CDSCO License for Eikonometer

Comprehensive Guide to CDSCO Licensing for Eikonometer (Class A Ophthalmic Device)

As a trusted regulatory consultancy with over 25 years of experience and having assisted 500+ companies in navigating India's complex medical device regulations, we provide you with an expert roadmap for obtaining your CDSCO license for the Eikonometer. This ophthalmic instrument, used specifically for diagnosing aniseikonia, falls under Class A risk classification as per the CDSCO notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021. Understanding the regulatory framework and license process will empower manufacturers and importers to efficiently enter the Indian market.

CDSCO Regulatory Framework for Ophthalmic Devices like Eikonometer

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. Since the Eikonometer is an ophthalmic device intended for diagnostic use, it is classified as a Class A device, considered low risk. This classification influences the licensing pathway, regulatory oversight, and compliance requirements.

Risk Classification and License Requirements for Eikonometer

• Risk Class: A (Low Risk)
• License Type: MD5 Manufacturing License
• Regulatory Authority: State Licensing Authority

Class A devices like the Eikonometer require an MD5 license, granted by the State Authority. The process includes obtaining a Test License (Form MD13), conducting product testing at government-approved labs, and completing a notified body audit before license issuance.

For more on device classification, refer to our detailed Medical Device Classification guide.

Manufacturing License Process for Eikonometer (MD5 License)

1. Apply for Test License (Form MD13): Initiate by submitting Form MD13 to the State Licensing Authority. This license enables product testing and validation.
2. Product Testing: Get the Eikonometer tested at CDSCO-approved laboratories. Tests typically verify safety, performance, and compliance with essential principles.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) records.
4. Apply for Manufacturing License (Form MD3): Submit Form MD3 along with all required documents.
5. Audit by Notified Body: A notified body will conduct an on-site audit of your manufacturing facility to verify compliance. Check the list of notified bodies for audit assignments.
6. Resolution of Queries: Address any observations or queries raised during audit or by the licensing authority.
7. Grant of License (Form MD5): Once all criteria are met, the MD5 license is issued, authorizing manufacturing of the Eikonometer in India.

Manufacturing License Documents Required

To streamline your application, ensure the following documents are prepared meticulously:

• Company Constitution (e.g., incorporation certificate, partnership deed)
• Proof of Ownership or Lease of Manufacturing Premises
• Qualification and Experience Certificates of Technical Staff
• No Objection Certificates (NOCs) for Fire Safety and Pollution Control
• Device Master File detailing design, components, and specifications (Device Master File Guide)
• Plant Master File describing manufacturing processes and facility (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with MDR 2017
• Risk Management File demonstrating hazard analysis and mitigation (Risk Management)
• Test Reports from CDSCO-approved labs (Testing Laboratories)
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documentation, preferably ISO 13485 certified

Import License Process for Eikonometer (MD15 License)

If you intend to import the Eikonometer, an MD15 Import License granted by the Central Licensing Authority is mandatory. The process includes:

• Compilation of import-specific documents such as Free Sale Certificate, ISO 13485:2016, CE Certificate, and existing manufacturing license.
• Application submission on Form MD14 via the CDSCO MD Online Portal.
• Resolution of queries from CDSCO.
• Approval and issuance of MD15 license.

The import license process typically takes 5-6 months and has higher fees compared to manufacturing licenses.

Timeline and Processing Duration

Planning your timelines carefully can prevent costly delays.

Government Fees and Costs

• Test License (MD13): No separate fee; included in overall process
• MD5 Manufacturing License Application Fee: Rs 5,000 per application
• Product-wise Fee: Rs 500 per product (Eikonometer counts as one product)

Additional costs to budget for include testing fees at government-approved labs, notified body audit charges, and consultancy fees if outsourcing regulatory assistance.

Common Challenges and Solutions

• Incomplete Documentation: Avoid delays by following checklists and templates for Device and Plant Master Files.
• Testing Delays: Schedule lab testing early to account for queue times at approved labs.
• Audit Non-Compliance: Prepare your manufacturing site and QMS rigorously to pass the notified body audit.

Practical tip: Engage with a notified body early in the process to understand audit expectations.

Expert Consultation and Support

Navigating the CDSCO license landscape can be daunting. Our seasoned experts offer tailored consulting services, from documentation drafting to audit preparedness, ensuring a seamless license grant. We have successfully facilitated over 500 CDSCO license applications, including for ophthalmic devices like the Eikonometer.

Getting Started with Your CDSCO License Application

1. Register on the CDSCO MD Online Portal to create your account.
2. Initiate the Test License application (Form MD13) with your preliminary documentation.
3. Engage a CDSCO-approved testing laboratory early to plan sample submission.
4. Prepare your Device and Plant Master Files using expert guides.
5. Schedule a notified body for the audit once testing is complete.
6. Submit the Manufacturing License application (Form MD3) with all documents and test reports.

By following these actionable steps and leveraging our expertise, you can confidently obtain your CDSCO MD5 license for manufacturing the Eikonometer in India and capitalize on the expanding ophthalmic device market.

For detailed guidance on MD5 licensing, see our MD5 License Guide.

We welcome manufacturers and importers to connect with us for personalized regulatory strategy and hands-on support tailored to your Eikonometer licensing journey.