CDSCO License for Bagolini lens

Comprehensive Guide to CDSCO Licensing for Bagolini Lens (Class A Ophthalmic Device)

As a specialized ophthalmic plane lens designed to determine harmonious or anomalous retinal correspondence, the Bagolini lens plays a crucial role in vision diagnostics. Given its classification as a Class A medical device under Indian regulations and notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, securing the appropriate CDSCO license is essential for legal manufacturing and marketing in India. With over 25 years of experience and having supported 500+ companies, we provide you with a detailed, practical roadmap tailored for this device.

Understanding the CDSCO Regulatory Framework for Bagolini Lens

The Central Drugs Standard Control Organization (CDSCO) oversees medical device regulation in India. The Bagolini lens, categorized under ophthalmology, falls under Class A (low risk) devices. This classification means the licensing authority is the State Licensing Authority, and the relevant manufacturing license is the MD5 license (application form MD3).

Risk Classification and License Requirements for Bagolini Lens

• Risk Class: A (Low risk)
• Applicable License: MD5 (Manufacturing License for Class A/B devices)
• Regulatory Authority: State Licensing Authority
• Notification Reference: Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021

For a detailed understanding of medical device classifications, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5) for Bagolini Lens

The MD5 license process is systematic, involving several key steps:

1. Test License (Form MD13): Initially, you must apply for a test license which allows you to manufacture the device for testing purposes. This is mandatory before applying for the MD5 license.
2. Product Testing: The Bagolini lens must be tested in government-approved laboratories to validate compliance with Indian standards. Testing labs are listed on the CDSCO Testing Laboratories page.
3. Document Preparation: Prepare all required documentation including Device Master File and Plant Master File.
4. Application Submission: Submit the MD5 license application on the CDSCO MD Online Portal.
5. Audit by Notified Body: The manufacturing site undergoes an audit by a notified body from the official list.
6. Resolution of Queries: Address any observations raised during the audit or by the licensing authority.
7. Grant of License: Once all criteria are met, the MD5 license is issued.

Manufacturing License Documents Required for Bagolini Lens

To ensure a smooth licensing process, prepare the following documents meticulously:

• Company Constitution Documents: Memorandum & Articles of Association or equivalent
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualification and Experience Details
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed product specifications, design, manufacturing processes. Refer to our in-depth Device Master File guide.
• Plant Master File (PMF): Manufacturing facility details, equipment, quality control processes. Learn how to create one with our Plant Master File guide.
• Essential Principles Checklist: Compliance with Indian medical device essential principles.
• Risk Management File: Risk analysis and mitigation related to the Bagolini lens. Guidance available in our Risk Management guide.
• Test Reports: From CDSCO-approved testing laboratories.
• Labels and Instructions for Use (IFU): In compliance with CDSCO norms.
• Quality Management System (QMS) Documents: Evidence of ISO 13485 certification or equivalent quality processes.

Import License Process (MD15) for Bagolini Lens

If you plan to import the Bagolini lens instead of manufacturing it locally, you need to acquire an Import License (Form MD14 for application, MD15 for license). This is granted by the Central Licensing Authority and typically takes 5-6 months.

Documents required for import license include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate or equivalent international certification
• Device Master File and Plant Master File
• Wholesale Drug License (for importers/distributors)
• Company Constitution documents

You can find a practical guide for the import license application on our Import License Guide.

Timeline and Processing Duration for Bagolini Lens CDSCO Licensing

Government Fees and Costs

• Test License (MD13): Included in overall process costs
• MD5 Application Fee: ₹5,000 per application
• Per Product Fee: ₹500 per product

Costs may vary slightly depending on the notified body and testing laboratory fees. It’s advisable to budget for these additional expenses.

Common Challenges and Solutions

• Delays in Testing: Limited availability of slots in government-approved labs can delay testing. We recommend booking your testing dates well in advance.
• Documentation Gaps: Incomplete Device Master File or Plant Master File is a frequent cause of audit observations. Utilize templates and professional support to ensure completeness.
• Audit Non-compliance: Non-conformities during the notified body audit can lead to rejection. Conduct internal audits and mock inspections beforehand.
• Query Resolution Delays: Promptly addressing CDSCO queries with comprehensive evidence expedites license grant.

Expert Consultation and Support

Navigating CDSCO licensing regulations can be complex, especially for niche devices like the Bagolini lens. Our team brings over 25 years of collective expertise, having successfully guided 500+ manufacturers through the entire process—from documentation to final approval. We offer tailored support including:

• Gap analysis of your existing documentation
• Preparation of Device and Plant Master Files
• Application submission and follow-up on the CDSCO MD Online Portal
• Coordination with notified bodies and testing labs
• Training your team for audit readiness

Getting Started with Your CDSCO License Application for Bagolini Lens

1. Assess your manufacturing or import plans: Decide whether to manufacture locally or import.
2. Classify your device: Confirm Class A status and regulatory pathway.
3. Prepare required documents: Utilize our guides on DMF and PMF.
4. Apply for Test License (Form MD13): Submit via the CDSCO portal.
5. Schedule product testing: Contact government-approved labs early.
6. Engage a notified body: Select from the list of notified bodies for your audit.
7. Submit MD5 License application (Form MD3): Once testing and documentation are complete.
8. Respond promptly to queries: Maintain clear communication with CDSCO.

Embarking on your CDSCO license journey for the Bagolini lens with expert guidance ensures compliance, saves time, and accelerates market entry. Contact us today to leverage our proven expertise and streamline your regulatory approval process.