CDSCO License for Manual operating table and accessories and manual operating chair and accessories

Comprehensive Guide to CDSCO Licensing for Manual Operating Tables and Chairs (Class A Medical Devices)

Manual operating tables and chairs, along with their accessories, play a vital role in dermatological and plastic surgery procedures by providing essential patient support during diagnostics and surgeries. As non-powered devices with movable components, these fall under Class A risk classification according to CDSCO regulations, requiring a specialized licensing process to ensure compliance and market entry in India.

With over 25 years of experience assisting more than 500 companies in securing CDSCO approvals, we provide you with an expert roadmap tailored specifically for manual operating tables and chairs, covering regulatory frameworks, license application procedures, timelines, costs, and practical tips.

CDSCO Regulatory Framework for Manual Operating Tables and Chairs

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India. Manual operating tables and chairs are categorized under the Dermatological & Plastic Surgery device category, notified by Notification No. 29/Misc./03/2020-DC (147) dated 26.7.2021. These devices are non-powered and fall under Class A, which is the lowest risk class.

Compliance with the Medical Device Rules, 2017, enforced by CDSCO, is mandatory before manufacturing or importing these devices into the Indian market. The licensing authority for Class A devices is the State Licensing Authority.

Risk Classification and License Requirements

Manual operating tables and chairs are classified as Class A devices based on their risk profile. This classification implies minimal risk to patients and users. Accordingly, the applicable manufacturing license is the MD5 license (Form MD3 for application), granted by the State Licensing Authority.

Key points about Class A devices:

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License
• Licensing Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

Manufacturing License Process for MD5

The MD5 license process for manual operating tables and chairs comprises several sequential steps:

1. Test License (Form MD13): Before the manufacturing license, a test license is mandatory. This takes about 1.5 to 2 months to obtain and allows you to conduct product testing.

2. Product Testing: Conduct product testing at government-approved laboratories. Testing ensures compliance with relevant Indian standards and essential principles.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Application Submission: Submit the manufacturing license application on the CDSCO MD Online Portal using Form MD3.

5. Audit by Notified Body: The manufacturing facility undergoes an audit by a notified body from the official list of notified bodies.

6. Resolution of Queries: Address any queries or observations raised by the licensing authority or notified body.

7. License Grant: Upon satisfactory compliance, the license is granted in Form MD5.

Manufacturing License Documents Required

To streamline your application for manual operating tables and chairs, ensure you have the following documents ready:

• Company Constitution (Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and qualifications of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device design, specifications, and manufacturing process (See our Device Master File Guide)
• Plant Master File (PMF): Description of the manufacturing facility and quality systems (Refer to our Plant Master File Guide)
• Essential Principles Checklist demonstrating compliance with safety and performance requirements
• Risk Management File showing hazard analysis and mitigation strategies (Learn about Risk Management)
• Test Reports from approved laboratories (Check Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System documents compliant with ISO 13485:2016

Import License Process (MD15) for Manual Operating Tables and Chairs

If you are an importer rather than a manufacturer, you must obtain the MD15 import license issued by the Central Licensing Authority. The process generally takes 5-6 months and involves:

• Document compilation including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale License
• Submission of application on the CDSCO MD Online Portal
• Resolution of departmental queries
• License grant on Form MD15

Costs vary by device class; for Class A devices, fees are $1000 per site and$50 per product.

Timeline and Processing Duration

For manual operating tables and chairs (Class A), expect the following timeline:

• Test License (MD13): 1.5 - 2 months
• Product Testing: 2 - 3 weeks (depends on lab workload)
• Document Preparation: Concurrent with testing (2 - 4 weeks)
• Application Submission and Processing: 1 - 1.5 months
• Audit and Query Resolution: 3 - 4 weeks

Overall, the end-to-end process for obtaining an MD5 manufacturing license typically takes 3 to 4 months.

Government Fees and Costs

The fee structure for MD5 licensing for Class A devices is as follows:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

Additional costs include testing charges at government-approved labs and audit fees payable to notified bodies, which vary based on scope.

Common Challenges and Practical Solutions

1. Document Gaps and Non-Compliance

Many manufacturers struggle with preparing comprehensive Device and Plant Master Files or risk management documentation. We recommend engaging experienced consultants early to avoid delays.

2. Testing Delays

Testing lab backlogs can extend timelines. Booking slots early with government-approved labs is crucial.

3. Audit Readiness

Ensure your facility and QMS are audit-ready before the notified body visit. Conduct internal mock audits to identify gaps.

4. Regulatory Updates

Stay updated with CDSCO notifications, especially changes in device classification or documentation requirements.

Expert Consultation and Support

Given the complexity and regulatory nuances, partnering with a seasoned regulatory consultant can significantly smooth your licensing journey. Our expertise spans over 25 years and 500+ successful CDSCO license grants, ensuring you avoid common pitfalls and expedite approvals.

We assist with:

• Documentation preparation and gap analysis
• Liaison with notified bodies and CDSCO officials
• Audit preparation and compliance training
• Test license and product testing coordination

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your manual operating table and chair fall under Class A per the Medical Device Classification guidelines.

2. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal to obtain the test license.

3. Plan Product Testing: Schedule testing with an approved laboratory early to align with your test license validity.

4. Compile Required Documents: Prepare your Device Master File, Plant Master File, Risk Management File, and all other required documents meticulously.

5. Engage a Notified Body: Select and coordinate with a notified body from the official list for your audit.

6. Submit Manufacturing License Application: Once testing and documentation are complete, apply using Form MD3 on the CDSCO portal.

7. Prepare for Audit and Queries: Conduct internal audits, train staff, and prepare for the notified body visit. Respond promptly to any queries.

By following these practical steps and leveraging expert support, manufacturers and importers of manual operating tables and chairs can confidently navigate the CDSCO licensing process and successfully enter the Indian medical device market.

For tailored assistance and end-to-end regulatory support, contact our consultancy team with 25+ years of proven expertise in CDSCO licensing.

Empower your medical device business with compliance and confidence — navigate your CDSCO licensing journey smoothly with our expert guidance.