CDSCO License for Perimeter

Introduction to Perimeter and Its Regulatory Importance in India

The Perimeter is a specialized ophthalmic diagnostic instrument designed to assess the peripheral visual field of patients. As a vital tool in diagnosing and monitoring visual impairments such as glaucoma, its accuracy and reliability are paramount. Given its medical significance and patient safety implications, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before manufacturing or importing Perimeter devices in India.

With over 25 years of experience and having supported 500+ companies in securing their CDSCO licenses, we understand the nuances involved in navigating the regulatory framework for medical devices like the Perimeter. This guide provides detailed, actionable insights specific to Class A devices under ophthalmology to help manufacturers and importers streamline their licensing process.

CDSCO Regulatory Framework for Perimeter (Class A Ophthalmic Device)

The CDSCO regulates medical devices through a risk-based classification system, and the Perimeter falls under Class A, the lowest risk category. This classification mandates obtaining an MD5 Manufacturing License for domestic manufacture or an MD15 Import License for imported products.

The regulatory framework ensures that all medical devices conform to the Essential Principles of safety and performance. For Perimeter, compliance with these norms involves rigorous documentation, testing, and audits before license approval.

Risk Classification and License Requirements for Perimeter

• Risk Class: A (Low Risk)
• License Type for Manufacturing: MD5 License (Application Form MD3)
• Issued By: State Licensing Authority
• License Type for Import: MD15 License (Application Form MD14)
• Issued By: Central Licensing Authority

Class A devices like Perimeter require adherence to basic safety and quality standards, and the licensing process is comparatively quicker and less expensive than higher risk classes.

Manufacturing License Process (MD5) for Perimeter

The MD5 license process involves several critical steps:

1. Test License (Form MD13): Apply for a test license through the CDSCO MD Online Portal. This license allows you to manufacture and test the Perimeter device for regulatory compliance. This stage takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing at CDSCO-recognized laboratories to verify compliance with essential principles. Refer to the list of testing laboratories certified for medical device evaluation.

3. Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Quality Management System (QMS) records, risk management files, and labeling.

4. License Application (Form MD3): Submit the manufacturing license application on the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body will conduct a plant audit to verify compliance with regulatory and quality standards. Check the notified bodies list for eligible auditors.

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

7. Grant of MD5 License: Upon successful completion of all steps, the State Licensing Authority issues the MD5 license.

For detailed guidance on MD5 licensing, our MD5 License Guide offers comprehensive insights.

Manufacturing License Documents Required for Perimeter

To ensure a smooth application process, prepare the following documents meticulously:

• Company Constitution/Registration Certificate
• Proof of ownership/rental agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing processes (see our DMF guide)
• Plant Master File (PMF) describing manufacturing infrastructure and quality systems (PMF guide)
• Essential Principles Checklist confirming compliance with Indian regulations
• Risk Management File outlining hazard analysis and mitigation (Risk Management guidance)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified

Import License Process (MD15) for Perimeter

If you plan to import the Perimeter device into India, the MD15 license from the Central Licensing Authority is mandatory. The key steps include:

1. Document Preparation: Gather all required documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate, DMF, PMF, and wholesale license.

2. Application Submission: File the application on the CDSCO MD Online Portal.

3. Queries Handling: Address any queries raised by CDSCO officials.

4. License Grant: Upon satisfactory review, the MD15 import license is granted.

For further details, refer to our Import License Guide.

Import License Documents Required for Perimeter

• Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Quality Management Certificate
• CE Certificate (if applicable)
• Device Master File (DMF)
• Plant Master File (PMF)
• Wholesale Drug License
• Company Constitution/Registration

Timeline and Processing Duration for Perimeter Licensing

Realistically, allow buffer time for unforeseen delays especially in testing and audit stages.

Government Fees and Costs for Perimeter CDSCO License

• MD5 License Fees: Rs. 5000 per application + Rs. 500 per product
• MD15 Import License Fees (Class A): Approximately $1000 per site +$50 per product

These fees are payable through the CDSCO portal during application submission. Budget for additional costs such as notified body audits, testing laboratory fees, and consultancy if applicable.

Common Challenges and Solutions When Licensing Perimeter

• Incomplete Documentation: Missing files such as DMF or risk management reports can delay approval. Solution: Use checklists and expert reviews before submission.

• Testing Delays: Government labs may have backlogs. Solution: Schedule testing early and consider accredited private labs recognized by CDSCO.

• Audit Non-compliance: Infrastructure or QMS gaps may cause audit failures. Solution: Perform internal mock audits and corrective actions in advance.

• Query Resolution Delays: Slow responses to CDSCO queries prolong timelines. Solution: Assign dedicated regulatory personnel to handle communications promptly.

Expert Consultation and Support for Perimeter Manufacturers and Importers

Navigating CDSCO regulations can be complex. With our extensive experience supporting over 500 companies, we provide tailored consulting to:

• Prepare accurate and complete license applications
• Develop DMF, PMF, and risk management files compliant with Indian regulations
• Coordinate with notified bodies and testing labs
• Expedite query resolutions and audit preparations

Our proven track record ensures a smoother licensing journey, minimizing costly delays.

Getting Started with Your CDSCO License Application for Perimeter

1. Classify Your Device: Confirm that Perimeter is Class A under ophthalmology using resources like the Medical Device Classification guide.

2. Register on CDSCO Portal: Create your account on the CDSCO MD Online Portal.

3. Initiate Test License Application: For manufacturing, apply for the MD13 test license immediately to start product testing.

4. Prepare Documentation: Begin compiling your Device Master File, Plant Master File, Essential Principles Checklist, and risk management documentation.

5. Select Testing Laboratory and Notified Body: Choose from the official lists to ensure compliance.

6. Plan Audit and Quality Systems: Ensure your manufacturing site and QMS are audit-ready.

7. Submit Application and Track Progress: Use the online portal’s dashboard to monitor application status.

By following these specific steps and leveraging expert insights, manufacturers and importers can successfully obtain their CDSCO license for the Perimeter device, enabling timely market entry in India’s expanding ophthalmology sector.