CDSCO License for Radiation protection cap

Comprehensive Guide to CDSCO Licensing for Radiation Protection Caps (Class A Medical Device)

Radiation protection caps are essential Personal Protective Equipment (PPE) designed to shield medical personnel from unnecessary exposure to primary and scattered radiation during diagnostic and therapeutic procedures. Classified as Class A devices under Indian regulations, these caps require a meticulous CDSCO licensing process to ensure compliance, safety, and market access.

With over 25 years of expertise and having assisted 500+ companies in navigating CDSCO licensing, we provide you with a detailed, step-by-step guide tailored specifically for Radiation Protection Caps to help you successfully obtain your manufacturing or import license in India.

CDSCO Regulatory Framework for Radiation Protection Caps

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Radiation protection caps fall under the Personal Protective Equipment category with Risk Class A, the lowest risk class, but still subject to mandatory licensing to ensure quality and safety.

The relevant notification for Radiation Protection Caps is File No. 29/Misc./03/2020-DC (186), dated 13.9.2021, which formally classifies these devices under the CDSCO regulatory framework. This classification impacts the type of license and the approval pathway required.

Risk Classification and License Requirements for Radiation Protection Caps

As a Class A device, Radiation Protection Caps require an MD5 Manufacturing License issued by the State Licensing Authority. This license process involves multiple stages including obtaining a Test License (Form MD13), product testing, a notified body audit, and submission of detailed documentation.

Key Points:

• Risk Class: A
• License Type: MD5 (Manufacturing License)
• Licensing Authority: State Licensing Authority
• Typical Timeline: 3-4 months
• Government Fees: ₹5,000 application fee + ₹500 per product

For a comprehensive overview of device classification, see our Medical Device Classification guide.

Manufacturing License Process for Radiation Protection Caps (MD5 License)

Step 1: Obtain Test License (Form MD13)

Before applying for the MD5 license, manufacturers must secure a Test License on Form MD13. This license permits testing of the Radiation Protection Cap samples in government-approved laboratories.

• Duration: Approximately 1.5-2 months
• Purpose: Sample testing to verify compliance with applicable standards
• Testing Labs: Choose from the list of CDSCO-approved testing laboratories

Step 2: Product Testing

Submit product samples to government-approved labs for testing, which must demonstrate compliance with applicable standards related to radiation protection, material safety, and biocompatibility.

Step 3: Prepare Documentation

Compile comprehensive documents including Device Master File, Plant Master File, Quality Management System (QMS) documents, Risk Management File, test reports, labels, and Instructions for Use (IFU). Detailed guidance on creating these files is available in our Device Master File guide and Plant Master File guide.

Step 4: Apply for Manufacturing License (Form MD3)

Submit the application for the Manufacturing License on Form MD3 through the CDSCO MD Online Portal. Include all required documents and fees.

Step 5: Notified Body Audit

An audit by a notified body listed on the CDSCO Notified Bodies list will verify compliance with QMS and manufacturing practices.

Step 6: Resolution of Queries

Address any queries raised by the CDSCO department or notified body promptly to avoid delays.

Step 7: Grant of License

Upon satisfactory audit and document review, the State Licensing Authority grants the MD5 license on Form MD5.

Manufacturing License Documents Required for Radiation Protection Caps

Successful application demands a comprehensive document package including:

• Company Constitution
• Proof of ownership/lease of manufacturing premises
• Technical staff qualifications and experience
• Fire Department No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF)
• Plant Master File (PMF)
• Essential Principles Checklist
• Risk Management File (as per ISO 14971)
• Test Reports from government-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation (preferably ISO 13485 compliant)

Ensuring accuracy and completeness in these documents will significantly expedite the licensing process.

Import License Process (Not Applicable for Manufacturing)

For companies seeking to import Radiation Protection Caps, an MD15 Import License from the Central Licensing Authority is mandatory. The process involves document preparation, including manufacturing license of the product in the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device Master and Plant Master Files, wholesale license, and company constitution.

The import license process typically takes 5-6 months and involves higher fees compared to manufacturing licenses. For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration

Planning the timeline realistically helps avoid operational bottlenecks and ensures smoother market entry.

Government Fees and Costs

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product
• Additional Costs: Testing fees vary by laboratory; notified body audit fees depend on scope and notified body selected.

Budgeting for these costs upfront is essential to avoid surprises.

Common Challenges and Solutions

Challenge: Delays in Test License Approval

• Solution: Prepare complete and accurate test license applications, maintain proactive communication with the licensing authority.

Challenge: Non-compliance during Notified Body Audit

• Solution: Conduct internal audits beforehand, ensure full QMS implementation and staff training.

Challenge: Incomplete Documentation

• Solution: Use checklist templates and expert consultation to verify all documents before submission.

Challenge: Resolving Regulatory Queries

• Solution: Respond promptly with clear evidence, maintain open communication with CDSCO officials.

Expert Consultation and Support

Navigating CDSCO licensing, especially for Radiation Protection Caps, demands expertise in regulatory requirements, documentation, and procedural nuances. We provide end-to-end consultancy services including:

• Gap analysis and readiness assessment
• Document preparation and review
• Coordination with notified bodies and testing labs
• Liaison with CDSCO authorities
• Training and compliance support

Our track record with over 500 successful client engagements ensures your licensing journey is efficient and compliant.

Getting Started with Your CDSCO License Application for Radiation Protection Caps

1. Initiate a Gap Assessment: Evaluate your current manufacturing setup and documentation against CDSCO requirements.
2. Obtain a Test License: Prepare and submit your Form MD13 application via the CDSCO MD Online Portal.
3. Select Testing Laboratory: Choose an appropriate government-approved testing lab from the official Testing Laboratories list.
4. Prepare Documentation: Develop or update your Device Master File and Plant Master File, ensuring alignment with regulatory standards.
5. Engage a Notified Body: Identify and schedule your audit with a notified body from the Notified Bodies list.
6. Submit Application for MD5 License: Once testing and audit preparations are complete, apply for your manufacturing license through the CDSCO portal.

Starting early and following this structured approach will position your Radiation Protection Cap manufacturing venture for success in India’s regulated medical device market.

For further assistance or tailored consultancy, contact us to leverage our 25+ years of regulatory expertise ensuring your compliance and market readiness.

This guide is intended for informational purposes and does not substitute professional regulatory advice.