CDSCO License for Nystagmus inducing tape

Comprehensive Guide to CDSCO Licensing for Nystagmus Inducing Tape (Class A Ophthalmic Device)

As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the nuances and specific requirements for medical devices like the Nystagmus Inducing Tape. This ophthalmic device, designed to elicit optokinetic nystagmus for blindness testing, falls under Class A risk classification per CDSCO Notification Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021.

Navigating the regulatory framework to obtain your manufacturing or import license can be complex. This detailed guide provides practical, actionable insights tailored for your device type and risk class.

CDSCO Regulatory Framework for Nystagmus Inducing Tape

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules 2017. The Nystagmus Inducing Tape is categorized under ophthalmic devices, specifically for diagnostic use, and classified as Class A (low risk). Compliance with CDSCO ensures your device meets safety, quality, and efficacy standards necessary for Indian market access.

Risk Classification and License Requirements

According to the Medical Device Rules, Class A devices like the Nystagmus Inducing Tape require an MD5 manufacturing license issued by the State Licensing Authority. The process involves obtaining a test license (MD13), product testing by government-approved labs, and a notified body audit.

For detailed classification criteria, manufacturers can refer to the Medical Device Classification guide.

Manufacturing License Process (MD5 License)

The MD5 license process for Class A devices involves the following steps:

1. Test License Application (Form MD13): Initially, you must apply for a test license to manufacture the device for testing purposes. This step takes approximately 1.5 to 2 months.

2. Product Testing: Post-test license approval, your product samples must be tested at CDSCO-recognized laboratories. Refer to the list of government-approved testing laboratories to select an appropriate facility.

3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents.

4. Application for Manufacturing License (Form MD3): Submit your application for the MD5 license through the CDSCO MD Online Portal.

5. Notified Body Audit: Your manufacturing facility will undergo an audit by a notified body. The notified bodies authorized for Class A/B audits can be found on the Notified Bodies List.

6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.

7. Grant of License: Upon satisfactory compliance, the state authority issues the MD5 manufacturing license in Form MD5.

Manufacturing License Documents Required

To streamline your application, ensure you have the following documents ready:

• Company Constitution/Registration Certificate
• Proof of ownership or lease agreement of the manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) detailing design and specifications. Our Device Master File guide can assist you in preparation.
• Plant Master File describing manufacturing processes. Learn how to create one easily in our Plant Master File guide.
• Essential Principles Checklist affirming compliance with safety and performance requirements
• Risk Management File documenting hazard analyses and mitigation strategies (see our Risk Management guide)
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU) complying with CDSCO standards
• Quality Management System (QMS) documentation, including ISO 13485:2016 certification if applicable

Import License Process (MD15 License)

For importers of Nystagmus Inducing Tape, the MD15 import license is issued by the Central Licensing Authority. The process typically takes 5-6 months and does not require a test license.

The steps involve comprehensive document preparation, submission of the application on the CDSCO portal, query resolution, and eventual license grant on Form MD15.

Refer to our detailed Import License guide for more information.

Import License Documents Required

Documents required include:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 and CE Certificates
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution and other company credentials

Timeline and Processing Duration

Planning your regulatory strategy with these timelines in mind helps avoid costly delays.

Government Fees and Costs

For the Nystagmus Inducing Tape as a Class A device, the fee structure for the manufacturing license is:

• Application Fee: Rs 5,000 per application
• Product Fee: Rs 500 per product

This fee covers the entire process including the notified body audit. Import license fees vary by risk class and product count.

Common Challenges and Solutions

Challenge 1: Delays in test license approval and product testing

• Solution: Engage early with notified bodies and testing laboratories to schedule audits and testing slots. Maintain clear communication and ensure submission of complete documentation to avoid back-and-forth delays.

Challenge 2: Incomplete or inconsistent documentation

• Solution: Use standardized templates for Device Master File and Plant Master File. Our guides offer practical frameworks to prepare compliant documents.

Challenge 3: Queries during audit or evaluation

• Solution: Prepare a dedicated regulatory team to respond promptly with accurate information. Proactive risk management documentation reduces audit queries.

Challenge 4: Understanding and complying with labeling and IFU requirements

• Solution: Follow CDSCO labeling guidelines closely and incorporate patient-friendly IFU.

Expert Consultation and Support

Navigating CDSCO licensing for a specialized device like the Nystagmus Inducing Tape demands expertise. Our consultancy has successfully guided over 500 companies through the MD5 licensing process, ensuring timely approvals and compliance.

We provide end-to-end support including:

• Regulatory gap analysis
• Document preparation and review
• Liaison with notified bodies and government authorities
• Audit preparation and compliance training

Getting Started with Your CDSCO License Application

To initiate your licensing journey:

1. Register on the CDSCO MD Online Portal to gain access to application forms and status tracking.

2. Compile your test license application (Form MD13) with all requisite documents as outlined above.

3. Select a government-approved testing laboratory early to avoid scheduling bottlenecks.

4. Prepare your Device Master File and Plant Master File using expert templates.

5. Plan for the notified body audit by reviewing the list of Notified Bodies authorized for Class A devices.

6. Engage with a regulatory consultant to streamline the process, avoid common pitfalls, and meet all requirements efficiently.

Embarking on your CDSCO license application with a clear roadmap and expert guidance will position your Nystagmus Inducing Tape for successful market entry in India. Contact us to leverage our extensive experience and ensure a smooth regulatory journey.