CDSCO License for Radiation protection mitten
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A personal protection device that protects the hands of the operator and other personnel from unnecessary exposure to primary radiation and scattered radiation associated with diagnosis and therapeutic measures. The mittens are also called mitts, and protect the thumb and other fingers individually or together.
Comprehensive Guide to CDSCO Licensing for Radiation Protection Mittens (Class A Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and having successfully assisted 500+ companies, we understand the intricacies manufacturers face when entering the Indian medical device market. The Radiation Protection Mitten—a Class A personal protective equipment device designed to shield operators' hands from primary and scattered radiation during diagnostic and therapeutic procedures—requires precise compliance with the Central Drugs Standard Control Organization (CDSCO) regulations.
CDSCO Regulatory Framework for Radiation Protection Mittens
Radiation protection mittens fall under the category of Personal Protective Equipment (PPE) and are classified as Class A medical devices. According to the CDSCO notification (File No. 29/Misc./03/2020-DC (186), dated 13.09.2021), these mittens must comply with the Medical Device Rules, 2017 (MDR 2017), regulated at the state level with oversight by CDSCO.
Risk Classification and License Requirements
Since Radiation Protection Mittens are Class A devices, they are considered low-risk and governed under the MD5 license scheme. The MD5 license is issued by the State Licensing Authority and involves:
- Obtaining a Test License (Form MD13) initially
- Product testing at government-approved laboratories
- Document preparation and submission
- Factory audit by a notified body
- Final license grant (Form MD5)
This process typically spans 3 to 4 months.
Manufacturing License Process (MD5) for Radiation Protection Mittens
Test License (MD13): Apply on the CDSCO MD Online Portal to get a test license. This preliminary license allows you to manufacture the device for testing purposes. Processing takes approximately 1.5 to 2 months.
Product Testing: Get your radiation protection mittens tested at one of the government-approved testing laboratories listed on the Testing Laboratories page. Testing typically includes physical, chemical, and radiation shielding efficacy tests.
Document Preparation: Prepare and compile all necessary documentation, including Device Master File and Plant Master File. Our detailed Device Master File guide and Plant Master File guide provide step-by-step instructions.
Audit by Notified Body: Engage a notified body for the factory audit. Refer to the official List of Notified Bodies to select an authorized auditor. The audit ensures compliance with Good Manufacturing Practices (GMP) and quality systems.
Final Application and License Grant: Submit Form MD3 for the MD5 Manufacturing License via the MD Online portal. After addressing any queries raised by the licensing authority or notified body, the State Licensing Authority grants the MD5 license (Form MD5).
Manufacturing License Documents Required for Radiation Protection Mittens
- Company Constitution documents (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience certificates of technical staff
- Fire Safety NOC
- Pollution Control Board NOC (if applicable)
- Device Master File detailing design, specifications, and intended use
- Plant Master File outlining manufacturing processes and quality controls
- Essential Principles Checklist confirming compliance with safety and performance
- Risk Management File analyzing hazards and mitigation strategies (learn more on risk management)
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documents (e.g., ISO 13485 compliance)
Import License Process (MD15) for Radiation Protection Mittens
For importers intending to bring Radiation Protection Mittens into India, an MD15 Import License from the Central Licensing Authority is mandatory. The process includes:
- Document preparation (manufacturing license, free sale certificate, ISO certification, CE Certificate, Device and Plant Master Files, wholesale license)
- Submission of application on the MD Online portal via Form MD14
- Addressing queries raised by CDSCO
- Grant of MD15 license
The typical processing time is 5 to 6 months. Refer to our Import License Guide for detailed steps.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) Application | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| Factory Audit by Notified Body | 2 - 3 weeks |
| Final License Application (MD5) | 3 - 4 weeks |
| Total Estimated Time | 3 - 4 months |
Government Fees and Costs
- Test License (MD13): Included in the overall process
- MD5 Manufacturing License Application Fee: INR 5,000 per application
- Additional Fee: INR 500 per product
- Audit and Testing Fees: Variable depending on notified body and testing lab rates (usually INR 50,000 to 1,00,000)
Common Challenges and Solutions
Delayed Test Reports: Delays in government-approved lab testing can stall your application. We recommend scheduling tests early and maintaining close communication with labs.
Incomplete Documentation: Missing or incorrect documents frequently cause rejection or query letters. Utilize comprehensive checklists and expert reviews.
Audit Non-conformities: Insufficient QMS implementation or manufacturing process lapses can lead to audit failures. Pre-audit internal assessments and training reduce risks.
Portal Submission Issues: Technical glitches on the CDSCO MD Online Portal are common. Ensure stable internet, use recommended browsers, and keep all digital documents ready.
Expert Consultation and Support
Navigating CDSCO licensing for Radiation Protection Mittens can be complex, but with our extensive expertise, we guide you through each step—from dossier preparation to audit readiness and post-approval compliance. Our team stays updated with regulatory amendments and works closely with notified bodies and testing labs to expedite approvals.
Getting Started with Your CDSCO License Application
- Register your company and device on the CDSCO MD Online Portal.
- Initiate the Test License (MD13) application immediately to avoid delays.
- Identify and engage a government-approved testing laboratory early.
- Begin compiling your Device Master File and Plant Master File using our detailed guides.
- Schedule a pre-audit internal assessment to ensure compliance.
By following these practical steps, manufacturers and importers of Radiation Protection Mittens can confidently enter the Indian market with a valid CDSCO license, ensuring compliance, safety, and quality.
For personalized assistance, contact our regulatory experts who have successfully supported over 500 medical device companies across India.
