CDSCO License for Ophthalmic clip

Comprehensive Guide to CDSCO Licensing for Ophthalmic Clips (Class C Medical Device)

As a seasoned regulatory consultancy with over 25 years and more than 500 successful CDSCO license applications, we understand the nuances and complexities manufacturers and importers face. Ophthalmic clips, classified as Class C medical devices under the Indian regulatory framework, require meticulous preparation and compliance with CDSCO regulations to ensure timely market entry.

Understanding Ophthalmic Clips and Regulatory Importance

Ophthalmic clips are precision medical devices typically made from malleable metals like tantalum. They are designed for temporary or permanent implantation in the eye to hold wound edges together or prevent bleeding from small blood vessels. Given their critical role in ocular surgeries and the sensitive nature of ophthalmology, regulatory scrutiny is stringent to ensure safety and efficacy.

The Central Drugs Standard Control Organization (CDSCO) mandates rigorous licensing, testing, and auditing procedures for such Class C devices. Compliance not only ensures patient safety but also enables smooth commercialization across India.

CDSCO Regulatory Framework for Ophthalmic Clips

Ophthalmic clips fall under Class C as per the Medical Device Classification guidelines notified by CDSCO (Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021). For Class C devices, the manufacturing license is issued by the Central Licensing Authority and requires the MD9 license (Form MD7).

Risk Classification and License Requirements

• Device Name: Ophthalmic clip
• Risk Class: Class C
• License Type: MD9 Manufacturing License
• Regulatory Authority: CDSCO Central Licensing Authority

Class C devices like ophthalmic clips are considered moderate to high-risk and demand comprehensive documentation, testing, and regulatory audits before license issuance.

Manufacturing License Process (MD9 License)

Obtaining an MD9 license for ophthalmic clips involves multiple steps:

1. Test License (Form MD13): Initially, apply for a test license, which takes approximately 1.5 to 2 months. This allows product testing in government-approved laboratories.
2. Product Testing: Get the ophthalmic clip tested for compliance with applicable standards at CDSCO-recognized labs. Refer to the list of testing laboratories for approved facilities.
3. Document Preparation: Compile the required documentation, including Device Master File, Plant Master File, risk management files, and QMS documents.
4. Application Submission: Submit your manufacturing license application using Form MD7 via the CDSCO MD Online Portal.
5. Audit: CDSCO inspectors conduct an on-site audit to verify compliance with Good Manufacturing Practices (GMP) and QMS standards.
6. Query Resolution: Address any observations or queries raised during the audit or document review.
7. License Grant: Upon successful compliance, CDSCO grants the MD9 license.

This entire process typically takes 4 to 5 months.

Manufacturing License Documents Required for Ophthalmic Clips

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

• Company Constitution: Registration certificates, Memorandum & Articles of Association.
• Proof of Premises Ownership: Lease deed or ownership proof of the manufacturing site.
• Technical Staff Credentials: Qualifications and experience of key personnel.
• No Objection Certificates: Fire safety and pollution control clearances.
• Device Master File (DMF): Detailed design, materials used (e.g., tantalum), manufacturing process, and specifications. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF): Information about the manufacturing facility, equipment, and quality control processes. Refer to our Plant Master File guide for best practices.
• Essential Principles Checklist: Compliance with Indian Medical Device Rules (IMDR) essential principles.
• Risk Management File: Documented risk analysis and mitigation strategies addressing device-specific risks. See our risk management resource for implementation.
• Test Reports from Approved Labs: Validated safety and performance data.
• Labels and Instructions for Use (IFU): Compliant with regulatory standards.
• Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal SOPs.

Import License Process (MD15 License)

If you plan to import ophthalmic clips, the CDSCO requires an MD15 import license under the Central Licensing Authority. Unlike manufacturing, no test license is required.

Steps include:

1. Document Preparation: Compile manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, wholesale license, and company constitution.
2. Application Submission: Apply using Form MD14 on the CDSCO MD Online Portal.
3. Query Resolution: Address any clarifications requested by CDSCO.
4. License Grant: Typically takes 5 to 6 months.

Import License Documents Required

• Manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device Master File
• Plant Master File
• Wholesale license
• Company Constitution

Timeline and Processing Duration

Import licenses generally take 5 to 6 months.

Government Fees and Costs

• MD9 Manufacturing License:

  • Application Fee: ₹50,000
  • Per Product Fee: ₹1,000

• Test License (MD13): Included in the process, no separate fee beyond testing charges.

• Product Testing: Varies by lab and test complexity; expect ₹50,000 to ₹1,00,000 depending on parameters.

• Audit Fees: Conducted by CDSCO, no separate fee, but costs related to preparation and consultancy may apply.

Common Challenges and Practical Solutions

• Delayed Test Reports: Plan testing early by selecting reputed government-approved labs from the testing laboratories list. Maintain close follow-up.

• Incomplete Documentation: Use standardized templates for DMF and PMF and seek professional guidance to avoid rejections.

• Audit Non-Compliance: Conduct internal audits prior to CDSCO inspection. Ensure your QMS is robust and staff is trained.

• Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to avoid process stalls.

Expert Consultation and Support

With 25+ years of experience and over 500 companies assisted, our expert team offers end-to-end support:

• Gap analysis and regulatory strategy
• Documentation preparation (DMF, PMF, Risk Management)
• Liaison with CDSCO and notified bodies
• Internal audits and mock inspections
• Training for technical staff

Our insights reduce approval timelines and minimize costly compliance errors.

Getting Started with Your CDSCO License Application for Ophthalmic Clips

1. Assess Risk Classification: Confirm your device is Class C under CDSCO.
2. Initiate Test License Application: Submit Form MD13 on the CDSCO MD Online Portal.
3. Engage Approved Testing Labs: Select labs early using the official testing laboratories list.
4. Prepare Documentation: Develop your Device and Plant Master Files, risk management, and QMS documents.
5. Schedule Pre-Audit Checks: Conduct internal audits to identify gaps.
6. Submit Manufacturing License Application: Apply using Form MD7 for MD9 license.
7. Plan for Audit and Follow-ups: Prepare your team for inspection and timely query responses.

Starting early and adhering to timelines is critical for success. For detailed guidance tailored to your ophthalmic clip manufacturing or import business, reach out to our regulatory experts today.

Embark on your CDSCO licensing journey confidently with trusted expertise at your side.