CDSCO License for Hand-held campimeter

Comprehensive CDSCO Licensing Guide for Hand-held Campimeter (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience facilitating CDSCO licensing for more than 500 medical device companies, we understand the intricacies of bringing a Class A ophthalmology device like the Hand-held Campimeter into the Indian market. This portable, hand-held visual field assessment device falls under Class A – the lowest risk category – but still requires strict compliance with India's medical device regulations to ensure safety and efficacy.

CDSCO Regulatory Framework for Hand-held Campimeter

The Central Drugs Standard Control Organization (CDSCO) governs all medical device approvals in India. Since the Hand-held Campimeter is classified as a Class A medical device under ophthalmology (Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021), it mandates obtaining a manufacturing license (MD5) from the State Licensing Authority before commercialization.

This regulatory framework ensures that even low-risk devices meet quality standards, including product testing, quality management systems (QMS), and adherence to essential principles.

Risk Classification and License Requirements

The Hand-held Campimeter is classified as Class A, indicating low risk. For Class A devices, the CDSCO requires:

• Manufacturing License (MD5 License) issued by the State Licensing Authority
• Application via Form MD3 on the CDSCO MD Online Portal
• Prior acquisition of a Test License (Form MD13) for product testing
• Compliance with QMS and documentation requirements

Manufacturing License Process (MD5 for Class A Devices)

The MD5 license process involves multiple key steps:

1. Apply for Test License (Form MD13): Mandatory for initial product testing at CDSCO-approved labs. This step typically takes 1.5 to 2 months.
2. Product Testing: Submit samples to government-approved testing laboratories listed on the CDSCO testing laboratories page. Testing duration varies based on device complexity but usually completes within 30-45 days.
3. Document Preparation: Compile all required documents, including Device Master File and Plant Master File.
4. Apply for Manufacturing License (Form MD3): Submit application with all supporting documents.
5. Audit by Notified Body: State authorities assign a notified body for an audit. Refer to the Notified Bodies List to identify your auditor.
6. Respond to Queries: Address any observations or deficiencies raised during audit or by CDSCO.
7. Grant of License (Form MD5): Upon successful completion, the license is issued.

The entire process generally takes 3 to 4 months, assuming timely responses and complete documentation.

Manufacturing License Documents Required for Hand-held Campimeter

To ensure smooth application submission, prepare the following documents:

• Company Constitution Proof: Registration certificates or incorporation documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Qualifications: CVs and certificates of competent personnel
• Fire NOC and Pollution Control NOC: From local authorities
• Device Master File (DMF): Detailed device description, specifications, manufacturing process, risk management, and validation data. Our Device Master File guide can assist in preparation.
• Plant Master File (PMF): Information about manufacturing facility, equipment, and quality controls. Refer to our Plant Master File guide for details.
• Essential Principles Checklist: Compliance with safety and performance requirements
• Risk Management File: Documenting risk analysis and mitigation strategies tailored to the hand-held campimeter. See our Risk Management guide for best practices.
• Test Reports: From CDSCO-approved labs confirming device safety and performance
• Product Labels and Instructions for Use (IFU): In compliance with Indian regulations
• Quality Management System (QMS) Documents: ISO 13485 certification is highly recommended

Import License Process (MD15)

If you intend to import the Hand-held Campimeter, an Import License (MD15) must be obtained from the Central Licensing Authority. This process typically takes 5 to 6 months and requires:

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

Apply via Form MD14 on the CDSCO portal. For detailed guidance, review our Import License guide.

Timeline and Processing Duration

Government Fees and Costs

• Test License (MD13): Approximately Rs. 5,000 (varies by state)
• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product (Hand-held Campimeter counted as one product)
• Product Testing Fees: Charged by testing labs, typically Rs. 20,000 - Rs. 50,000 depending on tests required
• Audit Fees: Payable to the notified body; varies but generally Rs. 30,000 - Rs. 60,000

Budgeting accurately for these costs is crucial. Early engagement with notified bodies can provide clarity on audit fees.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants falter by submitting partial files. We recommend using comprehensive checklists and our Device Master File guide to ensure completeness.
• Delayed Testing Results: Plan well in advance for product testing and select CDSCO-approved labs with good turnaround times.
• Audit Non-Compliance: Pre-audit internal assessments and QMS readiness reviews can prevent adverse observations.
• Query Resolution Delays: Maintain prompt communication with authorities and be prepared with technical clarifications.

Expert Consultation and Support

Navigating CDSCO licensing for a Class A device like the Hand-held Campimeter can be complex, especially for first-time manufacturers or importers. Our consultancy has helped over 500 companies secure licenses efficiently by:

• Providing tailored document templates
• Coordinating with notified bodies and labs
• Conducting mock audits
• Offering regulatory updates and compliance advice

Don’t hesitate to leverage expert support to avoid costly delays.

Getting Started with Your CDSCO License Application

Ready to enter the Indian market? Here’s how to begin:

1. Register on the CDSCO MD Online Portal to create your user account.
2. Initiate your Test License (Form MD13) application immediately to avoid process bottlenecks.
3. Identify and contract with a CDSCO-approved testing laboratory early.
4. Begin compiling your Device Master File and Plant Master File using our detailed guides.
5. Schedule your notified body audit as soon as your test results are available.
6. Maintain ongoing communication with the State Licensing Authority for status updates.

Using a structured project plan and expert guidance, you can achieve CDSCO MD5 licensing for your Hand-held Campimeter within 3 to 4 months, clearing a critical path to market entry.

For personalized support and end-to-end assistance, contact our regulatory experts who specialize in ophthalmology devices and Class A medical device compliance.

By adhering to this roadmap, manufacturers and importers can confidently navigate the CDSCO licensing journey for the Hand-held Campimeter, ensuring regulatory compliance and timely market access in India.