CDSCO License for Operator radiation protection spectacles

Comprehensive Guide to CDSCO License for Operator Radiation Protection Spectacles (Class B Medical Device)

Operator radiation protection spectacles are vital personal protective equipment designed to shield operators and other personnel from harmful exposure to primary and scattered radiation during radiotherapy and diagnostic procedures. Given the potential risks associated with radiation, these devices fall under Class B medical devices as per CDSCO’s classification, necessitating a structured regulatory approval process to ensure safety and efficacy before market entry in India.

With over 25 years of experience assisting more than 500 manufacturers and importers, we provide an authoritative walkthrough of the CDSCO licensing process specific to operator radiation protection spectacles.

CDSCO Regulatory Framework for Operator Radiation Protection Spectacles

The Central Drugs Standard Control Organisation (CDSCO) governs the regulation of medical devices in India, including radiation protection spectacles categorized under radiotherapy devices. The regulatory framework mandates compliance with the Medical Device Rules, 2017, and related notifications such as File No. 29/Misc./03/2020-DC (180), dated 6.8.2021, which specifically addresses the classification and regulatory requirements of such devices.

The key regulatory pathway for manufacturers of Class B devices like radiation protection spectacles involves obtaining an MD5 manufacturing license from the respective State Licensing Authority.

Risk Classification and License Requirements

• Device: Operator radiation protection spectacles
• Risk Class: B (Low-moderate risk)
• Regulatory License: MD5 Manufacturing License (Form MD3 application)
• Authority: State Licensing Authority

Class B devices require a thorough but streamlined regulatory approach involving compliance with essential principles, product testing, and quality management system adherence.

Manufacturing License Process (MD5)

The MD5 license process for Class B devices consists of the following key steps:

1. Test License Application (Form MD13): Initiate by applying for a Test License, valid for 2 years, allowing product testing in government-approved laboratories.
2. Product Testing: Submit radiation protection spectacles samples to CDSCO notified testing laboratories for performance and safety evaluation.
3. Document Preparation: Compile required technical and compliance documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
4. Submission of MD5 Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Undergo a mandatory audit by a CDSCO recognized notified body listed here.
6. Respond to Queries: Address any observations or document clarifications sought by the licensing authority or notified body.
7. Grant of MD5 License: Upon successful compliance, the State Licensing Authority issues the MD5 license permitting manufacturing.

For detailed guidance, our MD5 license guide provides step-by-step instructions.

Manufacturing License Documents Required

Successful licensing depends on comprehensive documentation. For operator radiation protection spectacles, prepare the following:

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF) detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) covering manufacturing environment and quality control (Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance standards
• Risk Management File compliant with ISO 14971 (Risk Management Guide)
• Test Reports from CDSCO approved laboratories (Testing Laboratories List)
• Product Labels and Instructions for Use (IFU)
• Quality Management System Documents demonstrating compliance with ISO 13485:2016

Import License Process (MD15)

For importers of operator radiation protection spectacles, the MD15 license issued by the Central Licensing Authority is mandatory. The process includes:

• Comprehensive document preparation, including:
  • Manufacturing License of the foreign manufacturer
  • Free Sale Certificate
  • ISO 13485:2016 certificate
  • CE Certificate (if applicable)
  • Device and Plant Master Files
  • Wholesale License
  • Company Constitution
• Application submission on the CDSCO MD Online Portal
• Departmental review and query resolution
• License grant on Form MD15

Typical timelines for import licenses range between 5-6 months, with fees structured as per device class.

Our detailed Import License Guide offers further insights.

Import License Documents Required

For operator radiation protection spectacles import license (MD15), prepare:

• Valid Manufacturing License from country of origin
• Free Sale Certificate from the regulator of the manufacturing country
• Quality Management System certificates (ISO 13485:2016)
• CE Mark Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license for distribution in India
• Company Constitution and legal documentation

Timeline and Processing Duration

Planning ahead and preparing documents meticulously can reduce delays. For imports, expect 5 to 6 months.

Government Fees and Costs

• MD5 Manufacturing License:

  • Application Fee: ₹5,000 per application
  • Product Fee: ₹500 per product

• Test License (MD13): Included in MD5 process; no separate fee specified

• Import License (MD15):

  • Class B Devices: ₹2,000 per site + ₹1,000 per product

Additional costs may include testing fees charged by notified laboratories and audit fees payable to notified bodies.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants face rejection due to missing or inconsistent documents. We recommend using comprehensive checklists and templates to ensure completeness.
• Delayed Product Testing: Testing labs can have backlogs; early submission and coordination reduce wait times.
• Audit Non-Compliance: Pre-audit readiness assessments and mock audits can help identify gaps before official inspections.
• Regulatory Updates: Stay informed on notifications like File No. 29/Misc./03/2020-DC (180) to avoid outdated practices.

Expert Consultation and Support

Navigating the CDSCO regulatory landscape for radiation protection spectacles can be complex. Our expert consultants bring decades of hands-on experience, having supported over 500 successful licensing projects. We assist with:

• Accurate risk classification and applicability analysis
• Document preparation and review
• Liaison with testing laboratories and notified bodies
• Audit readiness and compliance
• Query resolution and follow-up with CDSCO authorities

Getting Started with Your CDSCO License Application

1. Assess your device classification and licensing pathway based on CDSCO guidelines.
2. Register and submit your initial Test License (Form MD13) application through the CDSCO MD Online Portal.
3. Engage a CDSCO notified laboratory early to schedule product testing.
4. Begin compiling the Device Master File and Plant Master File using standardized templates.
5. Prepare your Quality Management System documents, including risk management files.
6. Identify a notified body from the official list for your mandatory audit.
7. Once testing and documentation are ready, submit your MD5 application (Form MD3) online.
8. Prepare for and facilitate the audit process, promptly addressing any queries.

By following these focused steps and leveraging professional regulatory support, manufacturers and importers of operator radiation protection spectacles can efficiently secure their CDSCO licenses and confidently enter the Indian market.

For personalized assistance, reach out to our regulatory experts who specialize in medical device compliance and licensing.