CDSCO License for Fresnel prism
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 device intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction.
Comprehensive Guide to CDSCO Licensing for Fresnel Prism (Class A Ophthalmic Device)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we understand the unique challenges and nuances involved in bringing ophthalmic devices like the Fresnel prism to the Indian market. This guide will walk you through the regulatory framework, risk classification, licensing process, documentation, costs, and practical tips tailored specifically to Fresnel prisms—a Class A medical device used for managing strabismus or other eye muscle dysfunction.
Understanding the Fresnel Prism and Its Regulatory Importance
A Fresnel prism is a thin, lightweight device applied to spectacle lenses to create a prismatic effect, often prescribed to correct binocular vision disorders such as strabismus. Given its direct impact on vision correction and patient safety, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) ensures these devices meet quality, safety, and efficacy standards before market entry.
CDSCO Regulatory Framework for Fresnel Prism
Under the Medical Device Rules, 2017, which came into effect on January 1, 2018, the Fresnel prism falls within the ophthalmology category and is classified as a Class A device (low risk). This classification is confirmed by Notification Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021.
Class A devices are regulated primarily by the State Licensing Authority, which simplifies the approval process but still demands compliance with stringent quality and safety norms.
Risk Classification and License Requirements for Fresnel Prism
- Risk Class: A (Low Risk)
- Applicable License: MD5 Manufacturing License (Application Form MD3)
- Regulatory Authority: State Licensing Authority
The MD5 license is mandatory for manufacturing Fresnel prisms within India. For importers, the MD15 import license (granted by the Central Licensing Authority) is required.
Manufacturing License Process (MD5) for Fresnel Prism
The MD5 license process involves several critical stages:
Test License (Form MD13): Before manufacturing, you must obtain a test license that allows sample production for testing purposes. This takes approximately 1.5 to 2 months.
Product Testing: Conduct product testing at CDSCO-approved government laboratories. For Fresnel prisms, tests include verifying prismatic power, optical clarity, biocompatibility, and compliance with essential principles.
Documentation Preparation: Compile all necessary documents, including Device Master File and Plant Master File.
Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will conduct an on-site audit of the manufacturing facility. Refer to the List of Notified Bodies for authorized auditors.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
License Grant (Form MD5): Upon satisfactory audit and documentation, the manufacturing license is granted.
Manufacturing License Documents Required for Fresnel Prism
To ensure a smooth application process, prepare the following:
- Company Constitution: Certificate of incorporation, partnership deed, or proprietorship declaration.
- Proof of Ownership or Lease of Premises: Valid documentation establishing your manufacturing site.
- Technical Staff Details: Qualification and experience documents of key personnel involved in manufacturing.
- Fire NOC and Pollution Control NOC: Safety and environmental compliance certificates.
- Device Master File (DMF): Comprehensive technical details of the Fresnel prism device. Our Device Master File guide offers in-depth instructions.
- Plant Master File (PMF): Details of manufacturing processes and quality controls. Refer to our Plant Master File guide.
- Essential Principles Checklist: Compliance matrix aligning device features with regulatory standards.
- Risk Management File: Documentation of risk assessment and mitigation strategies. Learn more about effective Risk Management.
- Test Reports: Laboratory testing certificates proving compliance.
- Labels and Instructions for Use (IFU): Samples of product labeling and user instructions.
- Quality Management System (QMS) Documents: ISO 13485 certification and SOPs.
Import License Process (MD15) for Fresnel Prism
For companies importing Fresnel prisms, an MD15 import license from the Central Licensing Authority is essential. The process includes:
Document Preparation: Assemble all required documents such as manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission (Form MD14): Submit your import license application via the CDSCO MD Online Portal.
Query Resolution: Respond promptly to any clarifications sought.
License Grant (Form MD15): The import license is granted typically within 5-6 months.
Import License Documents Required for Fresnel Prism
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| License Type | Approximate Duration | Key Steps Included |
|---|---|---|
| MD5 Manufacturing | 3-4 months | Test license (1.5-2 months), testing, audit |
| MD15 Import | 5-6 months | Document review, application processing |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class A Device) | Rs 5,000 | Rs 500 |
| MD15 Import (Class A) | $1,000 per site | $50 per product |
Note: Fees are subject to change; always verify during application.
Common Challenges and Practical Solutions
Delayed Test Reports: Testing delays can bottleneck your timeline. To avoid this, book slots early at approved labs listed here.
Incomplete Documentation: Missing or inconsistent documents are common reasons for query generation. We recommend using detailed checklists and professional document review before submission.
Audit Non-Compliance: Ensure your facility strictly follows ISO 13485 and GMP guidelines to pass the notified body audit without issues.
Query Resolution Delays: Assign dedicated personnel to monitor and respond to CDSCO communications promptly.
Expert Consultation and Support
Navigating CDSCO licensing for Fresnel prisms can be complex. Our team, with a proven track record of over 500 successful licenses, offers:
- Tailored regulatory strategy
- Comprehensive document preparation
- Liaison with notified bodies and CDSCO authorities
- Audit readiness support
- Post-license compliance advisory
Getting Started with Your CDSCO License Application
To initiate your Fresnel prism licensing process:
Determine your role: Are you a manufacturer or importer? This defines your license type (MD5 or MD15).
Register on the CDSCO MD Online Portal: Create and maintain your account for all submissions.
Prepare your test license application (Form MD13) if manufacturing: Begin early to accommodate testing and audit timelines.
Engage with a notified body early: Select from the official list of notified bodies to schedule your audit.
Compile your Device and Plant Master Files: Use our expert guides to ensure completeness and compliance.
Plan for fees and budget accordingly: Allocate resources for application and per product fees.
Maintain open communication: Promptly respond to CDSCO queries to avoid delays.
By following these actionable steps and leveraging our expertise, your Fresnel prism can reach the Indian market efficiently and compliantly. For personalized assistance, consult with our regulatory experts who have successfully guided numerous ophthalmic device manufacturers through the CDSCO licensing journey.
