CDSCO License for Radiographic Protective Glove

Introduction to Radiographic Protective Gloves and Regulatory Importance

Radiographic Protective Gloves are essential personal protective equipment designed to shield medical personnel and patients from unnecessary exposure to ionizing radiation during radiologic procedures. Classified under radiotherapy devices, these gloves serve as a critical attenuating barrier, ensuring safety in clinical environments. Given their medical importance and potential impact on health, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing or manufacturing in India.

With over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we understand the nuances and challenges manufacturers and importers face. This article provides an expert, step-by-step guide tailored specifically for Radiographic Protective Gloves, a Class B medical device, to help you navigate the regulatory framework efficiently.

CDSCO Regulatory Framework for Radiographic Protective Gloves

Radiographic Protective Gloves fall under Class B according to CDSCO’s risk classification, which categorizes medical devices based on their risk potential to patients and users. The licensing and manufacturing regulations for Class B devices are governed by the Medical Device Rules, 2017, and subsequent notifications such as the one filed under File No. 29/Misc./03/2020-DC (180) dated 6.8.2021.

Compliance with these regulations ensures that your product meets the essential principles of safety, performance, and quality mandated by Indian authorities.

Risk Classification and License Requirements for Radiographic Protective Gloves

As a Class B device, Radiographic Protective Gloves require the following:

• Manufacturing License: MD5 License (Form MD3) obtained from the State Licensing Authority.
• Test License: MD13 license required initially for product testing.
• Import License (if applicable): MD15 License from the Central Licensing Authority for importers.

The MD5 license process involves rigorous product testing, documentation, and audit to guarantee compliance with Indian standards.

Manufacturing License Process (MD5) for Radiographic Protective Gloves

The manufacturing license process for Class B devices generally spans 3 to 4 months, encompassing the following phases:

1. Apply for Test License (MD13): This takes approximately 1.5 to 2 months and allows you to legally conduct product testing at CDSCO-approved labs.
2. Product Testing: Conduct testing at government-approved laboratories to validate radiation attenuation and material safety.
3. Document Preparation: Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. License Application (MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: Engage a notified body from the list of CDSCO Notified Bodies for a plant and quality system audit.
6. Resolution of Queries: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License (MD5): Upon satisfactory compliance, the manufacturing license is issued.

Manufacturing License Documents Required

The application must include the following documents:

• Company Constitution (Incorporation Certificate & MOA/AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, materials, and manufacturing processes (Device Master File Guide)
• Plant Master File outlining manufacturing facilities and equipment (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
• Test Reports from CDSCO-approved labs (Testing Laboratories) validating radiation attenuation and biocompatibility
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents (usually ISO 13485:2016 certification)

Import License Process (MD15) for Radiographic Protective Gloves

If you plan to import Radiographic Protective Gloves into India, the process is handled by the Central Licensing Authority and takes approximately 5 to 6 months. Key steps include:

1. Document Preparation: Assemble all required import documents including manufacturing license from foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, Plant Master File, and Wholesale License.
2. Application Submission: File the import license application on the CDSCO MD Online Portal.
3. Queries Resolution: Respond promptly to any queries from CDSCO.
4. License Issuance: Upon approval, the MD15 import license is granted.

Import License Documents Required

• Manufacturing License of foreign manufacturer
• Free Sale Certificate from country of origin
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License in India
• Company Constitution documents

Timeline and Processing Duration

Planning ahead is crucial. Delays often arise from incomplete documentation, so thorough preparation saves valuable time.

Government Fees and Costs

For the Radiographic Protective Glove (Class B device), the fee structure is as follows:

• MD5 Manufacturing License:

  • Application fee: Rs. 5,000
  • Per product fee: Rs. 500

• Test License (MD13): Relevant fees paid during application

• Import License (MD15):

  • Site fee: $2,000
  • Per product fee: $1,000

Additional costs to consider include product testing fees at CDSCO-approved labs and audit fees payable to notified bodies.

Common Challenges and Solutions

1. Incomplete Documentation: Many applicants face delays due to missing or improperly prepared documents. We recommend using checklists and consulting guides such as our MD5 License Guide to ensure completeness.

2. Test Lab Delays: CDSCO-approved laboratories can have long wait times. Early booking and multiple lab options can mitigate delays.

3. Non-compliance in Audits: Notified body audits can reveal gaps in QMS or manufacturing process. Pre-audit internal reviews help avoid surprises.

4. Query Resolution Delays: Prompt and clear responses to CDSCO queries accelerate the process.

Expert Consultation and Support

Navigating CDSCO licensing can be complex, especially for innovative protective devices like Radiographic Protective Gloves. With our 25+ years of expertise and a track record of over 500 successful approvals, we assist manufacturers and importers by:

• Reviewing and preparing regulatory documentation
• Coordinating with notified bodies and CDSCO officials
• Advising on product testing strategies
• Providing training on compliance and quality systems

Our proactive approach ensures you avoid common pitfalls and expedite your market entry in India.

Getting Started with Your CDSCO License Application

To begin your journey towards obtaining the CDSCO MD5 manufacturing license for Radiographic Protective Gloves, follow these practical steps:

1. Classify Your Device: Confirm your device is Class B by consulting the Medical Device Classification.
2. Register on CDSCO MD Online Portal: Create your account and familiarize yourself with the application interface at the CDSCO MD Online Portal.
3. Apply for Test License (MD13): Submit your test license application early to secure approval for product testing.
4. Engage CDSCO-Approved Testing Laboratories: Schedule testing promptly using the Testing Laboratories list.
5. Prepare Documentation: Utilize our guides for Device Master File and Plant Master File to compile robust technical documentation.
6. Select a Notified Body: Choose an appropriate notified body for audit from the Notified Bodies List.
7. Submit Manufacturing License Application (MD3): Apply once testing and documentation are complete.
8. Prepare for Audit: Conduct internal audits and gap analyses to ensure compliance.
9. Respond to Queries: Maintain clear communication with CDSCO and notified bodies.

By systematically following these steps and leveraging expert guidance, manufacturers and importers can successfully obtain CDSCO licensing for Radiographic Protective Gloves, ensuring timely market access and regulatory compliance.

For tailored assistance and comprehensive support throughout your CDSCO licensing process, connect with our experienced team today.