CDSCO License for Gynaecological operating table top

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

As specialists with over 25 years of experience in the Indian medical device regulatory landscape, we understand the intricacies involved in obtaining CDSCO licenses, especially for Class A devices like the Gynaecological Operating Table Top. This device, a detachable modular component used in gynecological surgical procedures, falls under the Obstetrical and Gynecological category and is classified as a low-risk Class A medical device by the Central Drugs Standard Control Organization (CDSCO).

CDSCO Regulatory Framework for Gynaecological Operating Table Tops

The regulatory oversight for medical devices in India is governed by the Medical Device Rules (MDR) 2017, with CDSCO acting as the central authority. Your device, notified under File No. 29/Misc./03/2020-DC (181) dated 03.06.2022, requires compliance with these rules to ensure market access.

CDSCO classifies medical devices into four risk classes (A, B, C, D), with Class A being the lowest risk. For your device, this means licensing is managed primarily by the State Licensing Authority through the MD5 manufacturing license.

Risk Classification and License Requirements for Class A Devices

Class A devices like the Gynaecological Operating Table Top require an MD5 license for manufacturing within India. This involves:

• Obtaining a Test License (Form MD13) initially
• Product testing from government-approved laboratories
• Submission of comprehensive documentation
• Audit by a notified body
• Final grant of the MD5 license (Form MD5)

For importers, an MD15 import license is required, but as a manufacturer, your focus is on the MD5.

Step-by-Step Manufacturing License Process (MD5)

1. Apply for Test License (MD13): Before full-scale manufacturing, apply for a test license via the CDSCO MD Online Portal. The test license is valid for 3-6 months and allows for product testing.
2. Product Testing: Conduct mandatory product testing at government-recognized testing laboratories. This ensures compliance with applicable standards.
3. Documentation Preparation: Collate technical, quality management, and compliance documents.
4. Application Submission for MD5 (Form MD3): Apply for the manufacturing license through the CDSCO MD Online Portal, submitting all required documents.
5. Audit by Notified Body: The notified body will conduct a factory audit to verify compliance. Check the list of notified bodies to select an authorized auditor.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. Grant of License (MD5): Upon successful audit and query clearance, the manufacturing license is granted.

Essential Documents for MD5 License Application

For a Class A device like the Gynaecological Operating Table Top, prepare the following documentation:

• Company Constitution: Proof of legal entity
• Proof of Premises Ownership or Lease: Valid property documents
• Technical Staff Details: Qualifications and experience certificates
• Fire and Pollution NOCs: Safety compliance certificates
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process (see our Device Master File guide)
• Plant Master File (PMF): Information on manufacturing facilities (refer to our Plant Master File guide)
• Essential Principles Checklist: Compliance with Indian medical device standards
• Risk Management File: Risk assessment and mitigation plans (insights in our Risk Management guide)
• Test Reports: From approved laboratories
• Product Labels and Instructions for Use (IFU): Labeling compliance
• Quality Management System (QMS) Documents: ISO 13485 certification and internal policies

Import License Process (MD15) for Gynaecological Operating Table Tops

If you plan to import this device, the MD15 import license is mandatory. Key highlights:

• Application: Submit Form MD14 via the CDSCO MD Online Portal
• Documents: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale license, and Company Constitution
• Fees: Vary based on device risk class; for Class A, approximately $1000 per site plus$50 per product
• Processing Time: Typically 5-6 months

For detailed guidance, see our Import License guide.

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months depending on lab capacity
• Audit and Documentation Review: 1 to 1.5 months
• Final License Grant (MD5): Overall 3 to 4 months

Being proactive with documentation and audit readiness can significantly reduce delays.

Government Fees and Associated Costs

• Test License (MD13): Approximately Rs 5000
• Manufacturing License (MD5): Rs 5000 application fee plus Rs 500 per product
• Testing Fees: Variable based on the testing laboratory and number of product variants
• Audit Fees: Payable to notified bodies as per their rates

Budgeting for these costs upfront ensures smooth project planning.

Common Challenges and Practical Solutions

• Incomplete Documentation: Maintain a detailed checklist and cross-verify documents before submission.
• Delayed Testing: Schedule tests early and choose government-approved labs from the Testing Laboratories list.
• Audit Non-compliance: Conduct internal mock audits and training prior to notified body inspections.
• Query Response Delays: Assign a dedicated regulatory liaison to monitor and respond promptly.

Expert Consultation and Support

With experience assisting over 500 companies, we offer end-to-end support from pre-application consultation to post-license compliance. Our tailored approach ensures your Gynaecological Operating Table Top meets all CDSCO requirements efficiently.

Getting Started with Your CDSCO License Application

1. Assess Device Classification: Confirm your device is Class A using the Medical Device Classification resource.
2. Register on CDSCO MD Online Portal: Create your account to access application forms and track progress.
3. Prepare Test License Application: Gather required documents and apply for Form MD13.
4. Engage Approved Testing Laboratory: Book testing slots early to avoid bottlenecks.
5. Compile Complete Documentation: Use our guides for Device Master File and Plant Master File preparation.
6. Schedule Notified Body Audit: Choose from the list of notified bodies and plan the audit.
7. Submit MD5 Application: Once testing and audit are complete, apply on the portal with all supporting documents.
8. Monitor Application Status: Respond promptly to any queries to expedite approval.

Embarking on the CDSCO licensing journey with a clear roadmap reduces uncertainty and accelerates your market entry. Partner with us to leverage our deep regulatory expertise and make your Gynaecological Operating Table Top available to healthcare providers across India.

For personalized guidance, reach out to our regulatory specialists today and take the first step towards compliance and success.