CDSCO License for Epiretinal/inner limiting membrane scraper
Medical Device Information
Intended Use
A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses.
Comprehensive Guide to CDSCO Licensing for Epiretinal/Inner Limiting Membrane Scraper (Class B Medical Device)
As a specialized surgical instrument used during delicate posterior segment ophthalmic surgeries, the Epiretinal/Inner Limiting Membrane (ILM) Scraper falls under Class B risk classification according to CDSCO regulations. Designed as a hand-held manual device for lifting membranes like the ILM and epiretinal membrane (ERM), this instrument demands rigorous regulatory compliance to ensure safety and performance in the Indian market.
With over 25 years of experience helping 500+ medical device companies successfully navigate CDSCO licensing, we understand the nuances involved in obtaining the right approvals for such devices. This guide provides a clear, actionable roadmap to secure your manufacturing or import license efficiently.
CDSCO Regulatory Framework for Epiretinal/ILM Scraper
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Following the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9th August 2021, the Epiretinal/ILM Scraper is categorized under the Ophthalmology device class and classified as a Class B device.
Class B devices are considered low to moderate risk, requiring a manufacturing license (MD5) from the State Licensing Authority and adherence to comprehensive quality management and safety protocols.
Risk Classification and License Requirements
- Risk Class: B
- License Type: MD5 Manufacturing License (Form MD3)
- Regulatory Authority: State Licensing Authority
- Licensing Process Duration: Approximately 3-4 months including testing and audit
For importers, the process involves obtaining an MD15 import license from the Central Licensing Authority.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license process is a multi-step journey:
- Test License (Form MD13): Before applying for the MD5 license, manufacturers must obtain a test license, valid for 6 months, which allows sample testing.
- Product Testing: Conduct testing at government-approved laboratories to verify compliance with essential safety and performance standards. Check the list of CDSCO-approved testing laboratories for recognized centers.
- Document Preparation: Compile necessary documentation, including Device Master File, Plant Master File, Technical Files, and Quality Management System (QMS) evidence.
- Application Submission: Submit the MD5 application (Form MD3) via the CDSCO MD Online Portal.
- Audit by Notified Body: An audit by a notified body approved by CDSCO is mandatory. Refer to the list of notified bodies to select an auditor.
- Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
- License Grant: Upon successful audit and document verification, the MD5 license is granted.
Manufacturing License Documents Required for Epiretinal/ILM Scraper
To avoid delays, ensure all documents are complete and accurate:
- Company Constitution (e.g., Memorandum and Articles of Association)
- Proof of ownership or lease agreement of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF): Detailed design, manufacturing process, and specifications. Our Device Master File guide can help streamline this.
- Plant Master File (PMF): Documentation of manufacturing facilities and quality controls. Learn more from our Plant Master File guide.
- Essential Principles Checklist aligned with MDR 2017
- Risk Management File demonstrating compliance with ISO 14971 principles. See our Risk Management guide for best practices.
- Test Reports from government-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Import License Process (MD15) for Epiretinal/ILM Scraper
If you are an importer, the MD15 license is mandatory to legally import Class B devices:
- Application Form: MD14
- Authority: Central Licensing Authority (CDSCO HQ)
- Timeline: 5-6 months
- Process: No test license required; however, detailed documentation must be submitted upfront.
Required documents include:
- Valid manufacturing license from country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale drug license
- Company Constitution documents
Submit your application through the CDSCO MD Online Portal.
Timeline and Processing Duration
| License Type | Approximate Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months (depends on lab) |
| MD5 Manufacturing License | 3 to 4 months total (including above) |
| MD15 Import License | 5 to 6 months |
Efficient document preparation and swift response to queries can reduce these timelines.
Government Fees and Costs
For Class B devices like the Epiretinal/ILM Scraper, expect the following fees:
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs include:
- Testing laboratory fees (varies by lab and tests required)
- Notified body audit fees
- Consultancy fees if opting for expert assistance
Common Challenges and Solutions in CDSCO Licensing
- Incomplete Documentation: Missing or inconsistent files lead to delays. Use detailed checklists and cross-verify documents.
- Testing Delays: Government labs can have backlogs; consider pre-planning and selecting labs with shorter lead times.
- Audit Non-Compliance: Prepare for audits by conducting internal pre-audits and ensuring QMS adherence.
- Query Resolution Delays: Assign a dedicated regulatory officer to respond promptly to queries.
Expert Consultation and Support
Navigating the CDSCO licensing process for ophthalmic surgical instruments can be complex. Our team has supported over 500 companies in acquiring timely approvals for devices like the Epiretinal/ILM Scraper. We offer:
- End-to-end regulatory strategy planning
- Document preparation and review
- Coordination with notified bodies and testing labs
- Audit support and gap analysis
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class B status via the Medical Device Classification guide.
- Prepare Technical Documentation: Compile Device Master File and Plant Master File.
- Apply for Test License (MD13): Submit via the CDSCO MD Online Portal.
- Schedule Product Testing: Engage with approved labs early.
- Engage a Notified Body for Audit: Select from the official list of notified bodies.
- Submit MD5 Application (Form MD3): Once testing and documentation are ready.
- Respond to Queries Promptly: Maintain open communication with CDSCO officials and auditors.
Embarking on your licensing journey with a clear plan helps ensure compliance and timely market entry. Contact us today to leverage our expertise in securing your MD5 manufacturing license for your Epiretinal/ILM Scraper and other ophthalmic surgical devices.
