CDSCO License for Gynaecological operating table, electrohydraulic or  electromechanical or hydraulic

Comprehensive Guide to CDSCO Licensing for Gynaecological Operating Tables (Class A Medical Device)

As specialists with over 25 years of experience in medical device regulatory affairs, we have successfully guided more than 500 companies through the complexities of obtaining CDSCO licenses in India. This guide focuses on the Gynaecological Operating Table—an active Class A device designed to support patients during gynecological surgical procedures—detailing the exact steps, timelines, documents, costs, and practical insights you need to enter the Indian market compliantly.

Understanding the Device and Regulatory Importance

The Gynaecological Operating Table, whether electrohydraulic, electromechanical, or hydraulic, falls under the Obstetrical and Gynecological device category. Classified as Class A (low risk) per the CDSCO classification, it is crucial to comply with Indian regulations to ensure patient safety and legal market access. The device is notified under File No. 29/Misc./03/2020-DC (181) dated 03.06.2022.

Non-compliance can lead to import/export restrictions, penalties, or product recalls. Therefore, obtaining the correct manufacturing or import license is essential.

CDSCO Regulatory Framework for Gynaecological Operating Tables

The Central Drugs Standard Control Organisation (CDSCO) regulates medical devices in India through a risk-based classification system. For Class A devices such as the Gynaecological Operating Table, the licensing authority is the State Licensing Authority, and the license type is MD5 (Manufacturing License).

Manufacturers must:

• Obtain a Test License (Form MD13) initially
• Conduct product testing at CDSCO-approved laboratories
• Submit the application for the MD5 license (Form MD3)
• Undergo an audit by a notified body
• Address queries from the authority before license approval

Importers require a separate MD15 license, but this guide focuses on manufacturing.

For an overview of device classification, you can refer to our Medical Device Classification guide.

Risk Classification and License Requirements for Class A Devices

The Gynaecological Operating Table's Class A status means:

• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority
• Audit: Conducted by a Notified Body listed on the CDSCO Notified Bodies List
• Testing: Required from CDSCO-recognized labs (see Testing Laboratories)
• Total Timeline: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

This regulatory framework ensures that the device meets quality, safety, and efficacy standards before marketing in India.

Manufacturing License Process for Gynaecological Operating Tables (MD5)

The MD5 license process is methodical and includes several critical steps:

1. Apply for Test License (Form MD13): Allows initial product testing; takes 1.5-2 months.
2. Product Testing: Conduct mandatory testing at CDSCO-approved laboratories.
3. Document Preparation: Compile technical and quality management documents.
4. Submit MD5 Application (Form MD3): File on the CDSCO MD Online Portal.
5. Notified Body Audit: A third-party audit validates the manufacturing process and quality systems.
6. Query Resolution: Address any queries raised by the department or auditors promptly.
7. Grant of MD5 License (Form MD5): Final approval enabling manufacturing and sale in India.

Our experience shows early preparation of documentation and proactive communication with notified bodies significantly reduce processing delays.

Manufacturing License Documents Required

For a smooth MD5 application specific to the Gynaecological Operating Table, prepare the following:

• Company Constitution and Incorporation Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing product specifications and design (Device Master File Guide)
• Plant Master File (PMF) describing manufacturing facilities (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File demonstrating hazard identification and mitigation (Risk Management)
• Test Reports from approved laboratories
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, preferably ISO 13485 compliant

Thorough and well-organized documentation expedites the audit and approval process.

Import License Process (MD15) Overview

While this guide primarily targets manufacturers, importers of Gynaecological Operating Tables must apply for an MD15 Import License through the central CDSCO licensing authority. This process generally takes 5-6 months and requires submission of documents like Manufacturer’s License, Free Sale Certificate, ISO 13485:2016 certification, CE Mark Certificate, and others.

You can explore more about the import license process in our detailed Import License Guide.

Timeline and Processing Duration

Timely submission and prompt query resolution can shave weeks off this timeline.

Government Fees and Costs

For the Gynaecological Operating Table (Class A device), the fee structure is:

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

Additional costs include:

• Testing fees at government-approved labs (variable, depending on tests required)
• Notified body audit fees (usually INR 50,000 to 1,00,000 depending on auditor)
• Consultancy or documentation preparation costs (if outsourced)

Budgeting for these expenses upfront avoids surprises during the licensing process.

Common Challenges and Solutions

• Incomplete Documentation: Detailed Device Master File and Risk Management File preparation is often overlooked. Using our comprehensive guides ensures completeness.
• Delays in Testing: Schedule product testing early and choose CDSCO-accredited labs from the Testing Laboratories list.
• Audit Non-compliance: Pre-audit internal reviews and checklists reduce the risk of non-conformities during notified body audits.
• Query Delays: Assign a dedicated regulatory contact to respond promptly to CDSCO queries.

Our hands-on experience has helped clients overcome these hurdles efficiently.

Expert Consultation and Support

Navigating CDSCO licensing for Class A devices like the Gynaecological Operating Table can be complex, but expert guidance simplifies the path. Our team offers:

• Customized regulatory strategy
• Document preparation and review
• Liaison with notified bodies and CDSCO authorities
• Training on regulatory compliance and QMS implementation

Leverage our 25+ years of expertise and proven track record to accelerate your market entry with confidence.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class A using official resources.
2. Prepare Test License Application (Form MD13): Initiate this on the CDSCO MD Online Portal.
3. Select CDSCO-Approved Testing Laboratory: Plan testing timelines.
4. Compile Detailed Documentation: Utilize Device and Plant Master File templates.
5. Schedule Audit with Notified Body: Choose from the list available on the CDSCO portal.
6. Submit MD5 Application (Form MD3): Post successful testing and audit preparation.
7. Monitor Application Status: Promptly respond to any queries.

Starting early and following a structured roadmap minimizes delays and ensures compliance.

By adhering to these steps and leveraging expert support, manufacturers of Gynaecological Operating Tables can successfully obtain their CDSCO MD5 license and establish a trusted presence in the Indian medical device market.