CDSCO License for Binocular vision test unit

Comprehensive Guide to CDSCO Licensing for Binocular Vision Test Units (Class A Ophthalmic Device)

As a trusted regulatory consultant with over 25 years of experience and having successfully supported 500+ companies in securing CDSCO licenses, we understand the nuances and critical requirements for bringing ophthalmic devices like Binocular Vision Test Units to the Indian market. This device, classified under Class A (low risk) as per the CDSCO notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, requires compliance with specific regulatory mandates that ensure safety, efficacy, and quality.

CDSCO Regulatory Framework for Binocular Vision Test Units

The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules, 2017. Binocular vision test units, being ophthalmic devices, fall under the purview of CDSCO and are notified as Class A devices. This classification mandates obtaining a manufacturing license (MD5 license) from the State Licensing Authority before manufacturing or marketing.

Risk Classification and License Requirements

Binocular Vision Test Units are categorized as Class A medical devices due to their low risk profile. According to the classification:

• Class A devices require an MD5 manufacturing license (application form MD3) granted by the State Licensing Authority.
• The entire licensing process typically takes 3 to 4 months, including testing, audits, and documentation.

For detailed understanding of device classifications, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5 License)

The MD5 license process is methodical and involves multiple stages:

1. Test License (Form MD13): Obtaining a test license is the first step, allowing initial testing of the device. This takes approximately 1.5 to 2 months.
2. Product Testing: Samples of the Binocular Vision Test Unit must be tested at CDSCO-approved laboratories. Refer to the list of testing laboratories for authorized labs.
3. Document Preparation: Compilation of comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.
4. Application Submission: Submit the application for the MD5 license using Form MD3 through the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit is conducted by a notified body from the approved Notified Bodies list.
6. Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
7. License Grant: Upon successful audit and review, the MD5 license (Form MD5) is granted.

Manufacturing License Documents Required

Manufacturers must provide comprehensive documentation to support their application, including:

• Company Constitution Documents: Incorporation certificate, memorandum, articles of association.
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications and Experience
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed design, manufacturing, and packaging information. Our Device Master File guide offers practical insights.
• Plant Master File (PMF): Manufacturing site details as per the Plant Master File guide.
• Essential Principles Checklist: Compliance with Indian Medical Device Rules’ essential principles.
• Risk Management File: Evidence of risk assessment and mitigation strategies. Explore best practices in our Risk Management guide.
• Test Reports: From CDSCO-approved labs validating device safety and performance.
• Labels and Instructions for Use (IFU): As per Indian regulatory standards.
• Quality Management System Documentation: Typically ISO 13485:2016 certification.

Import License Process (MD15 License)

For importers of Binocular Vision Test Units, the MD15 license is mandatory, issued by the Central Licensing Authority. The process includes:

• Preparation of all necessary documents including manufacturing license, free sale certificate, ISO certification, CE certificate, device and plant master files.
• Submission of application on Form MD14 through the CDSCO MD Online Portal.
• Resolution of queries raised by the CDSCO.
• License grant within approximately 5 to 6 months.

Refer to our detailed Import License Guide for a stepwise approach.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and ownership proofs

Timeline and Processing Duration

Planning for a total lead time of approximately 3 to 4 months is essential to avoid costly delays.

Government Fees and Costs

• Application Fee: Rs. 5000 per application
• Per Product Fee: Rs. 500 per product

These fees are payable online via the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays in obtaining test reports from approved laboratories.

Solution: Engage early with accredited labs and schedule sample testing in advance.

Challenge: Incomplete or inconsistent documentation leading to audit queries.

Solution: Employ a checklist-based approach for document preparation and leverage expert consultation.

Challenge: Audit non-compliance due to gaps in QMS or facility standards.

Solution: Conduct internal pre-audits and staff training to ensure readiness.

Expert Consultation and Support

Navigating the CDSCO licensing landscape for Class A ophthalmic devices like Binocular Vision Test Units can be complex. Our seasoned team offers:

• Tailored regulatory strategy
• Document preparation and review
• Pre-audit assessments
• Liaison with CDSCO and notified bodies

Partnering with experts significantly enhances the likelihood of timely license grant and market entry.

Getting Started with Your CDSCO License Application

1. Determine Device Classification: Confirm Binocular Vision Test Unit as Class A via CDSCO guidelines.
2. Initiate Test License Application (Form MD13): Submit through the CDSCO MD Online Portal.
3. Engage CDSCO-Approved Testing Lab: Arrange for product testing as early as possible.
4. Prepare Comprehensive Documentation: Use our Device Master File and Plant Master File guides.
5. Schedule Audit with Notified Body: Select from the official Notified Bodies list.
6. Submit MD5 License Application (Form MD3): Upload all documents via the online portal.
7. Respond Promptly to Queries: Maintain open communication with CDSCO and auditors.

By following these actionable steps and leveraging decades of regulatory expertise, manufacturers and importers can confidently navigate the CDSCO licensing process for Binocular Vision Test Units and successfully enter the Indian ophthalmology market.

For personalized support or detailed consultation, contact our regulatory experts who specialize in medical device compliance and CDSCO licensing.