CDSCO License for Operation table system
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 system that consists of several components that form a complete surgical table system. It is used to replace tabletops, change the patient's position, and transfer the patient to and from the operating room. Usually, it consists of columns, a removable tabletop, remote controller for the trolley, and a trolley.
Comprehensive Guide to CDSCO Licensing for Operation Table Systems (Class A Medical Device)
Operation table systems are critical components of surgical infrastructure, enabling patient positioning and transfer during medical procedures. Given their pivotal role in patient safety and surgical efficacy, regulatory compliance with India’s Central Drugs Standard Control Organization (CDSCO) is essential. With over 25 years of experience assisting 500+ manufacturers and importers, we offer you a detailed roadmap to obtain the necessary CDSCO license for your Operation Table System, classified as a Class A medical device.
CDSCO Regulatory Framework for Operation Table Systems
As per the CDSCO medical device classification, Operation Table Systems fall under Class A (low risk), governed by the Drugs and Cosmetics Rules, 1945, and notified under File No. 29/Misc/03/2020-DC (199) dated 13.9.2021. This classification mandates obtaining an MD5 manufacturing license if you are a manufacturer or an MD15 import license if you plan to import.
The regulatory pathway ensures that your device meets safety, quality, and performance standards to protect patients and users. Compliance includes documentation, testing, audits, and adherence to the Essential Principles checklist.
Risk Classification and License Requirements for Operation Table Systems
- Device: Operation Table System
- Risk Class: Class A (Low Risk)
- Applicable License: MD5 Manufacturing License (Form MD3)
- Licensing Authority: State Licensing Authority
Class A devices like Operation Table Systems require a streamlined yet thorough approval process, emphasizing quality management systems, technical documentation, and product testing.
Manufacturing License Process for Operation Table Systems (MD5)
- Obtain Test License (Form MD13): Before manufacturing, you must secure a test license which authorizes pilot production and sample testing.
- Product Testing: Conduct tests at Government-approved laboratories to validate safety and performance. Refer to the list of testing laboratories for accredited centers.
- Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.
- License Application Submission: Apply online through the CDSCO MD Online Portal using Form MD3.
- Audit by Notified Body: Engage a notified body (see Notified Bodies List) for an on-site audit verifying compliance.
- Respond to Queries: Address any observations or queries raised by the audit team or CDSCO officials promptly.
- Grant of License: Upon satisfactory review, receive the MD5 license permitting manufacturing.
Manufacturing License Documents Required for Operation Table Systems
- Company Constitution (Incorporation Certificate, Partnership Deed)
- Proof of Ownership/Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Details
- Fire NOC and Pollution Control Board Clearance
- Device Master File detailing design, materials, and specifications (See Guide)
- Plant Master File outlining manufacturing processes and facility details (See Guide)
- Essential Principles Checklist ensuring compliance with safety and performance
- Risk Management File documenting hazard analysis and mitigation (Risk Management Insights)
- Test Reports from accredited labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents (preferably ISO 13485 compliant)
Import License Process for Operation Table Systems (MD15)
If you are importing Operation Table Systems, the MD15 import license issued by the Central Licensing Authority is mandatory. The process includes:
- Document Preparation: Compile documents including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and Wholesale License.
- Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
- Department Review: CDSCO reviews submitted documents and may raise queries.
- Grant of License: Upon clearance, you receive the MD15 license permitting import.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Process Steps | Estimated Duration |
|---|---|---|
| MD5 (Manufacturing) | Test License + Testing + Audit + License | 3 to 4 months total |
| MD15 (Import) | Document Submission + Review + License | 5 to 6 months total |
The test license (MD13) phase alone takes approximately 1.5 to 2 months. Testing turnaround depends on the chosen laboratory’s capacity.
Government Fees and Costs
- MD5 License Fees:
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
- MD13 Test License Fees: Typically included in the overall license fees but verify locally.
Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.
Common Challenges and Solutions
- Delayed Testing Results: Plan testing schedules well in advance and select labs with proven turnaround times.
- Incomplete Documentation: Use detailed checklists for Device Master File and Plant Master File preparation to avoid rejections.
- Audit Non-compliance: Conduct internal audits before notified body inspection to ensure readiness.
- Query Management: Respond promptly and comprehensively to queries raised by CDSCO to avoid delays.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for first-time applicants. Our consulting team, experienced in supporting over 500 companies, offers:
- Step-by-step application assistance
- Document preparation and review
- Coordination with notified bodies and testing labs
- Audit readiness training
- Query resolution support
Our expert guidance ensures your Operation Table System complies fully with Indian regulatory requirements, expediting market entry.
Getting Started with Your CDSCO License Application
- Assess Classification: Confirm your device as Class A and applicable license (MD5).
- Prepare Facility: Ensure your manufacturing site complies with GMP and has required clearances.
- Compile Documentation: Begin assembling the Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Apply for Test License (MD13): Submit application via the CDSCO MD Online Portal.
- Schedule Product Testing: Engage government-approved labs early to avoid bottlenecks.
- Engage Notified Body: Identify and coordinate with a notified body from the official list for your device audit.
- Submit MD5 License Application: Once test license and testing complete, apply for the manufacturing license.
- Prepare for Audit: Conduct mock audits and address any gaps.
- Monitor Application Status: Track progress on the CDSCO portal and respond to any queries swiftly.
By following these actionable steps and leveraging our decades of expertise, manufacturers can confidently and efficiently secure CDSCO approval for Operation Table Systems, ensuring timely access to the Indian healthcare market.
For detailed assistance, explore our comprehensive MD5 License Guide or contact our regulatory consultants today.
