CDSCO License for Flieringa ophthalmic ring

Comprehensive Guide to CDSCO Licensing for Flieringa Ophthalmic Ring – Class A Medical Device in Ophthalmology

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized ophthalmic devices like the Flieringa ophthalmic ring. This device, classified as Class A under CDSCO regulations and notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, plays a critical role during intraocular surgeries by preventing the collapse of the globe. Given its vital function and low-risk classification, obtaining the correct CDSCO license is essential for manufacturers and importers aiming to enter the Indian market.

With over 25 years of regulatory consulting experience and having assisted more than 500 companies in securing CDSCO licenses, we provide you with an insider’s roadmap to efficiently acquire your manufacturing or import license for this device.

Understanding the CDSCO Regulatory Framework for the Flieringa Ophthalmic Ring

The Central Drugs Standard Control Organization (CDSCO) regulates all medical devices under the Medical Device Rules, 2017, enforced since January 1, 2018. The Flieringa ophthalmic ring, being a Class A device—a low-risk category—falls under the purview of state licensing authorities for manufacturing licenses.

Because this device is specifically notified (Fts No. 29/MiscJO3/2020-DC (187)), it must comply with all relevant essential principles and quality management norms set forth by CDSCO. Compliance ensures patient safety and market authorization.

Risk Classification and License Requirements for the Flieringa Ophthalmic Ring

As a Class A device, the Flieringa ophthalmic ring is considered low risk. The manufacturing license required is the MD5 license, issued by the State Licensing Authority. If you intend to import this device, the import license type is MD15, issued by the Central Licensing Authority.

Key Points:

• Risk Class: A (Low Risk)
• Relevant License for Manufacturing: MD5 (Form MD3)
• Relevant License for Import: MD15 (Form MD14)

For detailed risk classifications, manufacturers can refer to our Medical Device Classification guide.

Manufacturing License Process for Flieringa Ophthalmic Ring (MD5 License)

The MD5 manufacturing license process involves several critical steps:

1. Obtain a Test License (MD13): Before applying for the manufacturing license, you must secure a test license to conduct product testing, which typically takes 1.5 to 2 months.
2. Product Testing: Testing must be conducted at government-approved laboratories. Refer to the CDSCO Testing Laboratories list to select an appropriate facility.
3. Document Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and QMS documentation.
4. Application Submission: Apply online via the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: An audit is conducted by a notified body (find the list of notified bodies here). This ensures compliance with GMP and quality standards.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. Grant of License: Upon satisfactory fulfillment of all requirements, the MD5 license is granted.

The entire process typically takes 3 to 4 months.

Manufacturing License Documents Required for the Flieringa Ophthalmic Ring

Gathering and organizing the following documents is crucial for a smooth licensing process:

• Company Constitution/Registration Certificate
• Proof of Ownership or Tenancy of Manufacturing Premises
• Technical Staff Qualifications and Experience Documents
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed description of device design, specifications, and manufacturing process. See our Device Master File guide for best practices.
• Plant Master File (PMF): Details on manufacturing facility, equipment, and processes. Learn how to prepare this with our Plant Master File guide.
• Essential Principles Checklist: Compliance with Indian medical device regulations.
• Risk Management File: Identification and mitigation strategies for device risks. For implementation tips, visit our Risk Management page.
• Test Reports from Approved Laboratories
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents, e.g., ISO 13485 certification or equivalent

Import License Process for the Flieringa Ophthalmic Ring (MD15 License)

Importers of the Flieringa ophthalmic ring require the MD15 license, granted by the Central Licensing Authority. The process entails:

1. Document Compilation: Assemble all required documents including manufacturing license of the product’s origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, Device and Plant Master Files, and wholesale license.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Review and Query Resolution: CDSCO reviews the application and raises queries if applicable.
4. License Grant: On satisfactory review, the MD15 import license is issued.

The timeline generally spans 5 to 6 months.

Import License Documents Required

• Manufacturing License of the Manufacturer (Country of Origin)
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or Equivalent International Approval
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution and Registration Documents

Timeline and Processing Duration

Government Fees and Costs

For the Flieringa ophthalmic ring (Class A device), the fee structure is as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
• MD15 Import License: $1,000 per site +$50 per product

These fees are payable online during application submission on the CDSCO portal.

Common Challenges and Solutions

Challenge: Delays in test license approval or product testing.

• Solution: Engage early with notified testing labs and submit complete, accurate test license applications to avoid back-and-forth.

Challenge: Gaps in documentation, especially Device and Plant Master Files.

• Solution: Utilize professional templates and ensure documents reflect actual manufacturing processes. Our guides on Device Master File and Plant Master File can expedite this.

Challenge: Audit non-compliance.

• Solution: Pre-audit your facility using checklists and standards provided by notified bodies.

Challenge: Delayed query responses prolonging license grant.

• Solution: Assign a dedicated regulatory expert to handle queries promptly and comprehensively.

Expert Consultation and Support

With our extensive experience in assisting over 500 companies, we offer tailored consultancy services that cover:

• End-to-end license application preparation
• Technical document development and review
• Coordination with notified bodies and testing laboratories
• Audit readiness and compliance training
• Query management and liaison with CDSCO officers

Our proactive approach ensures your Flieringa ophthalmic ring reaches the Indian market with minimal regulatory hurdles.

Getting Started with Your CDSCO License Application for the Flieringa Ophthalmic Ring

1. Review Your Device Classification and Confirm License Type: For the Flieringa ophthalmic ring, this is an MD5 manufacturing license.
2. Gather Required Documents: Begin assembling your Device Master File, Plant Master File, risk management documents, and technical staff credentials.
3. Initiate Test License Application: Submit Form MD13 via the CDSCO MD Online Portal and prepare for product testing.
4. Engage with Approved Testing Laboratories: Coordinate testing promptly to avoid bottlenecks.
5. Plan for Notified Body Audit: Schedule your audit early and conduct internal pre-audits.
6. Submit MD5 Application (Form MD3): Upload all documentation and pay applicable fees online.
7. Respond Promptly to Queries: Maintain clear communication with CDSCO and your notified body.

By following these actionable steps and leveraging expert support, your Flieringa ophthalmic ring can successfully obtain the required CDSCO license and enter the Indian healthcare market with confidence.