CDSCO License for Partial hand radiation protector

Comprehensive Guide to CDSCO Licensing for Partial Hand Radiation Protector (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and a track record of assisting 500+ companies, we understand the intricacies involved in obtaining CDSCO licenses for medical devices. In this guide, we focus on the Partial Hand Radiation Protector, a Class A personal protective equipment designed to shield parts of the hands and fingers from primary and scattered radiation during diagnostic and therapeutic procedures.

Introduction to Partial Hand Radiation Protector and Regulatory Importance

A Partial Hand Radiation Protector is a specialized flat pad or partial glove equipped with straps to safeguard healthcare workers and patients by minimizing unnecessary radiation exposure. Given its critical safety function and classification as a Class A device under Indian medical device regulations, obtaining the correct CDSCO licensing is essential to legally manufacture or import this device in India.

Beyond legal compliance, proper licensing ensures your product meets quality, safety, and efficacy standards, instilling trust among users and healthcare providers.

CDSCO Regulatory Framework for Partial Hand Radiation Protector

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Personal Protective Equipment (PPE) like the Partial Hand Radiation Protector falls under Class A, which is the lowest risk category.

Approval for Class A devices is overseen by the State Licensing Authority through the issuance of an MD5 manufacturing license (Form MD3). This framework ensures compliance with safety standards without imposing the more rigorous central-level scrutiny reserved for higher-risk devices.

For manufacturers and importers, understanding these regulatory nuances is critical to avoid delays and ensure a smooth market entry.

Risk Classification and License Requirements for Partial Hand Radiation Protector

• Risk Class: A (Low Risk)
• Applicable License: MD5 Manufacturing License (if manufacturing in India)
• Governing Authority: State Licensing Authority
• Relevant Forms: MD3 for license application, MD13 for Test License
• Notification Details: File No. 29/Misc./03/2020-DC (186), dated 13.09.2021

The device’s classification as Class A means the application procedure is relatively streamlined but still requires due diligence, including product testing and compliance documentation.

Manufacturing License Process (MD5) for Partial Hand Radiation Protector

1. Test License Application (Form MD13)

   • Submit an application for a Test License through the CDSCO MD Online Portal.
   • This license permits manufacturing for testing purposes.
   • Processing Time: Approximately 1.5 to 2 months.

2. Product Testing

   • Conduct product testing at CDSCO-approved government laboratories listed in the Testing Laboratories Directory.
   • Tests generally cover material safety, radiation attenuation efficacy, and labeling compliance.

3. Documentation Preparation

   • Compile required documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
   • Our detailed Device Master File guide can assist in this step.

4. License Application (Form MD3)

   • Apply for the MD5 license through the online portal after successful testing.

5. Audit by Notified Body

   • Coordinate with a notified body from the official list for a mandatory audit of your manufacturing premises and quality systems.

6. Query Resolution

   • Address any queries or deficiencies raised by the State Authority or notified body promptly.

7. Grant of License

   • On satisfactory completion of the audit and document review, the MD5 license (Form MD5) is granted.

Manufacturing License Documents Required for Partial Hand Radiation Protector

• Company Constitution Documents (e.g., Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, materials, and manufacturing process
• Plant Master File (PMF) describing manufacturing environment and quality controls
• Essential Principles Checklist confirming compliance with CDSCO regulations
• Risk Management File demonstrating hazard identification and mitigation measures
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485 certified

Preparing a comprehensive and well-organized documentation package is often the most challenging part of the process. We recommend early engagement with regulatory experts to avoid common pitfalls.

Import License Process (MD15) for Partial Hand Radiation Protector

If you plan to import this device instead of manufacturing locally, you must apply for the MD15 import license via the Central Licensing Authority.

Key steps include:

• Assemble documentation such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate if applicable, Device Master File, Plant Master File, and wholesale license.
• Submit application on the CDSCO MD Online Portal.
• The processing time is approximately 5-6 months.
• Note: Test License (MD13) is not required for import applications.

Refer to our detailed Import License guide for step-by-step assistance.

Timeline and Processing Duration

Planning your timeline accordingly will help mitigate risks of unexpected delays.

Government Fees and Costs for Partial Hand Radiation Protector

• Application Fee: ₹5,000 per manufacturing site.
• Product Fee: ₹500 per product.

Additional costs to consider:

• Fees for notified body audit (varies by agency).
• Testing laboratory charges.
• Consultancy fees if engaging expert support.

Budgeting these expenses upfront is essential for smooth project planning.

Common Challenges and Solutions

Challenge 1: Incomplete or Non-compliant Documentation

• Solution: Follow detailed checklists, conduct internal audits, and seek expert reviews before submission.

Challenge 2: Delays in Testing Due to Lab Backlogs

• Solution: Schedule testing early, select multiple approved labs, and verify test scope to avoid rejections.

Challenge 3: Audit Non-conformities

• Solution: Prepare your manufacturing site according to notified body requirements, focusing on QMS and technical staff training.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated personnel for prompt reply and maintain open communication with CDSCO authorities.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for first-time manufacturers of radiation protective devices. Our team offers tailored support including:

• Documentation preparation and review
• Regulatory strategy planning
• Liaison with CDSCO and notified bodies
• Training for staff on compliance and audit readiness

Our proven expertise has enabled over 500 companies to enter the Indian market efficiently and compliantly.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification

   • Confirm your device is Class A using the Medical Device Classification tool.

2. Prepare Test License Application (MD13)

   • Gather preliminary documents and submit via the CDSCO MD Online Portal.

3. Plan Product Testing

   • Contact CDSCO-approved testing laboratories early.

4. Compile Quality and Technical Files

   • Use our Device Master File and Plant Master File guides.

5. Schedule Notified Body Audit

   • Select a notified body from the official list and book your audit.

6. Submit Final MD5 Application (Form MD3)

   • After successful testing and audit, complete your license application online.

By following these steps and leveraging expert guidance, you can efficiently obtain your manufacturing license for the Partial Hand Radiation Protector and confidently enter the Indian market.

For personalized assistance and support throughout your CDSCO licensing journey, feel free to contact our consulting team.

Note: All timelines and fees are approximate and subject to change as per CDSCO updates. Always verify current requirements on the CDSCO MD Online Portal.