CDSCO License for Glaucoma therapy ultrasound system

Comprehensive Guide to CDSCO Licensing for Glaucoma Therapy Ultrasound Systems (Class C)

As specialists with over 25 years of experience in Indian medical device regulatory affairs, we understand the complexities manufacturers and importers face while obtaining CDSCO licenses. The Glaucoma Therapy Ultrasound System, categorized under ophthalmology and classified as a Class C device, requires meticulous compliance with CDSCO regulations to legally manufacture or import in India.

Understanding the Device and Regulatory Importance

This system transduces radio-frequency (RF) electrical energy into ultrasound energy, applying high-intensity focused ultrasound (HIFU) extracorporeally to reduce intraocular pressure (IOP) by decreasing aqueous humour production. Due to its critical therapeutic application and moderate risk profile, it falls under Class C as per the CDSCO classification notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

CDSCO Regulatory Framework for Glaucoma Therapy Ultrasound Systems

India’s Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices. Devices classified as Class C require a manufacturing license under MD9, issued by the Central Licensing Authority. For imports, an MD15 import license is mandatory.

Risk Classification and License Requirements for Your Device

• Device Risk Class: Class C (Moderate to High Risk)
• Manufacturing License: MD9 License (Application Form MD7)
• Import License: MD15 License (Application Form MD14)

You can verify your device classification on our detailed Medical Device Classification guide.

Manufacturing License Process for Class C Devices (MD9 License)

Obtaining an MD9 license involves these critical steps:

1. Test License (Form MD13): Initial approval to begin testing, valid for 1.5-2 months.
2. Product Testing: Conducted at CDSCO-approved government laboratories to validate compliance.
3. Document Preparation: Compilation of technical, quality, and regulatory documents.
4. Application Submission: File the application on the CDSCO MD Online Portal using Form MD7.
5. CDSCO Audit: Inspection by CDSCO officials to verify manufacturing site and QMS.
6. Query Resolution: Address any observations or deficiencies raised by CDSCO.
7. License Grant: Issuance of MD9 manufacturing license upon satisfactory compliance.

Detailed Documents Required for MD9 Manufacturing License

• Company Constitution: Incorporation certificate, MOA, AOA
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualification Documents: CVs, certificates of competent personnel
• Fire No Objection Certificate (NOC)
• Pollution Control Board Clearance
• Device Master File (DMF): Detailed device specifications, design, manufacturing processes. Our Device Master File guide explains how to prepare this effectively.
• Plant Master File (PMF): Details of manufacturing facilities and quality systems. Refer to our Plant Master File Guide.
• Essential Principles Checklist: Compliance with Indian regulatory essentials
• Risk Management File: Comprehensive risk analysis and mitigation strategies complying with ISO 14971. Learn more at our Risk Management resource.
• Test Reports: From CDSCO-approved labs confirming device safety and efficacy
• Labels and Instructions for Use (IFU): Sample labels and user manuals
• Quality Management System (QMS) Documents: ISO 13485:2016 certifications, SOPs, CAPA records

Import License Process for Glaucoma Therapy Ultrasound Systems (MD15 License)

For importers, the MD15 license issued by CDSCO’s central office is mandatory. The process includes:

1. Document Preparation: Collect all required documents, including manufacturing license from the country of origin and quality certifications.
2. Application Submission: Apply online through the CDSCO MD Online Portal using Form MD14.
3. Query Handling: Promptly respond to any additional information requests.
4. License Issuance: Upon approval, the MD15 import license is granted.

Documents Required for MD15 Import License

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution documents

Timeline and Processing Duration

Government Fees and Costs

• MD9 Manufacturing License:
  • Application fee: Rs 50,000
  • Per product fee: Rs 1,000
• MD15 Import License:
  • Class C & D devices: Rs 3,000 per site
  • Rs 1,500 per product

Please note these fees are payable online via the CDSCO portal during application submission.

Common Challenges and Practical Solutions

• Delayed Test Reports: Government labs can have backlogs; proactively schedule testing and consider alternative approved testing laboratories to expedite.
• Incomplete Documentation: Missing or inconsistent data in DMF or PMF often leads to audit queries. Use detailed checklists and experienced consultants to prepare documents.
• Audit Non-Compliance: Unpreparedness during CDSCO inspections can cause delays. Conduct internal mock audits and train your technical staff.
• Query Resolution Delays: Timely and precise responses to CDSCO queries are critical. Maintain a dedicated regulatory point of contact.

Expert Consultation and Support

With over 500 successful CDSCO license approvals for Class C devices like glaucoma therapy systems, our regulatory consulting team offers:

• End-to-end application preparation
• Gap analysis of your technical files
• Liaison with CDSCO and notified bodies
• Training for your quality and regulatory teams

We also recommend checking the list of notified bodies for your audit requirements.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm Class C status using CDSCO notifications and classification resources.
2. Prepare Your Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to initiate testing.
3. Engage Accredited Testing Labs: Schedule product testing early to stay within timelines.
4. Compile Comprehensive Documentation: Utilize our guides for DMF and PMF to ensure completeness.
5. Submit MD9 Manufacturing License Application: Once test results are obtained, apply using Form MD7.
6. Prepare for CDSCO Audit: Conduct internal audits and address potential non-conformities.
7. Resolve Queries Promptly: Maintain communication channels open with CDSCO.

By following these actionable steps and leveraging expert guidance, manufacturers and importers can successfully navigate the CDSCO licensing pathway for glaucoma therapy ultrasound systems, gaining timely market entry in India’s demanding regulatory environment.

For personalized assistance, reach out to our regulatory consulting team who have propelled 500+ companies to CDSCO license approvals with efficient, compliant strategies tailored for ophthalmic Class C devices.