CDSCO License for Medical image storage device
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 medical image storage device is a device that provides electronic storage and retrieval functions for medical images. Examples include devices employing magnetic and optical discs, magnetic tape, and digital memory.
Comprehensive Guide to CDSCO Licensing for Medical Image Storage Devices (Class A)
As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies in securing CDSCO licenses, we understand the critical importance of compliance in bringing medical devices like Medical Image Storage Devices to the Indian market. These devices, classified under Class A risk and falling within Interventional Radiology, require meticulous adherence to the CDSCO regulatory framework to ensure swift approval and market access.
Understanding Medical Image Storage Devices and Their Regulatory Importance
A Medical Image Storage Device is designed to provide electronic storage and retrieval functions for medical images, utilizing technologies such as magnetic and optical discs, magnetic tape, and digital memory. Given their role in diagnostic and interventional radiology workflows, ensuring data integrity, security, and compliance with regulatory standards is paramount.
The Central Drugs Standard Control Organization (CDSCO) regulates such devices to safeguard patient safety and maintain quality standards. For Class A devices like these, obtaining an MD5 Manufacturing License is mandatory before commercialization in India.
CDSCO Regulatory Framework for Medical Image Storage Devices
Medical Image Storage Devices are notified under the government notification [29/Misc./03/2020-DC (146)] dated 26.07.2021. Classified as Class A devices, these fall under the lowest risk category, but still require compliance with the Medical Device Rules, 2017.
The licensing framework for Class A devices involves the State Licensing Authority, which grants the MD5 license (Application Form MD3). The process is designed to ensure that manufacturers meet quality and safety standards through a combination of document verification, product testing, and site audits.
Risk Classification and License Requirements
| Risk Class | License Type | Regulatory Authority | Timeline | Fees |
|---|---|---|---|---|
| Class A | MD5 | State Licensing Authority | 3-4 months | Rs 5000 + Rs 500 per product |
For your Medical Image Storage Device, the MD5 license process applies, requiring:
- Test License (Form MD13)
- Product Testing from CDSCO-approved labs
- Audit by a notified body
- Submission of essential documentation
Manufacturing License Process (MD5) for Medical Image Storage Devices
The MD5 licensing process comprises the following sequential steps:
Test License Application (Form MD13): Initially, manufacturers must apply for a test license, which typically takes 1.5 to 2 months for approval.
Product Testing: Following the test license, your device samples must undergo testing in government-approved laboratories. For your device, ensure functional and safety testing per applicable standards. You can refer to the list of CDSCO-approved testing laboratories for selection.
Document Preparation: While testing is underway, prepare comprehensive documentation, including Device Master File and Plant Master File, essential principles checklist, risk management files, and quality management system documents.
Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit of your manufacturing facility is conducted by a notified body accredited under CDSCO. Check the list of notified bodies to select an appropriate auditor.
Query Resolution: Address any queries raised by the State Licensing Authority or notified body promptly.
Grant of MD5 License: Upon satisfactory review and audit, the MD5 manufacturing license is issued on Form MD5.
Manufacturing License Documents Required
For your Medical Image Storage Device, the following documents are essential:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire Department No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (Refer our detailed Device Master File guide)
- Plant Master File (Comprehensive facility description; see our Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File (per ISO 14971 standards; learn more about risk management)
- Test Reports from approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (e.g., ISO 13485 certification)
Import License Process (MD15) for Medical Image Storage Devices
If you intend to import Medical Image Storage Devices into India, you must obtain an MD15 import license from the Central Licensing Authority. This process is more extensive and involves:
- Preparation of technical and regulatory documents
- Submission of application on Form MD14 through the CDSCO portal
- Resolution of departmental queries
- License issuance on Form MD15
Typical timelines range from 5 to 6 months. For detailed guidance, see our Import License Guide.
Import License Documents Required
Key documents include:
- Valid Manufacturing License (MD5 if manufactured in India)
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution Documents
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3-4 weeks |
| Document Preparation | Concurrent with testing |
| Application Review & Audit | 1 - 1.5 months |
| Query Resolution | 2 - 4 weeks |
| Total Estimated Time | 3 - 4 months |
Planning and early document preparation can significantly streamline this timeline.
Government Fees and Costs
For Class A Medical Image Storage Devices, the fee structure is as follows:
- Application Fee: Rs 5000 per application
- Product Fee: Rs 500 per product
Additional costs include fees for product testing, notified body audits, and consultancy services if engaged.
Common Challenges and Solutions
Challenge 1: Delays in Product Testing
- Solution: Engage with CDSCO-approved labs early and provide complete samples and documentation to avoid back-and-forth.
Challenge 2: Incomplete Documentation
- Solution: Use comprehensive checklists and experienced consultants to ensure all required files like Device Master File and Risk Management File are complete.
Challenge 3: Audit Non-Compliance
- Solution: Conduct internal audits and pre-audit readiness assessments to prepare your facility and QMS.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory officer to track and respond promptly to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, but with expert guidance, it can be a smooth process. We provide end-to-end support including:
- Documentation preparation
- Coordination with notified bodies and testing labs
- Application submission and follow-up
- Training for audit readiness
Our extensive experience with over 500 successful licenses ensures you avoid common pitfalls and achieve timely approval.
Getting Started with Your CDSCO License Application
Conduct a Gap Assessment: Evaluate your current documentation and facility readiness against CDSCO requirements.
Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal to obtain the test license.
Engage Testing Labs: Coordinate sample testing with approved labs promptly.
Prepare Documentation: Develop or update your Device Master File, Plant Master File, Risk Management File, and QMS documents.
Schedule Audit: Identify and appoint a notified body from the official list of notified bodies.
Submit Manufacturing License Application: Apply using Form MD3 through the CDSCO portal once testing and documents are ready.
Maintain Communication: Actively respond to any queries from CDSCO or auditors to avoid delays.
Embarking on this process with a structured plan and expert insights will help you successfully obtain your MD5 license for Medical Image Storage Devices, enabling your entry into India's dynamic healthcare market.
For personalized support and detailed assistance, feel free to reach out to our regulatory consulting team, who bring decades of expertise in CDSCO licensing across diverse medical devices.
