CDSCO License for Stationary radiation protection barrier

Comprehensive Guide to CDSCO Licensing for Stationary Radiation Protection Barrier (Class B Device)

As specialists with over 25 years of experience and having successfully guided 500+ companies through the regulatory landscape, we understand the nuances of obtaining CDSCO licenses in India. Today, we’ll provide an in-depth, practical roadmap for manufacturers and importers seeking approval for the Stationary Radiation Protection Barrier, a Class B medical device used in radiotherapy.

Introduction: Understanding Your Device and Regulatory Importance

The Stationary Radiation Protection Barrier is a critical device designed for permanent installation to shield or attenuate radiation emitted from primary or scattered radiation sources. Given its role in radiotherapy — where patient and staff safety is paramount — regulatory compliance with CDSCO (Central Drugs Standard Control Organization) is mandatory before commercializing this device in India.

CDSCO governs medical device licensing to ensure safety, efficacy, and quality. For Class B devices like this radiation barrier, obtaining an MD5 Manufacturing License is required from the State Licensing Authority. This license confirms that your manufacturing process meets all regulatory standards.

CDSCO Regulatory Framework for Stationary Radiation Protection Barrier

The device falls under the Radiotherapy category and is classified as Class B (Low Moderate Risk) per the CDSCO classification notified under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021. This categorization dictates the route for licensing and compliance.

Manufacturers must adhere to the Medical Device Rules, 2017, including compliance with essential principles, quality management systems (typically ISO 13485:2016), and product testing.

Risk Classification and License Requirements for Class B Devices

Per CDSCO classification, Class B devices require:

• Test License (Form MD13): Initial permission to manufacture and test the device.
• Manufacturing License (Form MD5): The full manufacturing license issued post successful audit and compliance verification.

The licensing process involves product testing at government-approved laboratories, document submission, and an audit by a notified body.

Step-by-Step Manufacturing License Process (MD5) for Your Device

1. Obtain Test License (Form MD13): Apply on the CDSCO MD Online Portal for a test license, which takes approximately 1.5 to 2 months. This license allows you to legally manufacture the device for testing purposes.

2. Product Testing: Get your Stationary Radiation Protection Barrier tested for compliance at one of the CDSCO-approved testing laboratories. Testing typically takes 1-2 months depending on lab schedules.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, risk management file, essential principles checklist, and quality management system documents.

4. Apply for Manufacturing License (Form MD3 for MD5 License): Submit your application through the CDSCO MD Online Portal. This triggers the next phase.

5. Audit by Notified Body: An audit by a notified body listed here will be conducted, focusing on manufacturing premises, quality processes, and compliance.

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

7. License Grant: Upon satisfactory completion, the State Licensing Authority grants the MD5 license on Form MD5.

Manufacturing License Documents Required for Stationary Radiation Protection Barrier

Ensure you have the following documents ready to streamline your application:

• Company Constitution (e.g., Memorandum & Articles of Association)
• Proof of ownership or lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed device specifications, manufacturing process, and technical data (Learn more)
• Plant Master File (PMF): Facility layout, equipment details, and quality assurance measures (Learn more)
• Essential Principles Checklist demonstrating compliance
• Risk Management File documenting identified hazards and mitigations (Detailed guide)
• Product Test Reports from approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification preferred)

Import License Process (MD15) for Stationary Radiation Protection Barrier

If you intend to import this device, you must apply for an MD15 Import License from the Central Licensing Authority. This process differs as you do not require a test license but must submit relevant documentation such as:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution

The application is made via the CDSCO MD Online Portal and typically takes 5-6 months for processing.

Import License Documents Required

• Manufacturing License issued by the competent authority of the exporting country
• Free Sale Certificate for the device
• ISO 13485:2016 certification
• CE Marking Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license applicable in India
• Company Constitution documents

Timeline and Processing Duration

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

Government Fees and Costs

For MD5 Manufacturing License (Class B device):

• Application Fee: Rs. 5,000
• Per Product Fee: Rs. 500

Additional costs will include testing laboratory fees and notified body audit charges.

For Import License (MD15):

• Site Fee (Class B): Rs. 1,50,000 approx. ($2000)
• Per Product Fee (Class B): Rs. 75,000 approx. ($1000)

Note: Fees are subject to change; always verify current rates on the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Schedule testing early and select accredited labs with capacity. Maintain good communication to avoid bottlenecks.

Challenge 2: Incomplete Documentation

• Solution: Use checklists and templates for Device and Plant Master Files. Our Device Master File guide can help ensure completeness.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal audits before notified body visits. Train staff on compliance and documentation.

Challenge 4: Query Resolution Delays

• Solution: Respond promptly with detailed evidence and clarifications. Engage experienced consultants to draft responses if needed.

Expert Consultation and Support

Navigating CDSCO licensing for radiation protection barriers can be complex. Our team has successfully supported over 500 companies, helping them avoid pitfalls and expedite approvals. Whether it is document preparation, coordinating with testing labs, or preparing for audits, expert guidance can make a decisive difference.

Getting Started with Your CDSCO License Application

1. Assess your device classification and gather all relevant technical data.
2. Initiate the application for the Test License (Form MD13) via the CDSCO MD Online Portal.
3. Engage with accredited testing laboratories early to schedule product testing.
4. Prepare your Device Master File, Plant Master File, risk management files, and QMS documentation concurrently.
5. Identify and appoint a notified body for the mandatory audit.
6. Plan for timely query resolution and maintain open channels with CDSCO officers.

By following these actionable steps and leveraging our expertise, you can efficiently secure your MD5 manufacturing license and confidently bring your Stationary Radiation Protection Barrier to the Indian healthcare market.

For personalized assistance, document review, or audit preparation, reach out to our regulatory consultancy. We are committed to helping you achieve compliance swiftly and smoothly.