CDSCO License for Ultraviolet (UV) radiation environmental disinfection device

Comprehensive Guide to CDSCO Licensing for Ultraviolet (UV) Radiation Environmental Disinfection Devices (Class B)

As specialists with over 25 years of experience in medical device regulatory compliance, we have assisted more than 500 companies in successfully navigating the CDSCO licensing process. Today, we focus on the Ultraviolet (UV) radiation environmental disinfection device, classified as a Class B medical device under the category of General Hospital or Orthopaedic Instruments. This guide offers detailed, practical steps and insights for manufacturers aiming to enter the Indian market with this sophisticated medical air purification technology.

Introduction: Understanding the UV Radiation Environmental Disinfection Device and Its Regulatory Importance

The UV radiation environmental disinfection device is designed for medical settings such as hospitals and clinics to inactivate airborne bacteria using ultraviolet light. Given its medical purpose and impact on patient safety, strict regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is mandatory before market entry.

The device falls under Class B risk classification, indicating low to moderate risk. Proper licensing ensures compliance with Indian safety, quality, and performance standards—critical for protecting public health and enabling smooth market access.

CDSCO Regulatory Framework for UV Radiation Environmental Disinfection Devices

The regulatory framework for medical devices like this UV air purifier is governed by the Medical Device Rules (MDR) 2017 and subsequent notifications. The device is listed under the notification number 29/Misc./03/2020-DC (193)- Part-3, dated 16.03.2022, which defines its classification and regulatory requirements.

For Class B devices, the licensing authority is the State Licensing Authority, and the required license type is MD5 (Manufacturing License for Class A and B devices).

Risk Classification and License Requirements

• Risk Class: B (Low to moderate risk)
• License Type: MD5 License (Form MD3 application)
• Authority: State Licensing Authority
• Applicable Standards: Compliance with essential principles outlined by CDSCO, including electrical safety, biocompatibility, and efficacy of UV radiation

For detailed classification criteria, you may refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process for MD5 (Class B Devices)

The MD5 license process is multi-step and typically spans approximately 3 to 4 months. Here's a breakdown:

1. Test License (Form MD13): Before applying for the manufacturing license, obtain a test license. This takes 1.5 to 2 months.

2. Product Testing: Get the UV device tested at CDSCO-approved government laboratories to verify compliance with safety and performance standards. You can check the list of Testing Laboratories authorized for this purpose.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Submit the MD5 license application using Form MD3 via the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct an on-site audit of your manufacturing facility. You can find the list of approved notified bodies here.

6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.

7. License Grant: Upon successful review and audit clearance, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for UV Disinfection Devices

Accurate and complete documentation is key to expediting your license approval. For a Class B UV radiation environmental disinfection device, you will need:

• Company Constitution Documents: Incorporation certificate, partnership deed, or equivalent
• Proof of Ownership or Lease of Manufacturing Premises: Valid property documents
• Technical Staff Details: Qualification and experience of technical personnel involved in manufacturing
• Fire and Pollution NOCs: No Objection Certificates from local authorities
• Device Master File (DMF): Detailed device description, specifications, and manufacturing process; see our Device Master File guide
• Plant Master File (PMF): Manufacturing facility layout, equipment, and quality control processes; refer to our Plant Master File guide
• Essential Principles Checklist: Compliance confirmation with applicable standards
• Risk Management File: Hazard analysis and mitigation strategies; check our Risk Management guide
• Test Reports: Results from government-approved labs demonstrating conformity
• Labels and Instructions for Use (IFU): Product labeling and user manuals
• Quality Management System (QMS) Documents: Including ISO 13485 certification

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

If you are an importer aiming to bring this Class B device into India, an MD15 import license is required. The process is managed by the Central Licensing Authority and typically takes 5 to 6 months.

Unlike the manufacturing license, a test license is not mandatory for imports. However, you must prepare and submit extensive documentation including:

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate or equivalent international compliance
• Device Master File and Plant Master File
• Wholesale drug license
• Company constitution and proof of business registration

Applications are submitted via the CDSCO MD Online Portal, using Form MD14 for MD15 license applications.

Import License Documents Required

• Manufacturing License of the device from the exporting country
• Free Sale Certificate confirming the device is marketed freely in the country of origin
• ISO 13485:2016 Certificate demonstrating quality management compliance
• CE Mark or equivalent international certification
• Detailed Device Master File and Plant Master File
• Wholesale license issued by the State
• Constitution documents of the importing company

Timeline and Processing Duration

For import licenses (MD15), the total timeline is approximately 5 to 6 months.

Government Fees and Costs

For MD5 manufacturing license applications for Class B devices:

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

Additional costs may include:

• Testing fees at government-approved labs (varies by test complexity)
• Notified body audit fees (depend on audit scope)
• Consultancy and documentation preparation fees

Being aware of these costs upfront helps in budgeting and avoiding delays.

Common Challenges and Practical Solutions

Challenge 1: Delays in Testing and Audit Scheduling

• Solution: Pre-book testing slots with authorized labs and schedule audits early. Maintaining good communication with notified bodies and labs can expedite processes.

Challenge 2: Documentation Gaps Leading to Query Backlogs

• Solution: Use comprehensive checklists aligned with CDSCO requirements. Our guides on Device Master Files and Risk Management are excellent resources.

Challenge 3: Non-compliance with Essential Principles

• Solution: Conduct internal pre-audits and ensure all electrical safety and biocompatibility standards are met.

Challenge 4: Misclassification Leading to Incorrect License Applications

• Solution: Verify your device classification carefully by consulting regulatory experts or referring to CDSCO classification guidelines.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for UV radiation environmental disinfection devices requires nuanced understanding and meticulous preparation. As seasoned consultants, we offer tailored support including:

• Pre-assessment of device classification and regulatory pathway
• Documentation preparation and review
• Coordination with notified bodies and testing labs
• Training for your technical staff on compliance requirements
• End-to-end application management to minimize delays

Our hands-on approach has enabled numerous manufacturers and importers to achieve timely approvals and successful market access.

Getting Started with Your CDSCO License Application

If you are ready to enter the Indian market with your UV radiation environmental disinfection device, here are practical next steps:

1. Review Your Device Classification: Confirm your device as Class B under the current notifications.

2. Initiate the Test License Application (if manufacturing): File Form MD13 via the CDSCO MD Online Portal.

3. Engage with CDSCO-Approved Testing Labs: Schedule product testing early to prevent bottlenecks.

4. Prepare Comprehensive Documentation: Utilize expert-developed templates for DMF, PMF and Risk Management files.

5. Schedule Notified Body Audit: Select an accredited notified body from the official list and arrange the audit.

6. Submit Application for Manufacturing License (MD5): Use Form MD3 via the online portal.

7. Monitor Application Progress & Respond to Queries: Maintain proactive communication.

By following these steps with expert guidance, you position your device for a smooth and compliant entry into India's healthcare sector. For personalized assistance, reach out to our regulatory team and leverage our extensive experience in CDSCO licensing.

For further information on MD5 licensing, please see our detailed MD5 License Guide.

To explore import licensing specifics, visit our Import License Guide.

Your journey to compliance and market success starts here—partner with us to make it efficient and hassle-free.