CDSCO License for Radiation protection blanket

Introduction to Radiation Protection Blanket and Regulatory Importance

Radiation protection blankets are vital personal protective equipment (PPE) designed to shield patients, medical personnel, and operators from unnecessary exposure to radiation during diagnostic and therapeutic medical or dental procedures. As a Class A medical device under the Indian regulatory framework, these blankets fall under the lowest risk category, but their safety and efficacy are nonetheless critical to protect health and ensure compliance.

Navigating the CDSCO licensing process is essential for manufacturers and importers aiming to legally market radiation protection blankets in India. With over 25 years of experience assisting 500+ companies, we understand the complexities involved and provide practical guidance to streamline your compliance journey.

CDSCO Regulatory Framework for Radiation Protection Blankets

Radiation protection blankets are notified under File No. 29/Misc./03/2020-DC (186), dated 13.9.2021, as personal protective equipment. They are regulated by the Central Drugs Standard Control Organisation (CDSCO) and classified as Class A devices based on risk.

Manufacturing or importing these devices requires obtaining the appropriate licenses under the Medical Device Rules, 2017. The manufacturing license for Class A devices is issued by the State Licensing Authority as an MD5 license, while import licenses are issued by the Central Licensing Authority as an MD15 license.

Risk Classification and License Requirements for Radiation Protection Blankets

• Risk Class: A (Low Risk)
• License for Manufacturing: MD5 License (Form MD3 application)
• License for Import: MD15 License (Form MD14 application)

Class A devices, like radiation protection blankets, require a State-level manufacturing license (MD5), which involves several steps including obtaining a test license (MD13), product testing by CDSCO-approved labs, document preparation, and notified body audits.

Manufacturing License Process for Radiation Protection Blankets (MD5)

The manufacturing license acquisition for radiation protection blankets typically spans 3 to 4 months and involves the following stages:

1. Test License Application (Form MD13): Apply to the State Licensing Authority for a test license to manufacture the product for testing purposes. This process takes approximately 1.5 to 2 months.

2. Product Testing: Send samples to CDSCO-approved testing laboratories for evaluation of compliance with applicable standards. Testing duration varies but usually completes within 3 to 4 weeks.

3. Documentation Preparation: Prepare a comprehensive set of documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, Quality Management System (QMS) documents, labels, and Instructions for Use (IFU).

4. MD5 License Application (Form MD3): Submit your application through the CDSCO MD Online Portal, including all required documents and test reports.

5. Notified Body Audit: Engage a notified body from the official list for a manufacturing site audit to verify compliance with Good Manufacturing Practices (GMP) and QMS.

6. Responding to Queries: Promptly address any observations or queries raised by the notified body or State Licensing Authority.

7. Grant of MD5 License (Form MD5): Upon satisfactory compliance, the license is granted, enabling you to manufacture radiation protection blankets legally in India.

Manufacturing License Documents Required for Radiation Protection Blankets

To facilitate a smooth application process, ensure the following documents are meticulously prepared and submitted:

• Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
• Proof of ownership or lease agreement for the manufacturing premises
• Details and qualifications of technical staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes. Our detailed Device Master File guide can assist.
• Plant Master File (PMF) describing the manufacturing site and facilities. Learn how to create an effective Plant Master File here.
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File documenting hazard analysis and mitigation strategies. Refer to our Risk Management guide for best practices.
• Product Test Reports from CDSCO-approved laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably compliant with ISO 13485:2016

Import License Process for Radiation Protection Blankets (MD15)

For importers, obtaining an MD15 license is mandatory before marketing radiation protection blankets in India. The process typically takes 5 to 6 months and involves:

1. Document Preparation: Assemble all required documents including manufacturing licenses from the country of origin, Free Sale Certificates, ISO 13485:2016 certification, CE certificates, Device Master File, Plant Master File, wholesale license, and company constitution.

2. Application Submission: Submit the application using Form MD14 on the CDSCO MD Online Portal.

3. Review and Queries: Address any queries raised by CDSCO during the evaluation.

4. Grant of Import License (Form MD15): On successful review, the import license is granted.

Note that unlike manufacturing licenses, an import license does not require a test license or product testing by Indian laboratories.

Import License Documents Required for Radiation Protection Blankets

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority of the exporting country
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license under the Drugs and Cosmetics Act
• Company Constitution documents

Timeline and Processing Duration

Adhering strictly to the documentation requirements and timely responses to queries can help avoid delays.

Government Fees and Costs

For the MD5 manufacturing license relevant to radiation protection blankets (Class A):

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

For the MD15 import license, fees vary by risk class and site:

• Class A: Approximately $1,000 per site plus$50 per product

Additional costs to budget for include notified body audit fees, product testing charges from government-approved labs, and consultancy fees if you engage expert help.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Choose CDSCO-approved labs with faster turnaround times and maintain good communication to expedite the process. Check the Testing Laboratories list for options.

Challenge 2: Incomplete Documentation Leading to Queries

• Solution: Use checklists and expert guidance to compile comprehensive and accurate documents. Refer to our Device and Plant Master File guides for detailed assistance.

Challenge 3: Audit Non-compliance

• Solution: Prepare your manufacturing facility thoroughly by implementing a robust QMS and conducting mock audits before the notified body visit.

Challenge 4: Managing Timelines

• Solution: Plan your licensing activities well in advance, considering the cumulative duration of test licenses, product testing, audits, and application processing.

Expert Consultation and Support

With over 500 successful CDSCO licensing projects under our belt, we provide end-to-end support from initial classification to final license grant. Our expertise covers document preparation, audit readiness, liaison with CDSCO authorities, and post-license compliance.

Engaging experienced consultants can significantly reduce your time to market and mitigate risks associated with regulatory non-compliance.

Getting Started with Your CDSCO License Application for Radiation Protection Blankets

1. Classify Your Device: Confirm your device as Class A under CDSCO rules.
2. Prepare Documentation: Start compiling your Device Master File, Plant Master File, QMS, and other mandatory documents using our detailed guides.
3. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to begin manufacturing samples for testing.
4. Arrange Product Testing: Coordinate sample submission to approved laboratories.
5. Engage Notified Body: Identify and schedule audit with a notified body from the official list.
6. Submit MD5 License Application: After successful testing and audit, apply for your manufacturing license.
7. Monitor Application Progress: Respond promptly to all queries and prepare for license issuance.

Taking these actionable steps with expert guidance ensures a smooth, compliant, and timely entry of your radiation protection blankets into the Indian medical device market.