CDSCO License for Radiation protection collar

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

As seasoned regulatory consultants with over 25 years of experience and having assisted more than 500 companies in successfully obtaining CDSCO licenses, we understand the intricacies involved in bringing medical devices like the Radiation Protection Collar to the Indian market. This personal protective equipment safeguards patients and healthcare personnel from unnecessary radiation exposure during medical and dental procedures, making regulatory compliance critical to ensure safety and market access.

CDSCO Regulatory Framework for Radiation Protection Collar

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules (MDR) 2017. The Radiation Protection Collar is categorized as a Class A device (low risk) under the MDR, reflecting its intended use as a personal protective device. Compliance with CDSCO ensures that the device meets essential safety, quality, and performance standards before it is marketed.

Risk Classification and License Requirements for Radiation Protection Collar

The Radiation Protection Collar falls under Class A (low risk) medical devices. For Class A devices, manufacturers must obtain the MD5 Manufacturing License, issued by the State Licensing Authority. This license confirms that the manufacturing premises, quality systems, and products meet regulatory standards.

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License (Form MD3)
• Regulatory Authority: State Licensing Authority
• Typical Processing Time: 3-4 months

For detailed classification references, manufacturers can consult the Medical Device Classification guide.

Manufacturing License Process (MD5) for Radiation Protection Collar

Obtaining the MD5 license involves several key steps:

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

2. Product Testing: Conduct mandatory product testing at one of the government-approved testing laboratories listed on the CDSCO Testing Laboratories portal.

3. Document Preparation: Assemble required documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) documents, and others detailed below.

4. Apply for MD5 License (Form MD3): Submit the application through the CDSCO MD Online Portal along with the required fees.

5. Audit by Notified Body: Undergo an audit by a notified body from the official list to verify compliance.

6. Query Resolution: Address any queries or deficiencies raised by the licensing authority or notified body.

7. Grant of License: Upon successful review and audit, the State Licensing Authority issues the MD5 license.

For a step-by-step procedural overview, our detailed MD5 License Guide is a valuable resource.

Manufacturing License Documents Required for Radiation Protection Collar

Successful application requires comprehensive documentation to demonstrate compliance:

• Company Constitution: Incorporation documents, partnership deed, or equivalent proof.
• Proof of Premises Ownership/Lease: Legal documents confirming possession of manufacturing site.
• Technical Staff Details: Qualifications, experience, and appointments of key personnel.
• Fire and Pollution NOCs: No Objection Certificates from relevant authorities.
• Device Master File (DMF): Detailed design, manufacturing process, and specifications. Refer to our Device Master File Guide for preparation tips.
• Plant Master File (PMF): Overview of manufacturing facilities and quality controls. Learn more from our Plant Master File Guide.
• Essential Principles Checklist: Compliance with safety and performance principles.
• Risk Management File: Documented risk analysis and mitigation strategies. Implementation guidance is available in our Risk Management article.
• Product Test Reports: Certificates from government-approved labs.
• Labels and Instructions for Use (IFU): Evidence of compliant labeling.
• Quality Management System Documents: ISO 13485 or equivalent documentation.

Import License Process (MD15) for Radiation Protection Collar

If you intend to import the Radiation Protection Collar into India, an MD15 Import License from the Central Licensing Authority is mandatory. The process includes:

• Document Preparation: Including Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, wholesale license, and company constitution.

• Application Submission: File Form MD14 on the CDSCO MD Online Portal.

• Queries and Approval: Address any departmental queries following which the license is granted in approximately 5-6 months.

Our Import License Guide offers detailed insights.

Import License Documents Required

• Valid Manufacturing License (MD5/MD9)
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Timeline and Processing Duration

Overall, manufacturers should plan for about 4 to 6 months from initial application to license grant for domestic manufacturing and longer for import licenses.

Government Fees and Costs

For the Radiation Protection Collar (Class A), the fee structure for the manufacturing license is as follows:

• MD5 Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Note that fees are payable via the CDSCO online system during application submission.

Common Challenges and Solutions

Challenge: Lengthy documentation preparation and audit readiness.

Solution: Start early with compiling comprehensive Device Master and Plant Master Files. Use templates and expert guidance to ensure all required elements are covered thoroughly.

Challenge: Delays due to queries and incomplete test reports.

Solution: Engage with government-approved testing laboratories early and ensure test reports meet CDSCO standards. Maintain open communication with auditors and licensing officers.

Challenge: Selecting an appropriate notified body for audit.

Solution: Consult the current list of notified bodies and choose one with experience in PPE and Class A devices.

Expert Consultation and Support

With decades of regulatory expertise, we provide end-to-end support, including:

• Gap analysis of existing documentation
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Application submission and query management

Our hands-on approach ensures clients navigate the CDSCO licensing process smoothly and efficiently.

Getting Started with Your CDSCO License Application for Radiation Protection Collar

1. Initiate Internal Audit: Assess your current documentation and manufacturing capabilities.
2. Engage Testing Labs: Schedule product testing early to avoid delays.
3. Prepare Documents: Use our comprehensive guides to compile Device and Plant Master Files, risk management, and QMS documentation.
4. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal to start the testing phase.
5. Schedule Audit: After test license approval and product testing, engage a notified body for the manufacturing site audit.
6. Submit MD5 License Application: Upload all documents and audit reports on the portal.
7. Respond Promptly: Address any queries from CDSCO or notified bodies quickly to avoid processing delays.

Proactive planning and expert guidance can reduce your time to market and ensure compliance with India's stringent medical device regulations. For personalized assistance with your Radiation Protection Collar licensing, reach out to our regulatory consulting team today.