CDSCO License for Radiation protection gloves

Introduction to Radiation Protection Gloves and Regulatory Importance

Radiation protection gloves are essential personal protective equipment (PPE) designed to shield healthcare professionals and personnel from harmful primary and scattered radiation during diagnostic and therapeutic procedures. Given their direct impact on operator safety, these gloves must meet stringent regulatory standards before entering the Indian market.

With the notification File No. 29/Misc./03/2020-DC (186) dated 13.9.2021, radiation protection gloves are classified as Class A medical devices under CDSCO regulations. Navigating the licensing process correctly is critical to ensure compliance and timely market access.

With over 25 years of experience and support to 500+ companies, we understand the nuances of obtaining CDSCO licenses and streamline this complex journey for manufacturers and importers.

CDSCO Regulatory Framework for Radiation Protection Gloves

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Radiation protection gloves, as personal protective equipment, fall under the Class A category — the lowest risk class. This classification means licensing is managed by the respective State Licensing Authority through the MD5 license process.

The regulatory framework mandates manufacturers to secure a manufacturing license (MD5) before production or importers to obtain an import license (MD15) prior to market entry.

Risk Classification and License Requirements for Radiation Protection Gloves

• Risk Class: A (Low risk)
• License Required: MD5 Manufacturing License (Form MD3) for manufacturers
• Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months

Given the PPE nature and low-risk classification, the MD5 license process is streamlined but still requires adherence to documentation, testing, and audit procedures.

For a detailed understanding of medical device classification, refer to our comprehensive Medical Device Classification guide.

Manufacturing License Process (MD5) for Radiation Protection Gloves

1. Test License (Form MD13)

   • Obtain a test license to manufacture samples for testing.
   • Duration: 1.5 to 2 months.

2. Product Testing

   • Conduct product testing at CDSCO-approved laboratories to validate safety and efficacy.
   • Reference the list of testing laboratories.

3. Documentation Preparation

   • Prepare essential documents including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and QMS documents.

4. Application Submission (Form MD3)

   • Submit the manufacturing license application via the CDSCO MD Online Portal.

5. Audit by Notified Body

   • A notified body conducts a facility audit.
   • Find accredited auditors in the Notified Bodies List.

6. Query Resolution

   • Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License (Form MD5)

   • On successful completion, the MD5 manufacturing license is granted.

For a step-by-step walkthrough, our detailed MD5 License Guide is an invaluable resource.

Manufacturing License Documents Required for Radiation Protection Gloves

To ensure smooth processing, prepare these key documents:

• Company Constitution / Incorporation Certificate
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File detailing design, material specifications, and manufacturing processes (Device Master File guide)
• Plant Master File describing the manufacturing facility and quality controls (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management insights)
• Test Reports from government-approved laboratories
• Product Labels and Instructions For Use (IFU)
• Quality Management System (QMS) documents such as ISO 13485 certification

Organizing these documents meticulously reduces delays and audit queries.

Import License Process (MD15) for Radiation Protection Gloves

If you are an importer of radiation protection gloves, the import license is managed by the Central Licensing Authority through Form MD14 application.

Key steps include:

• Compile documents such as the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
• Submit application via the CDSCO MD Online Portal.
• Address any regulatory queries.
• Await license grant (MD15).

The import licensing process typically spans 5-6 months due to multiple layers of verification.

Our Import License Guide provides a comprehensive roadmap.

Import License Documents Required

• Valid Manufacturing License from Country of Origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution

Ensuring all certifications and files are up-to-date is critical to avoid processing delays.

Timeline and Processing Duration

Total Time for MD5 License: Approximately 3-4 months.

Our experience shows proactive document preparation and timely responses can shorten this timeline by 2-3 weeks.

Government Fees and Costs

• Application Fee: Rs. 5000 per application
• Product Fee: Rs. 500 per product

Additional costs to consider:

• Product testing fees by government-approved labs
• Notified body audit charges
• Consultancy and documentation preparation (if outsourced)

Early budgeting for these expenses ensures seamless financial planning.

Common Challenges and Solutions

Challenge 1: Delays in Product Testing

• Solution: Engage with notified testing laboratories early and confirm sample submission timelines.

Challenge 2: Incomplete Documentation

• Solution: Use detailed checklists and professional consultation to prepare complete files.

Challenge 3: Audit Non-Compliance

• Solution: Conduct internal audits and pre-assessment reviews before official audits.

Challenge 4: Query Resolution Delays

• Solution: Assign dedicated personnel for prompt communication with CDSCO and notified bodies.

Expert Consultation and Support

Our 25+ years of experience supporting over 500 companies in CDSCO licensing equips us to handle complex regulatory challenges. From documentation to audit readiness and query management, our expert consultants provide end-to-end assistance tailored for radiation protection gloves manufacturers.

We also offer training sessions on CDSCO processes and help establish compliant Quality Management Systems to ensure ongoing regulatory adherence.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification

   • Confirm radiation protection gloves as Class A medical device.

2. Gather Preliminary Documentation

   • Initiate preparation of Device Master File and Plant Master File.

3. Apply for Test License (MD13)

   • Submit test license application on the CDSCO MD Online Portal.

4. Plan Product Testing

   • Coordinate with government-approved testing labs for sample evaluation.

5. Prepare Full Manufacturing License Application (MD5)

   • Collate all documents, including risk management and QMS files.

6. Schedule Audit with Notified Body

   • Engage notified bodies early to book audit slots.

7. Submit Application and Track Progress

   • Use the online portal for status updates and query responses.

Embarking on the CDSCO licensing journey with expert guidance ensures compliance, reduces risk of rejection, and accelerates your product's market entry. Contact us today to leverage our proven expertise and make your radiation protection gloves available to the Indian healthcare sector swiftly and compliantly.