CDSCO License for Mirror-prism spectacles

Introduction to Mirror-Prism Spectacles and Regulatory Importance

Mirror-prism spectacles are specialized ophthalmic devices designed to assist patients by enabling them to see over the top of their heads, allowing forward vision aligned with head orientation. This innovative optical device falls under Class A, the lowest risk category as per CDSCO regulations, reflecting its non-invasive nature and limited risk profile. Despite being low risk, obtaining the correct CDSCO license is critical for legal manufacturing and marketing in India. Compliance ensures patient safety, market access, and business credibility.

With over 25 years of experience guiding 500+ manufacturers through CDSCO licensing, we understand the nuances involved in successfully securing manufacturing and import licenses for Class A devices like mirror-prism spectacles. This comprehensive guide will walk you through the entire regulatory journey with actionable insights tailored specifically for this device category.

CDSCO Regulatory Framework for Mirror-Prism Spectacles

The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Mirror-prism spectacles are regulated under the ophthalmology category and classified as Class A medical devices according to the Medical Device Rules, 2017 and subsequent notifications, including Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

Since Class A devices are considered low risk, the MD5 license issued by the State Licensing Authority is required for manufacturing within India. For imports, an MD15 license from the Central Licensing Authority is mandatory.

Risk Classification and License Requirements for Mirror-Prism Spectacles

• Risk Class: A (Low risk)
• License Type: MD5 Manufacturing License (Form MD3) for domestic manufacturers
• Test License: MD13 Test License is mandatory before full license application
• Regulatory Authority: State Licensing Authority for manufacturing
• Typical Timeline: 3 to 4 months total process

The classification as Class A means the licensing procedure is streamlined but still requires rigorous documentation, product testing, and facility audits.

Manufacturing License Process (MD5) for Mirror-Prism Spectacles

1. Obtain MD13 Test License: Apply for a test license using Form MD13 via the CDSCO MD Online Portal. This allows limited manufacturing for testing purposes. Processing time is approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-approved laboratories to verify compliance with essential principles. Consult the Testing Laboratories list for authorized labs.

3. Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, test reports, labels, and Instructions for Use (IFU).

4. Submit MD5 Application: File the manufacturing license application using Form MD3 through the online portal.

5. Facility Audit: A notified body conducts an on-site audit. Check the list of notified bodies for authorized auditors.

6. Query Resolution: Address any queries or deficiencies raised by CDSCO or the notified body promptly.

7. License Grant: Upon satisfactory review and audit, the MD5 license is issued in Form MD5, authorizing commercial manufacturing.

Manufacturing License Documents Required for Mirror-Prism Spectacles

• Company constitution and incorporation certificates
• Proof of ownership or lease of manufacturing premises
• Details of technical staff qualifications and experience
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design and manufacturing process (Device Master File Guide)
• Plant Master File documenting manufacturing facility (Plant Master File Guide)
• Essential Principles Checklist confirming device compliance
• Risk Management File demonstrating risk assessment and mitigation (Risk Management)
• Test license (MD13) and product test reports from approved labs
• Sample labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485:2016 certification recommended)

Import License Process (MD15) for Mirror-Prism Spectacles

For importers, the process involves applying for an MD15 license from the Central Licensing Authority:

1. Documentation Preparation: Compile manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, Device Master File, Plant Master File, wholesale license, and company constitution.

2. Application Submission: Apply online with Form MD14 through the CDSCO MD Online Portal.

3. Evaluation: CDSCO reviews documents and may raise queries.

4. License Grant: After satisfactory evaluation, license is issued on Form MD15.

Typical timeline is 5 to 6 months.

Import License Documents Required

• Valid manufacturing license from origin country
• Free Sale Certificate
• ISO 13485:2016 certificate
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale license for distribution
• Company constitution and incorporation documents

Timeline and Processing Duration

From our experience, proactive preparation of documents and early engagement with notified bodies can reduce delays significantly.

Government Fees and Costs

• MD5 License: Application fee Rs. 5,000 + Rs. 500 per product
• MD13 Test License: Included in MD5 process fees
• MD15 Import License: For Class A devices, approximately $1000 per site +$50 per product

Additional costs to consider:

• Testing laboratory fees (depend on number and complexity of tests)
• Notified body audit fees (varies by auditor)
• Consulting and documentation preparation fees if outsourced

Common Challenges and Solutions

Challenge 1: Delays in test license approvals and testing

Solution: Initiate test license application early. Select CDSCO-approved labs with shorter turnaround times and confirm testing scope upfront.

Challenge 2: Incomplete or inconsistent documentation

Solution: Use standardized templates for Device Master File and Plant Master File as per CDSCO guidelines. Our Plant Master File guide and Device Master File guide help streamline documentation.

Challenge 3: Audit non-compliance findings

Solution: Conduct internal mock audits before notified body visits to ensure QMS and documentation meet requirements.

Challenge 4: Query response delays

Solution: Assign a dedicated regulatory person/team to respond quickly and comprehensively to CDSCO queries.

Expert Consultation and Support

Navigating CDSCO licensing for mirror-prism spectacles can be complex despite the Class A classification. Our 25+ years of expertise have empowered over 500 companies to successfully obtain licenses efficiently. We provide:

• End-to-end application preparation and submission
• Customized DMF and PMF documentation
• Support for product testing coordination
• Pre-audit readiness and gap analysis
• Query response and liaison with CDSCO officials

Partnering with seasoned consultants reduces risk of rejections and accelerates market entry.

Getting Started with Your CDSCO License Application

1. Assess your product classification carefully to confirm Class A status using the Medical Device Classification tool.

2. Register on the CDSCO MD Online Portal to access application forms and track submissions.

3. Prepare your facility and quality systems in line with ISO 13485:2016 standards.

4. Compile key documents: start with Device Master File, Plant Master File, Essential Principles Checklist, and Risk Management File.

5. Apply for the MD13 Test License to begin limited manufacturing and product testing.

6. Select a notified body and approved testing laboratory early to schedule audits and tests.

7. Submit your MD5 application after successful test license approval and product testing.

8. Engage with regulatory experts for a smooth audit and query resolution process.

By following these steps and leveraging expert guidance, manufacturers and importers of mirror-prism spectacles can confidently navigate the CDSCO licensing landscape and bring this valuable optical device to the Indian market.

For detailed assistance, visit the official CDSCO MD Online Portal and access comprehensive resources tailored to your licensing needs.