CDSCO License for Ophthalmic Irrigation Solution (Balanced Salt Solution)

Comprehensive Guide to CDSCO Licensing for Ophthalmic Irrigation Solution (Balanced Salt Solution)

Ophthalmic Irrigation Solution, specifically the Balanced Salt Solution (BSS), plays a critical role in ophthalmic surgeries such as cataract procedures and other intraocular or extraocular interventions. Its intended use includes irrigation of the anterior chamber during surgeries, moistening corneal surfaces during laser treatments, and conjunctival irrigation following fluorescein application. Given its direct contact with sensitive eye tissues, regulatory compliance is paramount to ensure safety and efficacy.

With over 25 years of experience assisting more than 500 companies navigate the Indian regulatory landscape, we provide clear, actionable guidance for manufacturers and importers seeking CDSCO licensing for Ophthalmic Irrigation Solution, classified as a Class B medical device under the CDSCO Medical Device Classification.

CDSCO Regulatory Framework for Ophthalmic Irrigation Solutions

In India, ophthalmic irrigation solutions fall under the category of medical devices regulated by the Central Drugs Standard Control Organization (CDSCO). This device is notified under File Number 29/MiscJO3/2020-DC (187), effective from 9th August 2021, and is classified as a Class B device due to its moderate risk profile.

Class B devices require adherence to specific manufacturing and import licensing procedures, including quality management system compliance, device testing, and audits by notified bodies. The regulatory pathway ensures that products like Balanced Salt Solution meet essential principles of safety, performance, and quality.

Risk Classification and License Requirements

Balanced Salt Solution for ophthalmic irrigation is classified as a Class B medical device. This classification triggers the requirement for an MD5 Manufacturing License for domestic manufacturers or an MD15 Import License for importers.

• Class B devices: Moderate risk, requiring State Licensing Authority approval for manufacturing (MD5 License) and Central Licensing Authority approval for import (MD15 License).
• License Forms:
  • MD5 License uses Form MD3 for application and is issued by the State Authority.
  • MD15 License uses Form MD14 for application and is issued by the Central Authority.

Manufacturing License Process for Ophthalmic Irrigation Solution (MD5 License)

If you are a manufacturer of Balanced Salt Solution in India, you must obtain an MD5 Manufacturing License. The process involves several sequential steps:

1. Test License Application (Form MD13): Before the full license, apply for a test license, which is mandatory for the product testing phase. This takes approximately 1.5 to 2 months.
2. Product Testing: Conduct product testing at CDSCO-approved laboratories. Testing covers sterility, pH, osmolarity, and other quality parameters relevant to ophthalmic irrigation solutions. Refer to the list of CDSCO-approved testing laboratories for accredited facilities.
3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
4. Application for MD5 License (Form MD3): Submit the complete application via the CDSCO MD Online Portal to the State Licensing Authority.
5. Audit by Notified Body: A notified body conducts a manufacturing site audit. You can verify the authorized bodies on the Notified Bodies List.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon successful audit and document review, the MD5 license is granted.

For detailed insights, our MD5 License Guide provides step-by-step instructions tailored to Class B devices.

Manufacturing License Documents Required for Balanced Salt Solution

The document package is extensive to ensure full regulatory compliance:

• Company Constitution and Incorporation Certificate
• Proof of ownership or lease of manufacturing premises
• Qualification and experience documents for technical and managerial staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) detailing design, formulation, and manufacturing process (our DMF guide can assist)
• Plant Master File (PMF) outlining facility infrastructure and equipment (PMF guide available here)
• Essential Principles Compliance Checklist
• Risk Management File aligned with ISO 14971 principles (risk management insights)
• Product Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU) in compliance with CDSCO guidelines
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process for Ophthalmic Irrigation Solution (MD15 License)

For importers, the MD15 Import License is mandatory before marketing Balanced Salt Solution in India. The process is governed by the Central Licensing Authority and involves:

1. Document Preparation: Compile all required documents, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: Submit Form MD14 via the CDSCO MD Online Portal.
3. Review and Query Resolution: CDSCO reviews the application and may raise clarifications.
4. License Grant: Upon satisfactory review, the MD15 license is issued.

Our Import License Guide offers detailed procedural assistance.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or Certificate of Marketing Authorization
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale Drug License
• Company Constitution and Incorporation Certificate
• Labeling and IFU

Timeline and Processing Duration

For import licenses (MD15), the timeline is generally 5-6 months due to central authority review and documentation complexity.

Government Fees and Costs

• MD5 License (Class B) Fees:
  • Application Fee: INR 5,000
  • Per Product Fee: INR 500
• MD15 Import License Fees:
  • For Class B devices: INR 200,000 (approximately $2,000) per site
  • INR 100,000 (approximately $1,000) per product

Additional costs include testing fees at approved laboratories and audit fees payable to notified bodies.

Common Challenges and Solutions

• Delayed Test Reports: Testing at approved labs can be a bottleneck; pre-book lab slots and ensure sample compliance to avoid retesting.
• Incomplete Documentation: Comprehensive preparation of DMF and PMF reduces audit queries. Utilize specialized templates and experienced consultants.
• Audit Non-Compliance: Familiarize with notified body requirements and conduct internal mock audits beforehand.
• Query Delays: Respond promptly and thoroughly to CDSCO queries to avoid unnecessary delays.

Expert Consultation and Support

Navigating CDSCO licensing for ophthalmic irrigation solutions demands expertise in both documentation and regulatory nuances. Our seasoned consultants provide:

• Customized gap analysis of your current compliance status
• End-to-end assistance in preparing DMF, PMF, and QMS
• Coordination with notified bodies for audits
• Liaison with CDSCO officials to expedite processing

We have successfully facilitated over 500 CDSCO license acquisitions, ensuring timely market entry and regulatory compliance.

Getting Started with Your CDSCO License Application for Balanced Salt Solution

1. Evaluate Your Product Classification: Confirm Class B status and applicable regulatory requirements.
2. Gather Preliminary Documents: Company incorporation, facility ownership, technical staff credentials.
3. Engage a CDSCO-Approved Testing Laboratory: Schedule testing to align with your timeline.
4. Prepare Device and Plant Master Files: Use our comprehensive guides to streamline this process.
5. Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
6. Plan for Audit: Select a notified body and prepare your site accordingly.
7. Submit MD5 Application: Once testing and documents are ready, file Form MD3 for manufacturing license.

Starting early and meticulously preparing your dossier significantly reduces processing timelines and enhances your chances of approval.

For tailored support and to accelerate your CDSCO license application for Ophthalmic Irrigation Solution, connect with our expert regulatory team today.