CDSCO License for Colour discrimination tester
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 lamp, used to test a person's ability to differentiate between colours.
Comprehensive Guide to CDSCO Licensing for Colour Discrimination Tester (Class A Ophthalmic Device)
Navigating the regulatory landscape for medical devices in India can be complex, especially for manufacturers or importers of specialized ophthalmic equipment like the Colour Discrimination Tester. With over 25 years of consulting experience and having supported 500+ companies in successful CDSCO licensing, we provide you with an in-depth, practical roadmap tailored for this Class A medical device.
Understanding the Colour Discrimination Tester and Its Regulatory Significance
The Colour Discrimination Tester is an ophthalmic lamp designed to evaluate an individual's ability to differentiate between colors—an essential diagnostic tool in ophthalmology. Classified as a Class A device under the CDSCO framework, it is considered low-risk but still mandates strict compliance with regulatory requirements. The notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021 specifically governs this device category.
Ensuring timely and accurate licensing not only facilitates legal market entry but also builds trust among healthcare providers and patients by confirming product safety and efficacy.
CDSCO Regulatory Framework for Ophthalmic Devices: Class A Colour Discrimination Tester
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. The Colour Discrimination Tester falls under Class A (low risk), which means the manufacturing license is issued by the State Licensing Authority following a detailed evaluation process.
The licensing process revolves around acquiring an MD5 license, which permits the manufacturing of Class A and B devices within India.
Risk Classification and License Requirements for Colour Discrimination Tester
- Risk Class: Class A (Low risk)
- License Type: MD5 Manufacturing License
- Regulatory Authority: State Licensing Authority
- Key Regulation: MDR 2017 & subsequent amendments
Understanding this classification is crucial because it determines the scope of documentation, testing, and audit requirements.
Step-by-Step Manufacturing License Process (MD5) for Colour Discrimination Tester
- Test License Application (Form MD13): Before full manufacturing approval, a test license is mandatory. This preliminary license allows you to produce the device for testing and evaluation.
- Product Testing: Conduct testing of the Colour Discrimination Tester at government-approved laboratories to demonstrate compliance with essential principles.
- Document Preparation: Compile comprehensive technical and quality documents required for the license application.
- Submit MD5 Application (Form MD3): File the manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: The State Licensing Authority will arrange an audit via an approved notified body. Check the list of notified bodies to identify authorized auditors.
- Query Resolution: Address any queries or observations raised during the audit or review process.
- License Grant: Upon successful compliance, the MD5 license is issued.
Documents Required for MD5 Manufacturing License Application
For the Colour Discrimination Tester, the documentation must be thorough. Key documents include:
- Company Constitution or Incorporation Certificate
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board Clearance
- Device Master File (DMF): Detailed technical specifications, design, and manufacturing processes. Our Device Master File guide can assist in preparation.
- Plant Master File (PMF): Details of the manufacturing facility. Refer to our Plant Master File guide for best practices.
- Essential Principles Checklist demonstrating compliance with safety and performance standards
- Risk Management File showcasing hazard analysis and mitigation strategies, aligned with our Risk Management guide
- Test Reports from CDSCO-recognized laboratories (see Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, ideally ISO 13485 certified
Import License Process (MD15) for Colour Discrimination Tester
If you are an importer, obtaining an MD15 import license from the Central Licensing Authority is mandatory. This process generally takes 5-6 months and involves:
- Comprehensive document submission including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate, device and plant master files, and wholesale license.
- Application submission on the CDSCO MD Online Portal.
- Resolving departmental queries.
- Grant of import license.
For detailed guidance on import licensing, our Import License guide offers invaluable insights.
Timeline and Processing Duration
| Process Stage | Timeframe |
|---|---|
| Test License (MD13) Application | 1.5 to 2 months |
| Product Testing | 3 to 4 weeks |
| Document Preparation | 2 to 3 weeks |
| MD5 License Application Processing | 1.5 to 2 months |
| Audit and Query Resolution | 3 to 4 weeks |
| Total Estimated Duration | 3 to 4 months |
Government Fees and Costs
For Class A devices like the Colour Discrimination Tester, the fee structure is as follows:
- Application Fee: INR 5,000 per application
- Product Fee: INR 500 per product
Additional costs may include laboratory testing fees (varies per test), audit charges by notified bodies, and consultancy fees if opting for expert assistance.
Common Challenges and Their Solutions
- Delayed Test Reports: Opt for government-recognized testing labs early and pre-book testing slots.
- Incomplete Documentation: Use detailed checklists for DMF and PMF; consider professional document preparation services.
- Audit Non-compliance: Conduct internal mock audits and gap assessments before official inspections.
- Query Backlogs: Maintain proactive communication with CDSCO officials to expedite responses.
Expert Consultation and Support
Given the nuances of the MDR 2017 and specific requirements for ophthalmic devices, partnering with consultants experienced in CDSCO licensing can significantly reduce time and risk. We have successfully navigated over 500 CDSCO licensing projects, ensuring compliance and timely approvals.
Practical Next Steps to Begin Your CDSCO License Application
- Assess your Device Classification: Confirm the Class A status using the Medical Device Classification guide.
- Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
- Engage Accredited Testing Labs: Schedule testing at CDSCO-recognized labs.
- Compile Required Documentation: Utilize available guides for DMF and PMF creation.
- Prepare for Audit: Contact notified bodies early to schedule audits.
- Submit MD5 License Application: File Form MD3, track progress, and promptly address any queries.
Embarking on this process with a clear roadmap and experienced support enhances your chances of swift license approval, enabling your Colour Discrimination Tester to reach the Indian market compliantly and efficiently.
For more detailed assistance, feel free to reach out to our regulatory experts who can guide you through every step of your CDSCO licensing journey.
