CDSCO License for Laser irradiation therapy kit

Comprehensive Guide to CDSCO Licensing for Laser Irradiation Therapy Kit (Class B Radiotherapy Device)

Laser irradiation therapy kits, comprising components such as puncture needles, guide wires, and guiding sheaths, play a pivotal role in radiotherapy by facilitating precise laser probe guidance. Given their medical significance and patient safety implications, obtaining the correct regulatory approvals from the Central Drugs Standard Control Organisation (CDSCO) is mandatory before marketing these devices in India.

With over 25 years of experience and having assisted more than 500 companies in navigating the CDSCO regulatory landscape, we provide you a detailed, step-by-step roadmap for securing your manufacturing or import license for this Class B device under Notification File No. 29/Misc./03/2020-DC (180), dated 6.8.2021.

CDSCO Regulatory Framework for Laser Irradiation Therapy Kits

Laser irradiation therapy kits fall under the radiotherapy category and are classified as Class B medical devices by CDSCO, indicating a moderate risk profile. India’s regulatory framework mandates compliance with the Medical Device Rules, 2017, with licensing governed by state or central authorities based on device classification. For Class B devices, the manufacturing license (MD5) is issued by the State Licensing Authority, whereas import licenses (MD15) are granted by the Central Licensing Authority.

It is essential to adhere to the notified standards, including quality management systems (ISO 13485:2016), risk management protocols, and essential principles of safety and performance.

Risk Classification and License Requirements for Laser Irradiation Therapy Kits

As a Class B device, the laser irradiation therapy kit requires the following:

• Manufacturing License (MD5): Granted by the State Licensing Authority.
• Test License (MD13): Mandatory initial step to conduct product testing at CDSCO-recognized labs.
• Import License (MD15): If importing, application is made to the Central Licensing Authority.

Class B devices are subject to moderate regulatory controls, including product testing, audit by notified bodies, and comprehensive documentation.

Manufacturing License Process (MD5) for Class B Devices

The MD5 license process is a multi-stage journey spanning around 3 to 4 months, designed to ensure compliance and product safety:

1. Apply for Test License (Form MD13): This initial step permits product testing in approved laboratories and typically takes 1.5 to 2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved labs to validate device safety and performance. Refer to the list of testing laboratories for authorized facilities.
3. Document Preparation: Compile all required documentation, including Device Master File (DMF) and Plant Master File (PMF).
4. Application Submission (Form MD3): Submit the manufacturing license application for MD5 through the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage an authorized notified body for a facility audit. Check the list of notified bodies to select a suitable auditor.
6. Resolution of Queries: Address any observations from CDSCO or the notified body promptly.
7. Grant of License (Form MD5): Upon clearance, the State Licensing Authority issues the manufacturing license.

Manufacturing License Documents Required for Laser Irradiation Therapy Kits

Accurate and thorough documentation is critical. For your Class B laser irradiation therapy kit, prepare the following:

• Company constitution and registration certificates
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire and pollution NOCs
• Complete Device Master File (DMF) outlining device specifications, manufacturing processes, and compliance
• Plant Master File (PMF) detailing manufacturing facility layout and quality systems
• Essential Principles Checklist demonstrating adherence to safety and performance standards
• Risk Management File documenting hazard analysis and mitigation strategies
• Test reports from CDSCO-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Our detailed Device Master File guide and Plant Master File guide can help streamline this process.

Import License Process (MD15) for Laser Irradiation Therapy Kits

If you intend to import the laser irradiation therapy kit into India, the MD15 license is mandatory. This process typically takes about 5 to 6 months and involves:

1. Document Preparation: Gather key certificates such as ISO 13485:2016, CE certificate, free sale certificate from the country of origin, along with the manufacturing license.
2. Application Submission: File Form MD14 on the CDSCO MD Online Portal.
3. Departmental Review and Queries Resolution: CDSCO scrutinizes submitted documents and may seek clarifications.
4. Grant of Import License (Form MD15): Upon satisfactory review, the license is issued by the Central Licensing Authority.

Documents required include:

• Manufacturing license from country of origin
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license if applicable
• Company registration documents

Refer to our comprehensive Import License guide for detailed assistance.

Timeline and Processing Duration

Planning your submission timeline with these durations in mind helps avoid costly delays.

Government Fees and Costs

For your Class B laser irradiation therapy kit, fees are as follows:

• MD5 Manufacturing License:
  • Rs 5,000 per application
  • Rs 500 per product
• MD13 Test License:
  • Included in MD5 process; nominal fees applicable
• MD15 Import License:
  • USD 1,000 per site
  • USD 50 per product

Additional costs include audit fees charged by notified bodies and laboratory testing charges, which vary by laboratory and test complexity.

Common Challenges and Solutions

• Incomplete Documentation: Many manufacturers face delays due to missing or inconsistent documents. Use checklists and expert reviews to ensure completeness.
• Prolonged Testing Durations: Testing at government-approved labs can be slow; plan submissions well in advance.
• Audit Non-Compliance: Facilities often lack preparedness for notified body audits. Conduct internal pre-audits and corrective actions beforehand.
• Query Resolution Delays: Timely and precise responses to CDSCO queries expedite approvals. Maintain open communication channels.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for integrated kits like the laser irradiation therapy device. Our team, with decades of regulatory experience, offers:

• Tailored regulatory strategy and gap analysis
• Documentation preparation and review assistance
• Coordination with notified bodies and testing labs
• End-to-end license application management

This proactive support reduces approval timelines and mitigates compliance risks.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device as Class B under the CDSCO medical device classification system. You can cross-check the classification here: Medical Device Classification.
2. Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
3. Engage with Approved Testing Laboratories: Schedule and conduct mandatory product testing.
4. Compile Comprehensive Documentation: Utilize our Device Master File guide and Plant Master File guide to streamline document creation.
5. Identify and Coordinate with a Notified Body: Select a notified body from the official CDSCO list for your audit.
6. Submit Your Manufacturing License Application (MD5): File Form MD3 through the online portal.
7. Prepare for and Facilitate Audit: Ensure your facility and QMS are audit-ready.
8. Address CDSCO Queries Promptly: Maintain diligent communication.

For importers, parallel steps involve compiling import-specific documentation and applying for the MD15 license.

Embarking on this process with experienced guidance ensures that your laser irradiation therapy kit reaches the Indian market efficiently and compliantly. Contact us to leverage our expertise and accelerate your CDSCO licensing journey.