CDSCO License for Radiologic table
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 radiologic table is a device intended for medical purposes to support a patient during radiologic procedures. The table may be fixed or tilting and may be electrically powered.
Comprehensive Guide to CDSCO Licensing for Radiologic Tables (Class A Medical Device)
Radiologic tables are indispensable devices in interventional radiology, designed to support patients during radiologic procedures such as X-rays and fluoroscopy. These tables, which may be fixed or tilting and electrically powered, require stringent regulatory compliance to ensure safety and efficacy. Given their classification as Class A devices under the Indian CDSCO framework, obtaining the appropriate manufacturing or import license is critical for market access.
With over 25 years of experience and having assisted more than 500 companies in securing CDSCO licenses, we provide you with a detailed roadmap to navigate the regulatory landscape specific to Radiologic Tables.
CDSCO Regulatory Framework for Radiologic Tables
The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Radiologic tables fall under the interventional radiology category and are notified under Notification 29/Misc./03/2020-DC (146) dated 26.07.2021. As a Class A device, they are considered low risk but still require compliance with the Medical Device Rules, 2017.
Manufacturing licenses for Class A devices are issued by State Licensing Authorities, whereas import licenses fall under the jurisdiction of the Central Licensing Authority.
Risk Classification and License Requirements for Radiologic Tables
Radiologic tables are classified as Class A (low risk) medical devices. This classification simplifies certain regulatory requirements but does not exempt manufacturers or importers from stringent compliance.
| License Type | Regulatory Authority | Application Form | Typical Processing Time | Govt Fees |
|---|---|---|---|---|
| Manufacturing (MD5) | State Licensing Authority | MD3 | 3-4 months | Rs 5000 + Rs 500 per product |
| Import (MD15) | Central Licensing Authority | MD14 | 5-6 months | Rs 1000 per site + Rs 50 per product |
Manufacturers of radiologic tables must apply for an MD5 license, while importers require an MD15 import license.
Manufacturing License Process for Radiologic Tables (MD5 License)
- Test License Application (Form MD13):
- Apply for a test license to manufacture the radiologic table prototype.
- Processing time: Approximately 1.5 to 2 months.
- Product Testing:
- Submit product samples to government-approved testing laboratories.
- Reference the list of testing laboratories for authorized facilities.
- Document Preparation:
- Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- License Application (Form MD3):
- Submit the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body:
- Coordinate audit by an approved notified body. For a list of notified bodies, see Notified Bodies List.
- Resolution of Queries:
- Address any queries raised by the department or notified body promptly.
- Grant of License (Form MD5):
- Upon successful audit and document review, the license is granted.
Manufacturing License Documents Required for Radiologic Tables
- Company constitution documents
- Proof of ownership or lease agreement of manufacturing premises
- Qualifications and experience details of technical staff
- Fire and pollution NOCs
- Device Master File (DMF) – see our Device Master File guide
- Plant Master File (PMF) – detailed manufacturing process info; refer to our Plant Master File guide
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File highlighting hazard analysis and mitigation strategies
- Product test reports from government-approved labs
- Labeling and Instructions for Use (IFU) compliant with CDSCO guidelines
- Quality Management System (QMS) documentation, preferably ISO 13485 certified
Import License Process for Radiologic Tables (MD15 License)
Importers of radiologic tables must obtain an MD15 license from the Central Licensing Authority. The process includes:
- Document Preparation:
- Compile required documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate, DMF and PMF, and wholesale license.
- Application Submission:
- Submit the application on the CDSCO MD Online Portal using Form MD14.
- Queries Resolution:
- Respond to any departmental queries promptly to avoid delays.
- License Grant:
- Upon satisfactory review, the import license is issued on Form MD15.
Import License Documents Required
- Valid manufacturing license from the exporting country
- Free Sale Certificate confirming product marketability abroad
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license issued by the State Authority
- Company constitution and address proof
Timeline and Processing Duration
| License Type | Total Processing Time |
|---|---|
| MD5 Manufacturing | 3-4 months (includes test license, testing, audit) |
| MD15 Import | 5-6 months |
Manufacturers should anticipate approximately 1.5-2 months for the test license and product testing. Audit scheduling and query resolution can affect overall timelines.
Government Fees and Costs
- MD5 Manufacturing License: Rs 5,000 per application + Rs 500 per product
- MD15 Import License: Rs 1,000 per site + Rs 50 per product (for Class A devices)
Additional costs may include fees for testing at government-approved labs and notified body audit fees.
Common Challenges and Solutions
- Delay in Testing: Testing laboratories often have backlogs. Plan submission well in advance and select labs strategically.
- Incomplete Documentation: Ensure all documents, especially DMF and PMF, are detailed and compliant; leverage expert consultants for accuracy.
- Audit Non-compliance: Conduct internal audits prior to notified body visits to identify gaps.
- Query Resolution Delays: Set up a dedicated regulatory liaison to respond swiftly to CDSCO queries.
Expert Consultation and Support
Our team has guided over 500 manufacturers and importers through the CDSCO licensing process. We offer:
- Document preparation assistance tailored for radiologic tables
- Pre-audit readiness assessments
- Liaison with notified bodies and testing labs
- Strategic planning to optimize timelines and costs
Getting Started with Your CDSCO License Application for Radiologic Tables
- Evaluate Your Product Classification: Confirm your device’s Class A status using the Medical Device Classification resource.
- Obtain Test License: Submit Form MD13 for test manufacturing license via the CDSCO MD Online Portal.
- Arrange Product Testing: Coordinate with government-approved labs early to minimize delays.
- Prepare Comprehensive Documentation: Utilize our guides on Device Master File and Plant Master File to ensure compliance.
- Engage a Notified Body: Schedule audits and prepare for compliance inspections.
- Submit License Application: Complete and submit Form MD3 through the CDSCO portal.
- Respond to Queries Promptly: Assign a dedicated team member to manage communications with CDSCO.
By following these steps and leveraging expert support, manufacturers and importers can successfully navigate the regulatory requirements to bring radiologic tables to the Indian market efficiently and compliantly.
For detailed guidance or to initiate your CDSCO license application, contact our regulatory specialists today.
