CDSCO License for Patient positioning device for whole body diagnostic imaging and radiotherapy
Medical Device Information
Intended Use
A device that consists of fixed or adjustable parts (e.g., frames and plates), and is specifically designed to properly position and fix the patient's whole body for image diagnosis, image-guided surgery, interventional therapy, or radiotherapy.

Patient Positioning Device for Whole Body Diagnostic Imaging and Radiotherapy: Regulatory Overview and CDSCO Licensing
Patient positioning devices designed for whole body diagnostic imaging and radiotherapy are critical medical devices ensuring accurate imaging and effective treatment delivery. These devices, consisting of frames and plates that fix the patient’s position, play a vital role in image-guided surgery, interventional therapy, and radiotherapy procedures. Given their importance and moderate risk profile, regulatory compliance with the Central Drugs Standard Control Organisation (CDSCO) in India is mandatory to ensure safety and performance.
With over 25 years of experience assisting more than 500 medical device companies, we provide you with a detailed roadmap to obtain the required CDSCO license for your Patient Positioning Device, classified under Risk Class B with notification File No. 29/Misc./03/2020-DC (180) dated 6.8.2021.
CDSCO Regulatory Framework for Patient Positioning Devices
In India, medical devices are regulated under the Medical Device Rules (MDR) 2017 notified by CDSCO, which oversee the manufacture, import, and sale of medical devices. Patient positioning devices used in radiotherapy fall under the category of Class B devices, defined as low to moderate risk.
The regulatory framework mandates obtaining a manufacturing license (MD5) from the State Licensing Authority before production and marketing. Key steps include test license acquisition, product testing at government-approved laboratories, audit by notified bodies, and compliance with quality management systems.
Risk Classification and License Requirements for Class B Devices
According to CDSCO’s classification, your Patient Positioning Device is Class B due to its intended use in radiotherapy and diagnostic imaging, posing moderate risk to patients if malfunctioning. For Class B devices:
- License Type: MD5 Manufacturing License
- Authority: State Licensing Authority
- Application Form: MD3
- Process Duration: Approximately 3 to 4 months
- Fees: Rs. 5,000 per application + Rs. 500 per product
Refer to the detailed Medical Device Classification guide for further clarity.
Manufacturing License Process (MD5) for Patient Positioning Devices
The MD5 license process is multipart and requires diligent preparation:
- Test License (Form MD13): Must be obtained first to enable product testing. This takes about 1.5 to 2 months.
- Product Testing: Testing must be carried out at CDSCO-recognized laboratories to ensure compliance with essential principles and safety standards. Explore the list of approved testing laboratories.
- Documentation Preparation: Compile necessary documents including Device Master File, Plant Master File, and Risk Management File.
- Application Submission: Submit Form MD3 via the CDSCO MD Online Portal.
- Audit by Notified Body: An audit is conducted to verify manufacturing capabilities and quality systems. Check the notified bodies list for approved auditors.
- Query Resolution: Respond promptly to any queries from CDSCO or the notified body.
- License Grant: Upon successful audit and document verification, the MD5 license is issued.
Detailed guidance on the MD5 license process is available in our MD5 License Guide.
Manufacturing License Documents Required
For your Patient Positioning Device, the following documents must be prepared meticulously:
- Company Constitution (Incorporation Certificate)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualifications and Experience Details of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications and design controls (see our Device Master File Guide)
- Plant Master File describing manufacturing facilities and quality controls (refer to our Plant Master File Guide)
- Essential Principles Checklist confirming compliance with MDR requirements
- Risk Management File demonstrating risk assessment and mitigation strategies (learn more about Risk Management)
- Test Reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU) complying with Indian regulations
- Quality Management System (QMS) Documents, typically ISO 13485:2016 certified
Ensuring completeness and accuracy of these documents greatly expedites the approval process.
Import License Process (MD15) for Patient Positioning Devices
If you plan to import this device into India, an Import License (MD15) granted by the Central Licensing Authority is mandatory. The process differs slightly:
- Application Form: MD14
- No Test License Required: Testing and audit requirements differ from manufacturing
- Documentation: Includes Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016 Certification, CE Certificate, Device and Plant Master Files, Wholesale License, and Company Constitution.
- Fees: Vary by risk class; for Class B devices, around Rs. 2,000 per site + Rs. 1,000 per product
- Processing Time: Approximately 5 to 6 months
Detailed steps are outlined in our Import License Guide.
Import License Documents Required
Key documents for MD15 license include:
- Valid Manufacturing License for the device
- Free Sale Certificate from manufacturing country
- ISO 13485:2016 Quality Management Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License (if applicable)
- Company Constitution and Importer details
Preparing these in advance reduces back-and-forth queries and accelerates approval.
Timeline and Processing Duration
License Type | Steps Involved | Approximate Duration |
---|---|---|
MD5 (Manufacturing) | Test license, product testing, audit | 3 to 4 months |
MD15 (Import) | Document verification, queries | 5 to 6 months |
Test license acquisition and product testing are critical and often time-consuming phases. Starting documentation early and engaging notified bodies promptly can help compress timelines.
Government Fees and Costs
- MD5 License: Rs. 5,000 per application + Rs. 500 per product
- MD15 Import License: For Class B devices, Rs. 2,000 per site + Rs. 1,000 per product
Additional costs may include audit fees, testing charges at government labs, and consultancy fees where applicable. Budgeting realistically for all is essential for seamless licensing.
Common Challenges and Practical Solutions
- Delay in Product Testing: Coordinate early with approved labs and submit samples promptly.
- Incomplete Documentation: Use checklists and professional help to avoid omissions.
- Audit Non-compliance: Conduct internal pre-audits and ensure QMS adherence before notified body visits.
- Query Resolution Delays: Assign dedicated teams for prompt, accurate responses to CDSCO queries.
Our experience working with 500+ companies enables us to anticipate and mitigate these challenges effectively.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for specialized devices like patient positioning aids in radiotherapy. Our expert consultants provide:
- Comprehensive gap analysis of your documentation
- Coordination with notified bodies and testing labs
- End-to-end application handling on the CDSCO MD Online Portal
- Training on regulatory requirements and compliance
Engaging with seasoned professionals reduces risks and accelerates market entry.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm Class B status as per CDSCO MDR.
- Prepare Test License Application (Form MD13): Gather initial documents and submit via the CDSCO MD Online Portal.
- Plan Product Testing: Contact CDSCO-approved laboratories early.
- Compile Full Documentation: Start assembling Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Identify Notified Body: Schedule your audit by selecting from the list of notified bodies.
- Submit Manufacturing License Application (Form MD3): Post successful testing and internal readiness.
- Prepare for Audit and Queries: Conduct mock audits and assign query resolution teams.
By following these targeted steps and leveraging our 25+ years of expertise, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring timely approval and successful market access for your Patient Positioning Device.
For personalized assistance and detailed regulatory strategy, feel free to connect with our consultants.