CDSCO License for Pleoptophor
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
An ophthalmic instrument used for the treatment of eccentric eye fixation (casts in the eye) by dazzling the perimacular retina, thereby relatively enhancing the visual capabilities of the fovea.
Comprehensive Guide to CDSCO Licensing for Pleoptophor – Class A Ophthalmic Device
As trusted regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the nuances of navigating the Central Drugs Standard Control Organization (CDSCO) licensing process for medical devices like the Pleoptophor. This ophthalmic instrument, designed for treating eccentric eye fixation by dazzling the perimacular retina, falls under Class A – the lowest risk category – as per the notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.
Our detailed guide will help manufacturers and importers understand the regulatory framework, licensing requirements, timelines, costs, and practical insights to facilitate a smooth market entry in India.
CDSCO Regulatory Framework for Pleoptophor (Class A Ophthalmic Device)
The CDSCO regulates medical devices under the Medical Device Rules (MDR), 2017, categorizing devices into Class A, B, C, and D based on risk. Pleoptophor, as a Class A device, is subject to the least stringent regulatory controls but still requires a manufacturing license (MD5) issued by the State Licensing Authority.
The device’s intended use in ophthalmology for enhancing foveal vision places it under ophthalmic instruments, which are specifically notified under the MDR. Compliance with the Essential Principles of Safety and Performance according to CDSCO guidelines is mandatory.
Risk Classification and License Requirements for Pleoptophor
Class A devices like Pleoptophor require an MD5 manufacturing license. This is applied through Form MD3 on the CDSCO MD Online Portal. The process involves obtaining a test license (Form MD13) initially, product testing from government-approved laboratories, document preparation, followed by an audit from a notified body.
For detailed classification criteria and risk management integration, manufacturers can refer to our Medical Device Classification and Risk Management guides.
Manufacturing License Process (MD5) for Pleoptophor
- Test License (Form MD13): Before applying for MD5, obtain a test license which typically takes 1.5 to 2 months. This permits product testing.
- Product Testing: Conduct testing at CDSCO-approved labs listed on the Testing Laboratories portal. Testing validates conformity with Indian standards.
- Document Preparation: Prepare necessary documents including Device Master File (DMF), Plant Master File (PMF), risk and quality management files.
- Application Submission: Submit application Form MD3 for MD5 license on the CDSCO MD Online Portal.
- Audit: A notified body (from the Notified Bodies List) will conduct an audit of the manufacturing site.
- Query Resolution: Address any queries raised by the CDSCO or the notified body promptly.
- License Grant: On successful audit and query resolution, the MD5 license will be granted.
Manufacturing License Documents Required for Pleoptophor
- Company Constitution and Incorporation Certificate
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File covering design, specifications, and manufacturing process (DMF Guide)
- Plant Master File detailing the manufacturing facility (PMF Guide)
- Essential Principles Checklist demonstrating compliance
- Risk Management File
- Test Reports from government approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation as per ISO 13485
Import License Process (MD15) for Pleoptophor
For importers of the Pleoptophor device, an MD15 license is mandatory. This license is granted by the Central Licensing Authority and does not require a test license. The typical timeline ranges from 5 to 6 months.
Steps include:
- Document preparation including manufacturing license copy, Free Sale Certificate, ISO 13485 certification, CE certificate, Device Master File, Plant Master File, and Wholesale License.
- Submission of the application on the CDSCO MD Online Portal.
- Query resolution and final grant of the MD15 license.
Import License Documents Required
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale license or equivalent
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| Application Processing (MD5) | 1 to 2 months |
| Audit and Query Resolution | 3 to 4 weeks |
| Total Duration | Approximately 3 to 4 months |
The timelines can vary based on the completeness of documentation and responsiveness during queries.
Government Fees and Costs
- MD5 License Application Fee: INR 5,000 per application
- Per Product Fee: INR 500 per product
Additional costs to factor in:
- Testing fees at approved labs
- Fees for audits by notified bodies
- Consultancy or document preparation support if outsourced
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or non-conformance in product testing.
Solution: Engage experts early to prepare robust Device and Plant Master Files. Use checklists to ensure compliance with Essential Principles and risk management.
Challenge: Scheduling and clearing audits by notified bodies.
Solution: Select notified bodies with availability matching your timelines from the Notified Bodies List and prepare your facility proactively.
Challenge: Responding to queries promptly and comprehensively.
Solution: Maintain a dedicated regulatory liaison team and keep all records and test reports well-organized.
Expert Consultation and Support
Our seasoned consultants have guided over 500 companies through the CDSCO licensing maze. We offer:
- Gap analysis of existing documentation
- Preparation of DMF, PMF, and Risk Management files
- Liaison with notified bodies and testing laboratories
- End-to-end application management on the CDSCO MD Online Portal
Getting Started with Your CDSCO License Application for Pleoptophor
- Assess Device Classification: Confirm Pleoptophor’s Class A status and understand applicable rules.
- Prepare Documentation: Utilize our Device and Plant Master File guides to compile robust files.
- Apply for Test License (MD13): Submit your test license application early to avoid delays.
- Coordinate Testing: Engage government-approved labs promptly to get compliant test reports.
- Submit MD5 Application: Upload all documentation and apply via the CDSCO MD Online Portal.
- Prepare for Audit: Schedule audits with notified bodies and ensure your facility meets all requirements.
- Respond to Queries: Address CDSCO and audit queries thoroughly and timely.
- Receive License: Post-approval, begin manufacturing and marketing in India.
By following these actionable steps, manufacturers and importers can confidently navigate the regulatory landscape for Pleoptophor, ensuring timely access to the Indian market while maintaining compliance with CDSCO standards.
For personalized support or to discuss your specific project, reach out to our expert regulatory consultants who bring decades of experience in CDSCO licensing.
We trust this comprehensive guide equips you with the knowledge and confidence to proceed effectively with your Pleoptophor CDSCO license application.
