CDSCO License for Ophthalmic tonometer

Comprehensive Guide to CDSCO Licensing for Ophthalmic Tonometers (Class B Medical Device)

Ophthalmic tonometers play a critical role in eye care by accurately measuring intraocular pressure (IOP), essential for diagnosing and managing glaucoma. Given the device's medical importance and regulatory oversight, securing the correct CDSCO license is mandatory before marketing or manufacturing in India. With over 25 years of experience and having assisted 500+ companies, we offer a detailed, actionable roadmap for obtaining your CDSCO license for ophthalmic tonometers, classified as Class B medical devices under notification Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021.

CDSCO Regulatory Framework for Ophthalmic Tonometers

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India, ensuring safety, efficacy, and quality. Ophthalmic tonometers fall under the ophthalmology category and are classified as Class B devices due to their moderate risk profile. Compliance with the Medical Device Rules, 2017, is mandatory. This includes obtaining a manufacturing license under Form MD5 if you intend to produce the device domestically or an import license under Form MD15 if you plan to import.

Risk Classification and License Requirements for Ophthalmic Tonometers

As a Class B device, ophthalmic tonometers require a manufacturing license known as MD5, issued by the State Licensing Authority. This classification implies moderate risk requiring stringent controls but less regulatory burden compared to Class C or D devices. Understanding this classification helps tailor your compliance approach effectively.

Manufacturing License Process (MD5) for Ophthalmic Tonometers

The MD5 license process can take approximately 3 to 4 months and involves several critical stages:

1. Test License (Form MD13): Initially, you must obtain a test license, which takes about 1.5 to 2 months. This allows the product to be manufactured on a trial basis for testing.

2. Product Testing: Conduct product testing at CDSCO-approved testing laboratories to generate compliance reports. Ensure your device meets all applicable Indian and international standards.

3. Documentation Preparation: Compile comprehensive documents including technical files, quality management system (QMS) evidence, and regulatory checklists.

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

5. Audit by Notified Body: A notified body will conduct an audit of your manufacturing facility and processes. You can check the list of notified bodies authorized for this purpose.

6. Query Resolution: Respond promptly to any queries raised by the CDSCO or notified body to avoid delays.

7. Grant of License (Form MD5): Upon satisfactory audit and documentation, the license is granted.

Manufacturing License Documents Required for Ophthalmic Tonometers

To ensure a smooth application, prepare the following documents meticulously:

• Company Constitution (e.g., Memorandum and Articles of Association)
• Proof of ownership or lease of the manufacturing premises
• Qualification and experience documents of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailing device design, manufacturing processes, and specifications (Device Master File Guide)
• Plant Master File (PMF): Information on manufacturing facility, equipment, and quality control (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with safety and performance requirements
• Risk Management File demonstrating identification and mitigation of potential risks (Risk Management)
• Product Test Reports from CDSCO-approved labs (Testing Laboratories)
• Product labels and Instructions for Use (IFU)
• Quality Management System documents (ISO 13485 certification recommended)

Import License Process (MD15) for Ophthalmic Tonometers

For importers, an MD15 license issued by the Central Licensing Authority is mandatory. The process is more document-intensive and generally takes 5 to 6 months. Key steps include:

• Preparation of all required documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, and others.
• Apply on the CDSCO MD Online Portal using Form MD14.
• Respond to queries from CDSCO promptly.
• Upon successful review, the MD15 import license is granted.

Import License Documents Required

• Valid Manufacturing License of the foreign manufacturer
• Free Sale Certificate from the country of origin
• ISO 13485:2016 Quality Management System Certificate
• CE Certificate or equivalent regulatory approval
• Device Master File and Plant Master File
• Wholesale License (if applicable in India)
• Company Constitution and other administrative documents

Timeline and Processing Duration

For ophthalmic tonometers (Class B), the MD5 manufacturing license process, including the test license and audit, typically spans around 3 to 4 months.

Government Fees and Costs

For MD5 licenses (Class B devices), the fee structure is as follows:

• Application Fee: ₹5,000
• Per Product Fee: ₹500

These fees are payable via the CDSCO portal during submission. Budget for additional costs such as testing fees at government labs, notified body audit fees, and documentation preparation.

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

• Solution: Submit a complete, error-free application with all required attachments. Early engagement with CDSCO officers helps.

Challenge 2: Non-compliance During Audit

• Solution: Conduct thorough internal audits before notified body inspection. Maintain updated QMS and technical files.

Challenge 3: Testing Laboratory Backlogs

• Solution: Pre-schedule testing in CDSCO-approved labs and consider multiple labs to avoid delays.

Challenge 4: Complex Documentation Preparation

• Solution: Use expert consultants and standardized templates for Device Master File and Plant Master File.

Expert Consultation and Support

Navigating CDSCO regulations for ophthalmic tonometers requires deep expertise. Our team, with 25+ years of regulatory experience, has successfully guided over 500 companies through this process. We assist with:

• End-to-end license application
• Documentation drafting and review
• Liaison with CDSCO and notified bodies
• Audit preparation and compliance training

Our proactive approach minimizes delays and ensures your ophthalmic tonometer reaches the Indian market smoothly.

Getting Started with Your CDSCO License Application

1. Assess Your Regulatory Status: Confirm whether you need an MD5 manufacturing license or MD15 import license.

2. Gather Required Documents: Begin compiling your Device Master File, Plant Master File, QMS documents, and technical files.

3. Apply for Test License (If Manufacturing): Submit Form MD13 via the CDSCO MD Online Portal.

4. Plan Product Testing: Schedule testing at CDSCO-approved labs early.

5. Prepare for Audit: Engage with a notified body for audit readiness.

6. Submit MD5 Application: Complete and submit Form MD3 after test license and testing are completed.

7. Engage With Experts: Consider partnering with experienced regulatory consultants to streamline the process.

Embarking on your CDSCO licensing journey with a clear plan and expert support significantly enhances your chances of timely approval. Contact us to leverage our expertise and accelerate your ophthalmic tonometer's market entry in India.