CDSCO License for Capsular bag anchor

Comprehensive Guide to CDSCO License for Capsular Bag Anchor (Class C Medical Device)

Navigating the regulatory landscape for innovative ophthalmic devices like the Capsular Bag Anchor demands precision, compliance, and strategic planning. As a Class C medical device intended for permanent implantation in the eye's posterior chamber, this device plays a critical role in correcting and fixing subluxated capsular bags alongside intraocular lens (IOL) implantation. Understanding the Central Drugs Standard Control Organization (CDSCO) framework is essential for manufacturers and importers who aim to launch this device in the Indian market.

With over 25 years of experience and having assisted more than 500 companies in obtaining CDSCO licenses, we provide you with a detailed, actionable roadmap tailored for your Capsular Bag Anchor.

CDSCO Regulatory Framework for Ophthalmic Implant Devices

The CDSCO regulates medical devices under the Medical Device Rules, 2017, classifying devices based on risk and intended use. Ophthalmic implantables such as the Capsular Bag Anchor fall under Class C owing to their invasive and high-risk nature. This classification mandates stringent licensing and quality assurance processes, including audits and testing.

The official notification governing this device is Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. Compliance with these specific regulatory requirements is non-negotiable for market entry.

Risk Classification and License Requirements for Capsular Bag Anchor

Being a Class C device, the Capsular Bag Anchor requires a CDSCO MD9 Manufacturing License (Form MD7) if manufactured in India. For importers, an MD15 Import License (Form MD14) issued by the Central Licensing Authority is mandatory.

Key Points:

• Class: C (High risk, invasive implant)
• Regulatory Authority: Central Licensing Authority (CDSCO HQ)
• License Type: MD9 for manufacturing; MD15 for import

You can verify device classification and related compliance details at our Medical Device Classification guide.

Manufacturing License Process (MD9) for Capsular Bag Anchor

Step 1: Obtain Test License (Form MD13)

Before applying for the MD9 license, manufacturers must secure a test license on Form MD13. This allows legal sample production for testing.

• Timeline: Approximately 1.5 to 2 months
• Testing: Conducted at CDSCO-approved laboratories such as those listed on the CDSCO Testing Laboratories portal

Step 2: Product Testing

The Capsular Bag Anchor must undergo rigorous testing for biocompatibility, sterility, mechanical integrity, and performance. Testing is crucial for compliance with the Essential Principles of Safety and Performance.

Step 3: Document Preparation

Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Quality Management System (QMS) documents, and product-specific files.

Step 4: Application Submission

Submit the MD9 license application on Form MD7 through the CDSCO MD Online Portal, attaching all required documents.

Step 5: CDSCO Audit

CDSCO inspectors will audit your manufacturing facility and documentation. The audit assesses compliance with GMP and QMS standards.

Step 6: Query Resolution

Respond promptly to any queries raised by CDSCO or notified bodies to avoid delays.

Step 7: License Grant

Upon successful review and audit, the MD9 license will be granted on Form MD9.

For an in-depth walkthrough, visit our MD9 License Guide.

Manufacturing License Documents Required for Class C Devices

• Company Constitution and Incorporation Certificates
• Proof of Ownership or Lease of Manufacturing Premises
• Credentials of Technical and Quality Personnel
• Fire and Pollution NOCs
• Device Master File (DMF) detailing design, manufacturing processes, and control
• Plant Master File (PMF) outlining facility details and equipment
• Essential Principles Checklist demonstrating compliance
• Risk Management File per ISO 14971 standards
• Test Reports from CDSCO-approved labs
• Labels, Instructions for Use (IFU), and packaging details
• Quality Management System documentation (ISO 13485:2016 preferred)

Our Device Master File guide and Plant Master File guide provide templates and best practices.

Import License Process (MD15) for Capsular Bag Anchor

Step 1: Document Preparation

Gather all technical and quality documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE mark if applicable, and other regulatory approvals.

Step 2: Application Submission

Submit Form MD14 for the MD15 import license on the CDSCO MD Online Portal.

Step 3: Queries and Review

Address any clarifications requested by CDSCO promptly.

Step 4: License Issuance

Upon satisfactory review, the import license is granted on Form MD15.

Full guidance is available in our Import License Guide.

Timeline and Processing Duration

Import license processing typically takes 5 - 6 months.

Government Fees and Costs

For MD15 Import License fees (approximate):

• Class C Devices: $3,000 per site,$1,500 per product

Note: Fees are subject to change; always verify on the CDSCO MD Online Portal.

Common Challenges and Practical Solutions

Challenge 1: Delays in Product Testing

Solution: Engage with CDSCO-approved laboratories early. Schedule testing slots in advance and ensure samples meet test protocol requirements.

Challenge 2: Incomplete Documentation

Solution: Use comprehensive checklists and consult experts to prepare DMF, PMF, and Risk Management files. Our detailed guides help avoid common pitfalls.

Challenge 3: Audit Non-compliance

Solution: Conduct internal pre-audit assessments and train your staff thoroughly on GMP and documentation.

Challenge 4: Query Resolution Delays

Solution: Assign a dedicated regulatory liaison to monitor and respond to CDSCO queries swiftly, minimizing back-and-forth.

For in-depth risk mitigation strategies, explore our Risk Management resource.

Expert Consultation and Support

Our extensive experience in ophthalmic device regulation ensures you receive tailored support throughout your CDSCO licensing journey. From preparing your Device Master File to facilitating audits and addressing CDSCO queries, our proven methodology accelerates approval timelines and minimizes risks.

We also assist in leveraging notified bodies for audits; review the list of notified bodies recognized by CDSCO.

Getting Started with Your CDSCO License Application for Capsular Bag Anchor

1. Confirm Device Classification: Verify your device’s Class C status and regulatory pathway.
2. Prepare Technical Documentation: Utilize our guides to compile your DMF, PMF, risk management, and QMS documents.
3. Apply for Test License (Form MD13): Submit via the CDSCO MD Online Portal to initiate product testing.
4. Plan Testing and Audit: Schedule testing at CDSCO-approved labs and prepare for the manufacturing site audit.
5. Submit MD9 Application: After successful testing, apply for the MD9 license, ensuring all documentation is complete.
6. Engage Expert Support: Consider partnering with regulatory consultants to streamline processes and handle complex queries.

Embarking on this process early and methodically will position your Capsular Bag Anchor for successful regulatory approval and timely market entry in India. Contact us today to leverage our 25+ years of regulatory expertise and ensure a seamless CDSCO licensing experience.