body audit to avoid surprises.

• Query Resolution Delays: Assign dedicated regulatory personnel to promptly address CDSCO queries.

Our experience has repeatedly shown that meticulous preparation and proactive communication are the keys to overcoming these hurdles.

Expert Consultation and Support

With over 500 successful CDSCO license applications for medical devices like ophthalmic ultrasound imaging systems, our consultancy offers tailored support:

• Document preparation and review
• Scheduling and coordination of product testing
• Liaising with notified bodies
• Audit readiness and mock inspections
• Query handling and follow-ups

Engage our experts early in your product lifecycle to streamline your regulatory strategy and expedite market entry.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm your device's Class B status by referring to the Medical Device Classification guidelines.

2. Prepare Essential Documentation: Begin compiling the Device Master File, Plant Master File, and Risk Management File.

3. Apply for Test License (Form MD13): Submit your application through the CDSCO MD Online Portal to initiate manufacturing sample testing.

4. Plan Product Testing: Schedule tests at government-approved labs to avoid delays.

5. Engage Notified Body Early: Identify and communicate with a suitable auditor from the Notified Bodies list.

6. Prepare for Audit: Conduct internal audits and rectify issues before official inspection.

7. Submit Manufacturing License Application (Form MD3): After successful test results and audit, apply for the MD5 license.

By following these actionable steps and leveraging our deep regulatory expertise, manufacturers and importers of ophthalmic ultrasound imaging systems can confidently navigate the CDSCO licensing process and achieve timely market access in India.