CDSCO License for Radiation face protector

Understanding Radiation Face Protector and Its Regulatory Importance

Radiation face protectors are vital personal protective equipment designed to shield medical and allied personnel from both primary and scattered radiation during diagnostic and therapeutic procedures. Given the safety-critical nature of these devices, regulatory compliance is paramount to ensure efficacy and user safety. In India, the Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of such medical devices, ensuring they meet stringent quality standards before market entry.

With over 25 years of experience assisting more than 500 manufacturers and importers, we provide comprehensive support for obtaining CDSCO licenses for radiation face protectors, classified as Class A devices under the personal protective equipment category.

CDSCO Regulatory Framework for Radiation Face Protectors

Under the Medical Device Rules (MDR) 2017, radiation face protectors fall under Class A, the lowest risk category. The regulatory framework mandates manufacturers to obtain a manufacturing license (MD5) issued by the State Licensing Authority to legally produce and market these devices in India. Importers require an import license (MD15) granted by the Central Licensing Authority.

The relevant notification governing radiation face protectors is File No. 29/Misc./03/2020-DC (186), dated 13.9.2021, which officially classifies this device and dictates regulatory obligations.

Risk Classification and License Requirements for Radiation Face Protector

As a Class A medical device, radiation face protectors require an MD5 manufacturing license using Application Form MD3, which falls under the jurisdiction of the State Licensing Authority. This classification implies a relatively straightforward approval process compared to higher risk devices but still demands rigorous adherence to documentation and testing protocols.

Manufacturers must also secure a Test License (Form MD13) before proceeding with product testing in notified laboratories. The entire licensing workflow includes document submission, laboratory testing, notified body audit, and department review.

Manufacturing License Process (MD5) for Radiation Face Protectors

The MD5 license process is a multi-step journey that typically spans 3 to 4 months:

1. Test License (Form MD13): Apply via the CDSCO MD Online Portal to obtain a test license, enabling testing of radiation face protectors in government-approved labs. This step takes approximately 1.5 to 2 months.

2. Product Testing: Conduct mandatory testing at recognized laboratories listed on the Testing Laboratories page. Testing validates compliance with essential performance and safety standards.

3. Document Preparation: Compile essential documentation including Device Master File, Plant Master File, Risk Management File, and others outlined below.

4. License Application Submission (Form MD3): Submit the manufacturing license application on the CDSCO portal.

5. Audit by Notified Body: An audit by an authorized notified body, whose list can be found here, verifies compliance with quality systems and manufacturing practices.

6. Query Resolution: Address any queries raised during the audit or by CDSCO officials promptly.

7. License Grant (Form MD5): Upon successful review, the license is granted, authorizing manufacturing.

Manufacturing License Documents Required for Radiation Face Protectors

To streamline your application, ensure the following documents are complete and well-organized:

• Company Constitution Documents (e.g., Incorporation Certificate, Partnership Deed)
• Proof of Premises Ownership or Lease Agreement
• Technical Staff Qualification and Experience Certificates
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File: Detailed design and manufacturing information (Device Master File Guide)
• Plant Master File: Facility details and quality management systems (Plant Master File Guide)
• Essential Principles Checklist: Compliance with MDR essential principles
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management)
• Test Reports from Government Approved Labs
• Labels and Instructions for Use (IFU) complying with regulatory standards
• Quality Management System (QMS) Documents, preferably ISO 13485 compliant

Import License Process (MD15) for Radiation Face Protectors

If you intend to import radiation face protectors, an MD15 license from the Central Licensing Authority is mandatory. The process takes approximately 5 to 6 months and involves:

• Preparation of comprehensive documentation including a valid manufacturing license, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate (if applicable), Device and Plant Master Files, and wholesale license.
• Submission of application via the CDSCO MD Online Portal.
• Departmental review and resolution of queries.
• Final grant of the import license (Form MD15).

Note that unlike manufacturing licenses, no test license is required for imports, but product validation through documentation is crucial.

Timeline and Processing Duration

Planning ahead is essential to accommodate testing, audits, and any regulatory queries.

Government Fees and Costs for Radiation Face Protector Licensing

• MD5 License (Class A device):

  • Application Fee: Rs 5,000 per application
  • Per Product Fee: Rs 500

• Test License (MD13):

  • Fees vary; consult the CDSCO portal at the time of application

• Import License (MD15):

  • Site Fee: Approximately USD 1,000 per site
  • Product Fee: USD 50 per product

Additional costs include notified body audit charges and testing fees at government-approved laboratories.

Common Challenges and Solutions

• Incomplete Documentation: One of the most frequent delays arises from incomplete or inconsistent documents. Engage experienced consultants to prepare a thorough Device Master File and Plant Master File.

• Testing Delays: Testing slots at government labs can be scarce. Early booking and alternate notified labs can mitigate this.

• Audit Non-compliance: Ensure your Quality Management System aligns strictly with CDSCO requirements and notified body expectations to avoid adverse audit findings.

• Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries, reducing back-and-forth and speeding the process.

Expert Consultation and Support

Navigating the CDSCO licensing maze demands expertise and strategic planning. With our 25+ years of regulatory consulting and over 500 successful client licenses, we offer:

• Tailored gap analysis and documentation support
• Assistance with test license applications and product testing coordination
• Comprehensive audit readiness and QMS implementation guidance
• Efficient management of CDSCO communications and query resolutions

Our proven track record ensures you avoid common pitfalls and achieve compliance swiftly.

Getting Started with Your CDSCO License Application for Radiation Face Protectors

1. Assess Your Device Classification: Confirm your radiation face protector is Class A under current MDR notifications.

2. Prepare and Submit Test License Application (MD13): Start early to accommodate testing timelines.

3. Schedule Testing at CDSCO-Approved Labs: Refer to the Testing Laboratories list to select an appropriate facility.

4. Compile Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides to ensure compliance.

5. Submit Manufacturing License Application (Form MD3) via the CDSCO MD Online Portal

6. Prepare for Notified Body Audit: Choose a notified body from the official Notified Bodies List and schedule your audit.

7. Respond Promptly to Queries: Maintain open communication channels with CDSCO and notified bodies.

By following these actionable steps and leveraging expert guidance, manufacturers can confidently bring radiation face protectors to the Indian market in compliance with all regulatory mandates.