CDSCO License for Paediatric strabismus screening scanner
Medical Device Information
Intended Use
An electrically-powered optic device designed for screening for strabismus and amblyopia risk in children (aged 2 to 8 years) by using retinal reflections of polarized laser light to/from both eyes simultaneously. It consists of a self-contained unit which includes a visually enticing interface for the child to look at, and provides a result, in the form of a recommendation for referral to an ophthalmologist, if an abnormality is detected.
Comprehensive Guide to CDSCO Licensing for Paediatric Strabismus Screening Scanner (Class B Medical Device)
Introduction: Understanding the Paediatric Strabismus Screening Scanner and Its Regulatory Importance
The Paediatric Strabismus Screening Scanner is an advanced, electrically-powered optic device specifically designed to screen children aged 2 to 8 years for strabismus and amblyopia risk. Utilizing polarized laser light reflections to simultaneously assess both eyes, it provides critical early detection and referral recommendations to ophthalmologists. Given its pediatric application and safety considerations, this device falls under Class B risk classification, making regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) mandatory for market authorization in India.
Navigating the CDSCO licensing process is crucial to ensure that your device meets stringent safety, quality, and efficacy standards, thereby facilitating smooth market entry and sustained business growth. With over 25 years of experience and having assisted 500+ companies, we provide precise guidance tailored to this device category.
CDSCO Regulatory Framework for Paediatric Medical Devices
The CDSCO regulatory framework mandates that medical devices, including pediatric diagnostic devices like the strabismus screening scanner, adhere to classification, licensing, and quality management protocols. The device is notified under File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, placing it within the pediatric and neonatology category.
The regulatory oversight involves multiple stages, including documentation, testing, audit, and final license grant. For your Class B device, the applicable license is the MD5 Manufacturing License, issued by the respective State Licensing Authority.
Risk Classification and License Requirements for Class B Devices
According to CDSCO's classification:
- Class A and B devices are considered low to moderate risk.
- Class B devices, like the paediatric strabismus screening scanner, require an MD5 license for manufacturing.
You can verify your device classification via the Medical Device Classification guide.
License Type: MD5 (Application Form MD3)
Authority: State Licensing Authority
Typical Timeline: 3 to 4 months (including test license and audit)
Cost: INR 5,000 per application + INR 500 per product
Manufacturing License Process (MD5) for Paediatric Strabismus Screening Scanner
The MD5 license process for your Class B device follows a defined sequence:
Test License (Form MD13): Before manufacturing license application, obtain a test license valid for 2 years. This typically takes 1.5 to 2 months to process.
Product Testing: Submit the device to government-approved testing laboratories to validate compliance with safety and performance standards. A list of approved testing laboratories is available on the CDSCO portal.
Documentation Preparation: Compile all necessary technical files, quality management documents, and regulatory paperwork.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts a detailed audit of your manufacturing facility and quality systems. Check the list of notified bodies for approved auditors.
Query Resolution: Address any observations or queries issued by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon satisfactory compliance, the State Licensing Authority issues the MD5 license.
For detailed guidance, refer to our MD5 License Guide.
Manufacturing License Documents Required
To streamline your application for the paediatric strabismus screening scanner, prepare the following documents:
- Company Constitution Documents: Certificate of incorporation, partnership deed, or equivalent.
- Proof of Ownership or Lease of Manufacturing Premises: Utility bills, lease agreements.
- Technical Staff Details: Qualifications and experience certificates of qualified personnel.
- Fire NOC and Pollution Control NOC: From local authorities.
- Device Master File (DMF): Detailed design, manufacturing, and testing information. Our comprehensive Device Master File guide provides insights.
- Plant Master File (PMF): Description of manufacturing facilities and processes. Learn more in our Plant Master File guide.
- Essential Principles Checklist: Compliance with CDSCO essential principles.
- Risk Management File: Documentation of risk analysis, mitigation, and control measures. See our Risk Management resource.
- Test Reports: From CDSCO-approved laboratories.
- Labels and Instructions for Use (IFU): Clear, child-friendly, and regulatory-compliant.
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and associated procedures.
Import License Process (MD15) for Paediatric Strabismus Screening Scanner
If you plan to import this device into India, an MD15 import license is mandatory. The process is governed centrally and typically takes 5 to 6 months.
Key steps include:
Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: Apply on the CDSCO MD Online Portal.
Query Resolution: Address any departmental queries promptly.
License Grant: Issuance of MD15 license.
Import license costs vary by device class; for Class B devices, expect approximately INR 2000 per site and INR 1000 per product.
For comprehensive steps, consult our Import License Guide.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale license for import and distribution
- Company Constitution documents
Timeline and Processing Duration
| Process Stage | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 4 – 6 weeks |
| Documentation Prep | 2 – 3 weeks |
| License Application | Immediate upon prep |
| Audit & Inspection | 4 – 6 weeks |
| Query Resolution | 2 – 3 weeks |
| Final License Grant | Within 1 week post audit |
Total: Approximately 3 to 4 months for the MD5 manufacturing license.
Government Fees and Costs
- MD5 Manufacturing License: INR 5,000 per application + INR 500 per product
- Test License (MD13): Nominal fee as per state regulations
- Product Testing: Varies by laboratory and test scope, typically INR 50,000 to INR 1,00,000
- Audit Fees: Included in licensing fees; notified bodies may charge separately for audits
Common Challenges and Solutions
Challenge 1: Delays in Product Testing Solution: Engage early with CDSCO-approved testing laboratories and schedule tests proactively.
Challenge 2: Incomplete Documentation Solution: Use detailed checklists and expert consultation to ensure all files (DMF, PMF, risk management) are complete and compliant.
Challenge 3: Audit Non-Compliance Solution: Conduct internal audits and mock inspections before the notified body audit.
Challenge 4: Query Resolution Delays Solution: Maintain open communication with CDSCO officials and respond promptly with complete information.
Expert Consultation and Support
Our team has successfully guided over 500 manufacturers and importers through CDSCO licensing for pediatric devices, including the paediatric strabismus screening scanner. We offer:
- Gap analysis and readiness assessment
- Documentation preparation and review
- Coordination with notified bodies and testing labs
- Audit preparation and support
- Prompt query resolution
Partnering with experienced consultants significantly reduces approval timelines and mitigates compliance risks.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class B status via the CDSCO guidelines.
- Prepare Your Documentation: Begin assembling the Device Master File, Plant Master File, risk management, and QMS documents.
- Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with government-approved labs early.
- Identify a Notified Body: Select from the list of notified bodies for the audit.
- Submit MD5 Application: Once testing and documentation are complete, apply via the portal.
- Prepare for Audit: Conduct internal reviews and ensure compliance.
Starting early and following a methodical approach can ensure your paediatric strabismus screening scanner enters the Indian market efficiently and compliantly. For personalized support and detailed guidance, feel free to reach out to our expert regulatory team.
For more information and assistance, visit the CDSCO MD Online Portal and explore our comprehensive guides on device master files, risk management, and licensing.
