CDSCO License for Orbital rim prosthesis
Medical Device Information
Intended Use
An implantable ocular device used to reconstruct the floor of the bony cavity that contains the eyeball and its associated muscles, vessels, and nerves and is intended to house an artificial eye.
Comprehensive Guide to CDSCO Licensing for Orbital Rim Prosthesis (Class C Medical Device)
Orbital rim prostheses are specialized implantable ocular devices critical in reconstructive ophthalmology. Designed to restore the bony floor of the eye socket and support an artificial eye, these Class C devices demand stringent regulatory compliance before entering the Indian market. With over 25 years of experience and helping 500+ companies navigate CDSCO licensing, we provide a detailed, practical roadmap tailored for manufacturers and importers of this device.
Understanding the CDSCO Regulatory Framework for Orbital Rim Prosthesis
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Ministry of Health and Family Welfare. The regulatory framework mandates licensing based on risk classification, device category, and intended use. Since the orbital rim prosthesis is a Class C implantable device in the ophthalmology category, it falls under the Central Licensing Authority’s purview.
Key Notification: Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021 specifically covers this device.
Risk Classification and License Requirements for Orbital Rim Prosthesis
- Risk Class: C (High moderate risk)
- License Type for Manufacturing: MD9 License (Form MD7)
- License Type for Import: MD15 License (Form MD14)
Class C devices require stringent evaluation due to their implantable nature and critical function. The MD9 manufacturing license is issued by CDSCO's Central Licensing Authority, while the MD15 import license is also centrally granted.
For detailed classification insights, manufacturers can refer to our Medical Device Classification guide.
Manufacturing License Process for Orbital Rim Prosthesis (MD9 License)
- Test License Application (MD13): Initiate by applying for a test license on Form MD13. This license allows manufacturing for testing and evaluation.
- Product Testing: Obtain mandatory testing of the orbital rim prosthesis from CDSCO-approved government laboratories. Refer to the list of testing laboratories for accredited centers.
- Document Preparation: Compile comprehensive technical documents, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles Checklist.
- License Application (MD7): Submit the manufacturing license application through the CDSCO MD Online Portal using Form MD7.
- Audit and Inspection: CDSCO inspectors conduct a rigorous audit of manufacturing facilities and quality systems.
- Query Resolution: Address any queries or additional data requests promptly.
- License Grant: Upon satisfactory compliance, the MD9 license is granted.
For more details on the MD9 process, consult our MD9 License Guide.
Manufacturing License Documents Required
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Documents of Technical Staff
- Fire Safety and Pollution Control NOCs
- Device Master File (DMF) detailing design, specifications, and clinical data (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing processes and quality controls (Plant Master File Guide)
- Essential Principles Checklist for compliance with Indian medical device standards
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Test Reports from CDSCO-approved labs
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485 certificates)
Import License Process for Orbital Rim Prosthesis (MD15 License)
- Document Compilation: Gather all requisite documents, including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, DMF, PMF, and wholesale license.
- License Application: Submit Form MD14 application for import license via the CDSCO MD Online Portal.
- Evaluation and Queries: CDSCO reviews the application and may raise queries.
- License Grant: After satisfactory review, the MD15 import license is issued.
Detailed procedural steps are outlined in our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Quality Management System Certificate
- CE Certificate or equivalent international certification
- Device Master File and Plant Master File
- Wholesale License in India
- Company Constitution and business proof
Timeline and Processing Duration
| License Type | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| MD9 Manufacturing | 4 - 5 months (including test) |
| MD15 Import License | 5 - 6 months |
The MD9 manufacturing process encompasses test license issuance, product testing, audit, and final licensing. Import licenses (MD15) take slightly longer due to comprehensive document verification.
Government Fees and Costs
| License Type | Fees |
|---|---|
| MD9 Manufacturing | Rs. 50,000 per application + Rs. 1,000 per product |
| MD15 Import | Classes C/D: 1,500 per product |
Additional costs include laboratory testing fees, audit fees payable to notified bodies, and consultancy charges if outsourced.
Common Challenges and Solutions
- Delayed Testing: Testing in government labs may get delayed; proactive scheduling and follow-up with labs listed on the CDSCO Testing Laboratories portal is essential.
- Documentation Gaps: Incomplete Device or Plant Master Files can stall approval. Utilize professional templates and refer to our detailed guides.
- Audit Non-compliance: Facilities unprepared for notified body audits risk rejection. Conduct pre-audit internal assessments.
- Query Management: Timely and clear responses to CDSCO queries accelerate approval.
Expert Consultation and Support
With over 25 years of regulatory consulting experience, we assist clients in:
- Preparing comprehensive technical dossiers
- Coordinating product testing and audit readiness
- Managing application filings via the CDSCO MD Online Portal
- Navigating complex queries and compliance nuances
Getting Started with Your CDSCO License Application for Orbital Rim Prosthesis
- Assess Device Classification: Confirm your device’s Class C status and review regulatory requirements.
- Prepare Technical Documentation: Develop or update your Device Master File and Plant Master File.
- Apply for Test License (MD13): Initiate manufacturing for testing purposes.
- Coordinate Product Testing: Engage CDSCO-approved laboratories early.
- Compile Complete Application: Organize all documents as per MD9 or MD15 requirements.
- Submit Application via CDSCO Portal: Use the official CDSCO MD Online Portal for application submission.
- Plan for Audit: Prepare your manufacturing site and QMS for CDSCO inspection.
Embarking on CDSCO licensing for orbital rim prostheses can be complex but manageable with expert guidance. Contact us to streamline your application and accelerate your market entry in India.
For further reading and resources, explore our specialized guides on MD9 Licensing and Device Master Files.
