CDSCO License for General-purpose diagnosis/treatment 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 table for general diagnosis and procedures in examination room to aid in patient examination.
Introduction to General-Purpose Diagnosis/Treatment Table and Regulatory Importance
General-purpose diagnosis and treatment tables are fundamental equipment in operation theatres and examination rooms, facilitating patient examination and minor procedures. Classified under Class A medical devices, these tables are considered low-risk but critical for clinical workflows. Regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure safety, quality, and market access in India.
With over 25 years of experience assisting 500+ manufacturers and importers, we deeply understand the nuances of obtaining CDSCO licenses, specifically for Class A devices like diagnosis/treatment tables. This comprehensive guide provides practical insights, timelines, and cost structures to help you navigate the regulatory pathway efficiently.
CDSCO Regulatory Framework for General-Purpose Diagnosis/Treatment Tables
The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, amended periodically. Your device, categorized as Class A (low risk), falls under the jurisdiction of the State Licensing Authority for manufacturing licenses.
The official notification governing this device is File No. 29/Misc/03/2020-DC (199), dated 13.9.2021, which classifies it under operation theatre equipment and mandates compliance with specific safety and quality standards.
Risk Classification and License Requirements for Class A Devices
As a Class A device, the general-purpose diagnosis/treatment table requires the MD5 manufacturing license (Form MD3 for application). This license is granted by the State Licensing Authority and involves a structured process including test licensing, product testing, audit, and documentation verification.
For importers, an MD15 import license from the Central Licensing Authority is necessary. However, since this guide focuses primarily on manufacturing, we will elaborate on the MD5 process.
Manufacturing License Process (MD5) for Diagnosis/Treatment Tables
The MD5 license process typically spans 3 to 4 months and involves the following key steps:
Test License Application (Form MD13): Apply for a test license, which allows initial product testing and validation. This step usually takes 1.5 to 2 months.
Product Testing: Conduct product tests at CDSCO-approved government laboratories to ensure compliance with essential principles and standards. You can find the list of Testing Laboratories authorized for this purpose.
Document Preparation: Compile the required technical and quality documents including Device Master File, Plant Master File, risk management, and more.
License Application (Form MD3): Submit the MD5 license application via the CDSCO MD Online Portal along with supporting documents.
Audit by Notified Body: Undergo an audit conducted by a CDSCO notified body to verify manufacturing capabilities and quality systems. Refer to the list of notified bodies for audit assignments.
Query Resolution: Address any queries or deficiencies raised by either the licensing department or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory review and audit completion, the State Licensing Authority issues the MD5 manufacturing license.
Manufacturing License Documents Required for General-Purpose Diagnosis/Treatment Table
The documentation must be meticulously prepared to avoid delays. Essential documents include:
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement for Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Detailed Device Master File (DMF) outlining design, specifications, and intended use. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF) describing manufacturing facilities and quality controls. Learn more through our Plant Master File guide.
- Essential Principles Checklist confirming compliance with MDR requirements
- Risk Management File detailing hazard analysis and mitigation. See our Risk Management resource.
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as ISO 13485 certification, SOPs, and audit reports
Import License Process (MD15) for General-Purpose Diagnosis/Treatment Tables
Importers must obtain an MD15 license from the Central Licensing Authority, a process generally lasting 5 to 6 months. Although a test license is not mandatory, thorough documentation and compliance evidence are critical.
The application is submitted on the CDSCO MD Online Portal, with required documents including:
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution
Government fees vary based on risk class and number of products imported.
For detailed guidance on import licensing, refer to our Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Compilation | 3 - 4 weeks |
| License Application (MD3) | Immediate submission |
| Audit by Notified Body | 3 - 4 weeks |
| Query Resolution & Final Grant | 2 - 3 weeks |
Total Estimated Time: Approximately 3 to 4 months for the entire MD5 license process.
Government Fees and Costs for MD5 License
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs may include laboratory testing fees, audit fees charged by notified bodies, and consultancy fees if you engage expert services.
Common Challenges and Solutions
Challenge: Delays in test license approval or product testing.
Solution: Early submission of complete and accurate test license applications and preemptively selecting reputed testing laboratories can speed up the process.
Challenge: Incomplete or inconsistent documentation.
Solution: Use comprehensive templates and checklists for Device Master File and Plant Master File preparation. Our guides offer practical advice to avoid common pitfalls.
Challenge: Audit non-conformities.
Solution: Conduct internal pre-audits and gap assessments to ensure compliance with QMS and regulatory requirements before the notified body visit.
Challenge: Resolving department queries.
Solution: Maintain open communication with CDSCO officials and prepare prompt, well-supported responses.
Expert Consultation and Support
Navigating CDSCO regulations can be complex, especially for first-time applicants. With our 25+ years of experience and a track record of supporting over 500 companies, we provide end-to-end assistance—from documentation to audit preparation and query handling.
Engage our expert consultants to ensure your general-purpose diagnosis/treatment table obtains the MD5 license efficiently, minimizing rejections and delays.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your device’s Class A status using the official Medical Device Classification guidelines.
Prepare Technical Documentation: Begin compiling your Device Master File and Plant Master File with attention to detail.
Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.
Coordinate Product Testing: Engage CDSCO-approved testing laboratories early to schedule sample testing.
Plan for Audit: Schedule your notified body audit after product testing and documentation readiness.
Submit MD5 License Application: Once test reports and audit clearance are ready, file Form MD3 online.
Monitor Application Status: Respond quickly to any CDSCO queries to avoid delays.
By following these structured steps with professional guidance, your pathway to market for the general-purpose diagnosis/treatment table can be smooth and compliant.
For personalized support and to discuss your specific product licensing needs, contact our expert regulatory consultants today.
