CDSCO License for Orbital depressor
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A hand-held ophthalmic surgical instrument used to displace tissue to facilitate examination of the surrounding area in the orbital cavity during eye surgery.
Comprehensive Guide to CDSCO Licensing for Orbital Depressor (Class A Ophthalmic Device)
As a specialized hand-held ophthalmic surgical instrument designed to displace tissue in the orbital cavity during eye surgery, the Orbital Depressor falls under Class A medical devices in India’s regulatory framework. Given its critical role in ophthalmology, obtaining the appropriate CDSCO license is essential for manufacturers and importers aiming to market this device in India.
With over 25 years of experience and having supported 500+ companies through the licensing process, we provide you with an expert roadmap to secure your CDSCO license smoothly, efficiently, and compliantly.
CDSCO Regulatory Framework for Orbital Depressor
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of all medical devices in India. As per the Medical Device Rules, 2017, the Orbital Depressor is classified as a Class A device due to its low risk profile but still requires a formal manufacturing license for market entry.
The regulatory authority for Class A devices is the State Licensing Authority, and the license type is the MD5 Manufacturing License, applied using Form MD3 via the CDSCO MD Online Portal.
Risk Classification and License Requirements for Orbital Depressor
- Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Regulatory Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months (including test license and audit)
- Fees: ₹5,000 per application + ₹500 per product
Understanding the risk classification is crucial because it dictates the licensing authority, required documentation, fees, and timelines.
Manufacturing License Process for Orbital Depressor (MD5)
The manufacturing license process for Class A devices like the Orbital Depressor involves several structured steps:
Test License Application (Form MD13): Before applying for the MD5 license, you must obtain a test license which allows you to manufacture the device for sample testing. This typically takes 1.5 to 2 months.
Product Testing: Conduct mandatory product testing at CDSCO-recognized government-approved laboratories listed on the Testing Laboratories page. This ensures compliance with essential principles.
Document Preparation: Compile all required documents, including Device Master File (DMF) and Plant Master File (PMF). For comprehensive guidance on DMF and PMF preparation, you can refer to our Device Master File guide and Plant Master File guide.
Application Submission: Submit your application on the CDSCO MD Online Portal using Form MD3.
Audit by Notified Body: After application acceptance, an audit by a notified body is scheduled. You can review the list of notified bodies authorized to conduct MD5 audits.
Query Resolution: Respond promptly to any queries from the department or notified body to avoid delays.
License Grant: Upon successful audit and clearance of queries, the State Licensing Authority grants the MD5 license on Form MD5.
Manufacturing License Documents Required for Orbital Depressor
To ensure a smooth review, prepare the following documents meticulously:
- Company Constitution Documents: Certificate of Incorporation, Memorandum and Articles of Association.
- Proof of Premises Ownership or Lease Agreement: Valid and clear ownership proof of the manufacturing site.
- Technical Staff Credentials: Qualification certificates and experience details of key personnel.
- Fire NOC and Pollution Control Certificate: Compliance with local safety and environmental regulations.
- Device Master File (DMF): Detailed technical specifications and design data.
- Plant Master File (PMF): Description of manufacturing processes, quality control, and infrastructure.
- Essential Principles Checklist: Declaration of compliance with Indian medical device standards.
- Risk Management File: Documented risk analysis and mitigation as per ISO 14971; see our Risk Management guide.
- Test Reports: From government-approved laboratories.
- Labels and Instructions for Use (IFU): Patient/user information in compliance with regulatory norms.
- Quality Management System Documents: ISO 13485:2016 certification and internal SOPs.
Import License Process for Orbital Depressor (MD15)
Although this guide focuses on manufacturing, importers of the Orbital Depressor must apply for an MD15 import license through the Central Licensing Authority.
Key points:
- Application Form: MD14
- No test license required
- Processing duration: 5-6 months
- Required documents include the manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, Wholesale License, and company constitution documents.
- Fees vary based on device class; for Class A devices, fees are approximately 50 per product.
For detailed steps, consult our Import License guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License Application | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 4 weeks |
| Application Processing & Audit | 1 – 1.5 months |
| Total Estimated Time | 3 – 4 months |
Planning your project timeline with these realistic durations helps avoid unexpected delays.
Government Fees and Costs
- Test License (MD13): No separate fee; included in application process
- MD5 License Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
- Audit and Testing Charges: Vary based on notified body and testing lab rates
Budgeting accurately for these fees ensures smooth financial planning.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all files, especially DMF, PMF, and Risk Management files, are detailed and fully compliant.
- Delayed Test Lab Reports: Choose government-approved labs with proven turnaround times; early booking is advisable.
- Audit Non-Compliance: Pre-audit internal checks and mock audits can prepare your team and facility effectively.
- Slow Query Resolution: Maintain a dedicated regulatory liaison to respond promptly to department communications.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our 25+ years of regulatory consultancy experience has helped over 500 companies overcome these hurdles. We offer:
- Customized gap analysis and documentation assistance
- Coordination with notified bodies and testing labs
- End-to-end application filing and follow-up
- Training on regulatory compliance and QMS implementation
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm the Orbital Depressor’s Class A status via official resources.
- Prepare Test License Application (Form MD13): Begin the process on the CDSCO MD Online Portal.
- Initiate Testing with Approved Labs: Schedule product testing early to avoid bottlenecks.
- Develop Complete Documentation: Use our detailed guides to assemble your DMF, PMF, and Risk Management files.
- Submit MD5 License Application (Form MD3): Once test reports and documentation are ready.
- Plan for Audit and Query Resolution: Engage with a notified body and prepare your site accordingly.
Starting early and following this structured approach significantly improves your chances of timely license approval.
For detailed support tailored to your Orbital Depressor device, contact our regulatory experts today and leverage our proven track record in CDSCO licensing success.
