CDSCO License for Ophthalmic operating table top

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

As specialists with over 25 years of experience in Indian medical device regulatory affairs, we understand the complex journey manufacturers and importers face when entering the Indian market. The ophthalmic operating table top, a critical component designed to support and stabilize the patient's head during ophthalmic surgeries, falls under Class A risk classification according to the CDSCO notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

This guide offers an expert, step-by-step approach to obtaining your CDSCO license, ensuring a smooth and compliant pathway to market.

CDSCO Regulatory Framework for Ophthalmic Operating Table Tops

In India, the Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. Ophthalmic operating table tops are classified as Class A devices, indicating a low-risk profile. This classification influences the licensing process, authority involved, and compliance requirements.

The device, intended as a modular table component to optimize surgical access by stabilizing the patient’s head, must meet essential safety and performance standards. Compliance ensures patient safety and surgeon efficacy during ophthalmic interventions.

Risk Classification and License Requirements

Under the CDSCO framework, medical devices are classified from Class A (low risk) to Class D (high risk). Ophthalmic operating table tops are Class A devices due to their intended function and risk profile.

• Class A devices require an MD5 manufacturing license granted by the State Licensing Authority.
• The license application process includes obtaining a test license (MD13), product testing in government-approved labs, documentation submission, and audit by a notified body.

Understanding this classification is crucial. For detailed classification guidance, refer to our Medical Device Classification resource.

Manufacturing License Process (MD5) for Ophthalmic Operating Table Tops

Step 1: Obtain Test License (Form MD13)

Before applying for the MD5 license, manufacturers must secure a test license to allow sample testing. This process takes approximately 1.5 to 2 months.

Step 2: Product Testing

Samples must be tested in CDSCO-approved laboratories to validate compliance with applicable standards. You can find a list of such labs on the CDSCO Testing Laboratories portal.

Step 3: Documentation Preparation

Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and others detailed below.

Step 4: Application Submission (Form MD3)

Submit your application for the MD5 manufacturing license through the CDSCO MD Online Portal. This initiates the review and audit process.

Step 5: Audit by Notified Body

A notified body will conduct an audit of your manufacturing facility and QMS compliance. The notified bodies list is accessible here.

Step 6: Query Resolution and License Grant

Respond promptly to any queries raised by CDSCO or the notified body. After satisfactory review, the license is granted on Form MD5.

For an in-depth understanding, consult our MD5 License Guide.

Manufacturing License Documents Required for Ophthalmic Operating Table Tops

To ensure a successful application, prepare the following documents meticulously:

• Company Constitution (Certificate of Incorporation, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Personnel
• Fire Safety NOC
• Pollution Control Board NOC
• Device Master File (DMF): Detailing device design, components, and specifications. Review our Device Master File Guide
• Plant Master File (PMF): Information about manufacturing processes and quality control. Our Plant Master File Guide is a valuable resource.
• Essential Principles Checklist to confirm compliance with CDSCO guidelines
• Risk Management File: Demonstrating risk analysis and mitigation strategies. Learn more about Risk Management.
• Product Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU) samples
• Quality Management System (QMS) Documents (e.g., ISO 13485:2016 certification)

Attention to detail in documentation expedites the review process and minimizes the risk of delays.

Import License Process (MD15) for Ophthalmic Operating Table Tops

Though your device is Class A and primarily subject to manufacturing licensing, importers must obtain an MD15 import license to legally bring the device into India.

Key Steps:

• Prepare requisite import documentation (similar to the manufacturing license, plus import-specific certificates like Free Sale Certificate, CE Certificate, and ISO 13485:2016).
• Submit application on the CDSCO MD Online Portal.
• Address any regulatory queries during the 5-6 month processing timeline.

For detailed guidance, visit our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate issued by the regulatory authority
• ISO 13485:2016 Certification
• CE Certificate or equivalent quality assurance certificates
• Device Master File and Plant Master File
• Wholesale license for distribution
• Company Constitution documents

Being thorough here prevents costly delays at customs and regulatory checkpoints.

Timeline and Processing Duration

Planning your project timeline with these durations in mind is essential to avoid market entry delays.

Government Fees and Costs

Note: Fees are subject to change per CDSCO notifications. Budgeting accurately for these fees helps maintain cash flow.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or inadequate QMS.

• Solution: Engage early with experienced consultants, use checklists, and conduct internal audits to ensure readiness.

Challenge: Difficulty navigating the online application portal.

• Solution: Familiarize yourself with the CDSCO MD Online Portal and consider professional support for submission.

Challenge: Product testing failures or extended lab test times.

• Solution: Pre-assessment of product compliance and selecting efficient CDSCO-approved labs can mitigate risks. Refer to the Testing Laboratories list.

Challenge: Audit non-conformities.

• Solution: Prepare robust Plant and Device Master Files and QMS documentation. Conduct mock audits to identify gaps.

Expert Consultation and Support

Having supported over 500 companies in CDSCO licensing, we provide tailored consulting services including:

• Gap analysis of your current compliance status
• Comprehensive document preparation and review
• Liaison with notified bodies and CDSCO authorities
• Training for your technical and regulatory teams

Our proactive approach minimizes back-and-forth and accelerates your licensing timeline.

Getting Started with Your CDSCO License Application for Ophthalmic Operating Table Tops

1. Assess Device Classification: Confirm your device as Class A under the latest CDSCO notifications.
2. Initiate Test License Application: Prepare and submit Form MD13 on the CDSCO MD Online Portal.
3. Engage Approved Testing Laboratories: Coordinate early with labs to schedule product testing.
4. Gather and Organize Documentation: Utilize our Device Master File and Plant Master File guides as templates.
5. Plan for Audit: Schedule your notified body audit and prepare your facility accordingly.
6. Submit MD5 Application (Form MD3): Once testing and documentation are complete.
7. Address Queries Promptly: Maintain open communication with CDSCO and the notified body to resolve any issues quickly.

Starting early and following these practical steps can significantly reduce your time to market and ensure compliance with Indian regulations for ophthalmic operating table tops.

For personalized support and detailed roadmap, contact our regulatory experts today and leverage our 25+ years of experience to streamline your CDSCO licensing journey.