CDSCO License for Sclerotome

CDSCO License for Sclerotome: Expert Guide for Class A Ophthalmic Devices

As a hand-held manual ophthalmic surgical instrument, the Sclerotome plays a precise role in incising the sclera during sclerotomy. Classified as a Class A medical device under the CDSCO regulatory framework, it represents the lowest risk category. However, the regulatory pathway to market entry in India involves a detailed process to ensure patient safety and product efficacy. With over 25 years of experience and having guided 500+ companies through CDSCO licensing, we provide you with an actionable, step-by-step guide tailored specifically for the Sclerotome.

Understanding CDSCO Regulatory Framework for Sclerotome

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. The notification Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021, officially classifies the Sclerotome as a Class A device under the ophthalmology category. This classification means it is considered low risk, but it still requires full compliance with CDSCO’s licensing and quality management protocols.

Manufacturers or importers must secure the appropriate license before marketing or distributing the device in India. For Class A devices like the Sclerotome, the State Licensing Authority issues the manufacturing license known as the MD5 license.

Risk Classification and License Requirements for Sclerotome

Given the Sclerotome’s classification as Class A, the following regulatory requirements apply:

• License Type: MD5 (Manufacturing License for Class A devices)
• Regulatory Authority: State Licensing Authority
• Application Form: MD3 for license application, MD13 for test license
• Process Duration: Approximately 3 to 4 months end-to-end
• Fees: Rs. 5,000 per application + Rs. 500 per product

You can refer to the Medical Device Classification guide to understand the rationale behind this classification.

Manufacturing License Process for Sclerotome (MD5 License)

The manufacturing license process for Class A devices like the Sclerotome follows a multi-step approach:

1. Obtain Test License (Form MD13): Before manufacturing, apply for a test license, which typically takes 1.5 to 2 months. This license allows you to produce samples for testing.

2. Product Testing: Get the Sclerotome tested at CDSCO-approved government labs. You can find the list of testing laboratories here.

3. Document Preparation: Compile all necessary documents, including technical files and quality management system (QMS) records.

4. Submit Manufacturing License Application (Form MD3): Apply for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: The State Licensing Authority will assign a notified body to audit your manufacturing site. Check the list of notified bodies for audit arrangements.

6. Respond to Queries: Address any observations or queries raised by the department or notified body promptly.

7. License Grant: Following successful audit and query resolution, the MD5 license is granted on Form MD5.

We recommend reviewing our MD5 license guide for detailed insights.

Manufacturing License Documents Required for Sclerotome

Preparing a thorough and compliant dossier is critical. For the Sclerotome, you’ll need:

• Company constitution documents (e.g., incorporation certificate)
• Proof of ownership or lease of manufacturing premises
• Details and qualifications of technical staff
• Fire safety and pollution control clearances (NOCs)
• Device Master File describing the design, materials, and specifications (Device Master File guide)
• Plant Master File detailing manufacturing processes and quality controls (Plant Master File guide)
• Essential Principles Checklist demonstrating compliance with CDSCO guidelines
• Risk Management File outlining hazard analysis and mitigation strategies (Risk Management guide)
• Test reports from approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, ideally ISO 13485:2016 compliant

Attention to detail here can prevent delays during the audit and licensing process.

Import License Process for Sclerotome (MD15 License)

If you intend to import the Sclerotome into India rather than manufacture locally, you must apply for the MD15 import license from the Central Licensing Authority. The import license process includes:

• Detailed document preparation, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device and Plant Master Files, and wholesale license.

• Submit the application using Form MD14 via the CDSCO MD Online Portal.

• The process takes approximately 5 to 6 months due to thorough scrutiny.

• Applicable fees depend on the risk class; for Class A devices, approximately $1000 per site and$50 per product.

For more information, consult our Import License guide.

Timeline and Processing Duration for Sclerotome Licensing

Total estimated timeframe: 3 to 4 months for manufacturing license (MD5).

Government Fees and Costs Breakdown

• Test License (MD13): Approximately Rs. 5,000 (varies by state)
• MD5 License Application: Rs. 5,000 per application
• Per Product Fee: Rs. 500 for the Sclerotome
• Testing Charges: Dependent on lab rates (typically Rs. 20,000 to Rs. 40,000 per product)
• Audit Fees: Charged by the notified body, varies by scope

Budgeting accurately upfront helps avoid financial surprises.

Common Challenges and Practical Solutions

• Delays in Test Reports: Testing labs can be overwhelmed; plan submissions early and consider multiple labs.
• Incomplete Documentation: Missing or inconsistent documents cause query back-and-forth; use detailed checklists.
• Audit Non-Compliance: Ensure your manufacturing site strictly follows QMS and safety norms before audit.
• Staff Qualification Gaps: Recruit or train technical staff with relevant medical device manufacturing expertise.

Our hands-on experience with over 500 companies ensures we anticipate these hurdles and help you navigate them smoothly.

Expert Consultation and Support

Navigating CDSCO’s regulatory landscape can be complex. Leveraging expert consultants with a proven track record can accelerate approvals and mitigate risks. Our team provides:

• Tailored document preparation and review
• Strategic planning of test and audit schedules
• Liaison with CDSCO officials and notified bodies
• Training for your technical and quality teams

Engaging expert support transforms compliance from a challenge into a competitive advantage.

Getting Started with Your CDSCO License Application for Sclerotome

1. Assess Your Manufacturing or Import Strategy: Decide if you will manufacture locally or import.
2. Classify Your Device: Confirm Class A status as per CDSCO notification.
3. Prepare Documentation: Gather all required files, including Device and Plant Master Files.
4. Apply for Test License: Initiate the process via the CDSCO MD Online Portal.
5. Plan Product Testing: Schedule testing at approved labs promptly.
6. Schedule Audit Preparation: Align your facility and QMS for the notified body audit.
7. Submit Manufacturing License Application: Complete Form MD3 application for MD5 license.
8. Engage with Authorities: Respond promptly to any queries or observations.

Starting early and following a structured approach is key to success. Feel free to reach out to our expert team to discuss your Sclerotome licensing project and get personalized guidance.

By following these expert steps, manufacturers and importers can confidently navigate the CDSCO regulatory process and bring the Sclerotome safely and compliantly to the Indian ophthalmology market.