CDSCO License for Ultraviolet (UV) radiation chamber disinfection device.

Introduction: Understanding the Ultraviolet (UV) Radiation Chamber Disinfection Device and Regulatory Importance

Ultraviolet (UV) radiation chamber disinfection devices are pivotal in healthcare settings, designed for the low-level surface disinfection of non-porous medical device surfaces using controlled UV irradiation. Categorized under General Hospital or Orthopaedic Instruments, these devices play a critical role in infection control protocols. Given their direct impact on patient safety, regulatory compliance is non-negotiable.

Navigating the regulatory landscape of the Central Drugs Standard Control Organization (CDSCO) is essential for manufacturers and importers aiming to market this Class C medical device in India. With over 25 years of regulatory consulting experience and having supported 500+ companies, we understand the intricacies of obtaining a CDSCO license for such devices — ensuring a smooth, timely, and compliant market entry.

CDSCO Regulatory Framework for UV Radiation Chamber Disinfection Devices

The CDSCO governs medical devices under the Medical Device Rules (MDR) 2017, amended periodically to align with global standards. For UV radiation chamber disinfection devices, classified as Class C, the licensing and regulatory oversight fall under the Central Licensing Authority. The device is notified under the Gazette Notification 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022.

This classification highlights the moderate to high risk associated with the device, necessitating a stringent review process to ensure safety, efficacy, and quality before market authorization.

Risk Classification and License Requirements

Our experience confirms that the UV radiation chamber disinfection device falls under Class C as per the CDSCO classification matrix. This mandates obtaining an MD9 Manufacturing License, which is issued by the Central Licensing Authority.

Key points:

• Risk Class: C
• License Type: MD9 (Manufacturing License for Class C and D devices)
• Application Form: MD7
• Authority: Central Licensing Authority (CDSCO HQ)

Manufacturers must undergo a comprehensive licensing procedure involving testing, documentation, and audits before approval.

Manufacturing License Process (MD9) for Class C Devices

The MD9 license process for Class C devices is detailed and typically spans 4 to 5 months. We recommend the following stepwise approach:

1. Test License (Form MD13): Initially, apply for a test license to allow product testing. This phase takes approximately 1.5 to 2 months.
2. Product Testing: Conduct mandatory product testing through government-approved laboratories. Testing ensures compliance with Indian standards and international benchmarks.
3. Document Preparation: Prepare the comprehensive dossier including technical files, quality management system documents, and risk management files.
4. Application Submission: File the manufacturing license application using Form MD7 on the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct a thorough audit of the manufacturing site, processes, and documentation.
6. Query Resolution: Address any queries or clarifications raised by CDSCO officials during the review and audit.
7. License Grant: Upon satisfactory compliance, the MD9 license is granted on Form MD9.

This structured process ensures that the manufacturing of the UV radiation chamber disinfection device meets all regulatory and quality benchmarks.

Manufacturing License Documents Required

A well-prepared documentation package accelerates approval. For MD9 license applications, the following are mandatory:

• Company Constitution Documents: Incorporation certificate, Memorandum & Articles of Association.
• Proof of Ownership of Manufacturing Premises: Lease agreement or ownership documents.
• Technical Staff Credentials: Qualification and experience details of competent technical personnel.
• Fire NOC and Pollution NOC: Compliance certificates from local authorities.
• Device Master File (DMF): Detailed device design, specifications, and manufacturing processes. Our Device Master File Guide offers comprehensive insights.
• Plant Master File (PMF): Documentation of manufacturing site, equipment, and quality controls. Refer to our Plant Master File Guide for best practices.
• Essential Principles Checklist: Confirming adherence to safety and performance requirements.
• Risk Management File: Documentation of risk analysis and mitigation strategies aligned with ISO 14971. Learn more from our Risk Management resource.
• Test Reports: Product testing certificates from CDSCO notified testing laboratories.
• Labels and Instructions for Use (IFU): Samples complying with labeling regulations.
• Quality Management System (QMS) Documents: ISO 13485 certification and related SOPs.

Having these documents meticulously prepared reduces back-and-forth with CDSCO and expedites your approval.

Import License Process (MD15) for UV Radiation Chamber Disinfection Devices

For importers, acquiring the MD15 Import License is mandatory before marketing the device in India. The process, overseen by the Central Licensing Authority, includes:

• Application submission using Form MD14 via the CDSCO MD Online Portal.
• Submission of requisite documentation (detailed below).
• Addressing queries raised during the review.
• License issuance usually within 5 to 6 months.

Unlike the manufacturing license, a test license is not required for imports.

Import License Documents Required

Importers must submit the following to support their MD15 application:

• Manufacturing License: Valid license from the country of origin.
• Free Sale Certificate: Issued by the health authority of the exporting country.
• ISO 13485:2016 Certificate: Demonstrates adherence to quality management standards.
• CE Certificate: If applicable, for devices compliant with European regulations.
• Device Master File and Plant Master File: Technical documentation and manufacturing details.
• Wholesale License: Authorization for distribution within India.
• Company Constitution Documents: Proof of registration and incorporation.

Ensure all certificates are current and translated into English if required to avoid processing delays.

Timeline and Processing Duration

Timelines may vary based on the completeness of submissions and response time to queries.

Government Fees and Costs

Understanding the financial commitment upfront is crucial:

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• MD15 Import License:

  • Class C Devices: ₹3,000 per site
  • Per Product Fee: ₹1,500

Additional costs include testing fees charged by notified laboratories and consultancy fees if you opt for expert support.

Common Challenges and Solutions

Manufacturers and importers often face challenges such as:

• Incomplete Documentation: Missing or inconsistent documents can delay processing. Solution: Use detailed checklists and pre-application audits.
• Delays in Testing: Limited capacity at notified labs may extend timelines. Solution: Plan testing schedules early and select approved laboratories from the CDSCO Testing Laboratories list.
• Audit Non-compliance: Facility or process deficiencies during audits. Solution: Conduct internal mock audits and remediate issues proactively.
• Regulatory Updates: Changing guidelines can cause confusion. Solution: Stay updated through official CDSCO notifications and expert consultations.

Our hands-on experience allows us to foresee such hurdles and implement strategies that mitigate risks effectively.

Expert Consultation and Support

With 25+ years in the CDSCO regulatory arena, we provide end-to-end assistance:

• Comprehensive gap analysis
• Tailored document preparation
• Coordination with notified bodies and testing labs
• Audit readiness training
• Query response management

Our clients benefit from expedited approvals and minimized compliance risks, ensuring timely market access.

Getting Started with Your CDSCO License Application

Ready to take the next step? Here’s a practical roadmap:

1. Assess Your Device Classification: Confirm Class C status and licensing requirements using the Medical Device Classification resource.
2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to begin product testing.
3. Engage a Notified Body: Identify and coordinate with notified bodies for audit requirements by reviewing the Notified Bodies List.
4. Prepare Documentation: Compile DMF, PMF, risk management files, and quality system documents.
5. Schedule Testing: Book slots at CDSCO-approved testing labs early to avoid delays.
6. Submit Manufacturing License Application: After successful testing and document readiness, apply using Form MD7.
7. Prepare for Audit: Ensure your manufacturing facility and processes are audit-ready.

By following these steps, you position your UV radiation chamber disinfection device for a successful CDSCO license approval.

For personalized guidance, connect with our expert regulatory team to streamline your journey into the Indian medical device market.