CDSCO License for Mobile radiation protection barrier
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 stand-alone, movable barrier that protects the operator etc. from unnecessary exposure to radiation used for medical diagnosis, treatment and dental procedures.
Mobile Radiation Protection Barrier: CDSCO Licensing and Regulatory Overview
Mobile Radiation Protection Barriers serve as essential personal protective equipment (PPE) designed to shield operators from unnecessary radiation exposure during medical diagnostics, treatments, and dental procedures. Classified as Class A under CDSCO’s risk classification, these movable barriers require a streamlined regulatory pathway to ensure compliance and market entry in India.
With over 25 years of experience and having guided 500+ manufacturers and importers, we provide comprehensive insights into the licensing process for Mobile Radiation Protection Barriers, addressing common concerns and delivering actionable steps.
CDSCO Regulatory Framework for Mobile Radiation Protection Barriers
The Central Drugs Standard Control Organization (CDSCO) governs the import, manufacture, and sale of medical devices in India, including PPE such as Mobile Radiation Protection Barriers. Following the Medical Device Rules (MDR) 2017, these devices fall under Class A, considered low risk, and are regulated by the State Licensing Authority.
The regulatory framework mandates:
- Obtaining a Manufacturing License (MD5) for local production
- Securing an Import License (MD15) for bringing devices into India
- Compliance with Essential Principles, Quality Management System (QMS), and documentation requirements
Manufacturers must submit applications through the CDSCO MD Online Portal to ensure transparency and efficiency.
Risk Classification and License Requirements for Class A Devices
Mobile Radiation Protection Barriers are classified as Class A, the lowest risk category. Under MDR 2017:
- Manufacturing License: MD5 License (Application Form MD3), issued by the State Licensing Authority
- Import License: MD15 License, issued by the Central Licensing Authority
The MD5 license process typically requires 3-4 months, including testing and audit, while import licenses require 5-6 months.
Manufacturing License Process (MD5) for Mobile Radiation Protection Barriers
The MD5 licensing procedure involves several key stages:
- Obtain Test License (Form MD13): Required for initial product testing; process takes approximately 1.5-2 months.
- Product Testing: Conducted at CDSCO-approved laboratories, such as those listed on the Testing Laboratories portal.
- Documentation Preparation: Compile technical and quality documents including Device Master File and Plant Master File.
- Application Submission (Form MD3): Submit manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: State-authorized notified bodies conduct facility audits; refer to the Notified Bodies List.
- Query Resolution: Address any queries raised during audit or by CDSCO officials.
- License Grant (Form MD5): Upon satisfactory compliance, license is issued.
For a Class A device like the Mobile Radiation Protection Barrier, the entire process averages 3-4 months.
Manufacturing License Documents Required for Mobile Radiation Protection Barriers
To ensure a smooth application, prepare the following documentation:
- Company Constitution/Registration Certificate: Proof of legal entity
- Proof of Ownership/Lease of Manufacturing Premises: Valid property documents
- Technical Staff Details: Qualifications and experience of personnel
- Fire NOC & Pollution Control NOC: Safety and environmental clearances
- Device Master File (DMF): Detailed product specifications and design; our Device Master File guide offers a step-by-step approach
- Plant Master File (PMF): Manufacturing processes and quality system overview; see our Plant Master File guide
- Essential Principles Checklist: Compliance with MDR 2017 essential principles
- Risk Management File: Risk analysis and mitigation in line with ISO 14971; recommended reading on Risk Management
- Test Reports: From CDSCO-approved labs
- Labels and Instructions for Use (IFU): Clear, compliant labeling
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal procedures
Import License Process (MD15) for Mobile Radiation Protection Barriers
While primarily focused on manufacturing, importers should be aware of the MD15 license process:
- Document Preparation: Includes Manufacturing License, Free Sale Certificate from country of origin, ISO 13485 certification, CE Certificate, DMF, PMF, Wholesale License, and Company Constitution.
- Application Submission (Form MD14): Filed via the CDSCO MD Online Portal.
- Query Resolution: Respond timely to any CDSCO queries.
- License Grant (Form MD15): Issued by Central Licensing Authority within 5-6 months.
Import license fees vary by device class; for Class A devices, expect approximately 50 per product.
Import License Documents Required
- Valid Manufacturing License (MD5 or MD9) from country of origin
- Free Sale Certificate (FSC)
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and Address Proof
Timeline and Processing Duration
| License Type | Timeline (Approx.) | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Product testing approval |
| Manufacturing License (MD5) | 3 - 4 months | Audit, document review, and license grant |
| Import License (MD15) | 5 - 6 months | Document scrutiny and license issuance |
Planning ahead and ensuring thorough documentation reduces delays significantly.
Government Fees and Costs
- MD5 Manufacturing License:
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
- Test License (MD13): Separate application fees apply
For a typical Mobile Radiation Protection Barrier, budget approximately INR 10,000 - 15,000 for government fees, excluding internal costs for testing, audits, and documentation.
Common Challenges and Solutions
- Incomplete Documentation: Many applicants face delays due to missing or inadequate Device Master Files or Risk Management documentation. We advise early preparation using our comprehensive guides.
- Audit Non-Compliance: Facilities may lack proper QMS implementation. Conduct internal audits prior to notified body inspections.
- Testing Delays: Schedule tests well in advance with CDSCO-approved labs to avoid bottlenecks.
- Query Resolution: Prompt and clear responses to CDSCO queries expedite approvals.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time applicants. Our 25+ years of regulatory expertise and track record with 500+ clients ensure you receive tailored support:
- Document preparation and review
- Audit readiness and gap analysis
- Coordination with notified bodies and testing labs
- Real-time application tracking via the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class A status; refer to our Medical Device Classification.
- Prepare Documentation: Develop DMF, PMF, Risk Management files, and test samples.
- Apply for Test License (MD13): Submit application through the CDSCO MD Online Portal.
- Schedule Testing: Coordinate with approved laboratories.
- Compile Manufacturing License Application (MD3): Include all required documents.
- Engage Notified Body: Arrange audit after test reports are ready.
- Submit Application and Track Progress: Use the online portal for timely updates.
For detailed assistance, explore our MD5 License Guide for step-by-step instructions tailored to Class A devices like Mobile Radiation Protection Barriers.
Embarking on your CDSCO licensing journey with expert guidance ensures a compliant, efficient, and successful market entry for your Mobile Radiation Protection Barrier in India.
