CDSCO License for Automated lensmeter(Dioptometer)

Introduction to Automated Lensmeter (Dioptometer) and Its Regulatory Importance

Automated Lensmeters, also known as Dioptometers, are critical ophthalmic instruments used to measure the focusing power and optical properties of spectacle lenses, contact lenses, and prisms. This device plays a vital role in ensuring accurate prescriptions and optimal vision correction. Given its direct impact on eye care, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory before marketing or manufacturing in India.

At our firm, with over 25 years of experience and successful licensing of 500+ medical device companies, we understand the nuances involved in obtaining the right approvals for Class A ophthalmic devices like Automated Lensmeters. This guide will provide you with detailed, actionable steps to navigate the CDSCO licensing framework effectively.

CDSCO Regulatory Framework for Automated Lensmeter (Class A)

Automated Lensmeters fall under Class A medical devices as per the CDSCO classification system, referencing the Medical Device Classification. Class A devices are considered low risk, but they still require strict adherence to licensing, quality assurance, and manufacturing standards.

The relevant notification for this device category is Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021, which formally includes Automated Lensmeters under regulated ophthalmic devices. Compliance with this notification ensures legal marketing and smooth customs clearance in India.

Risk Classification and License Requirements for Automated Lensmeter

As a Class A device, an Automated Lensmeter requires an MD5 manufacturing license granted by the State Licensing Authority. This is governed under Form MD3 for application and results in an MD5 license issuance.

Key points:

• Risk Class: A (Low risk)
• License Type: MD5 (Manufacturing)
• Licensing Authority: State CDSCO Licensing Authority
• Typical timeline: 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

The MD5 license process is tailored for low-risk devices and involves product testing, documentation, and notified body audits.

Manufacturing License Process for Automated Lensmeter (MD5 License)

1. Test License (Form MD13): Initially, obtain a test license valid for 3-6 months. This allows you to manufacture limited quantities for testing purposes.
2. Product Testing: Submit your Automated Lensmeter for testing at CDSCO approved testing laboratories. Testing typically includes accuracy, safety, and performance parameters.
3. Document Preparation: Prepare comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
4. Application Submission (Form MD3): File your application for the MD5 license through the CDSCO MD Online Portal.
5. Audit by Notified Body: Coordinate with a CDSCO notified body for a mandatory audit of your manufacturing site and QMS compliance.
6. Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
7. License Grant (Form MD5): Upon successful audit and documentation review, the MD5 manufacturing license will be granted.

Manufacturing License Documents Required for Automated Lensmeter

To ensure a smooth application process, gather the following documents:

• Company Constitution (Certificate of Incorporation, Memorandum & Articles of Association)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualification Certificates of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) outlining design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) detailing infrastructure, equipment, and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming compliance with Safety and Performance Standards
• Risk Management File demonstrating hazard analysis and mitigation strategies (Risk Management)
• Test Reports from approved laboratories
• Labels and Instructions for Use (IFU) complying with CDSCO labeling norms
• Quality Management System (QMS) documents, preferably ISO 13485:2016 certification or equivalent

Meticulous preparation of these documents greatly reduces delays and audit queries.

Import License Process for Automated Lensmeter (MD15 License)

For importers intending to bring Automated Lensmeters into India, an MD15 import license is mandatory.

Key steps include:

• Preparation of comprehensive import documentation
• Submission of application in Form MD14 via the CDSCO MD Online Portal
• Addressing any clarifications or deficiencies raised by CDSCO
• Receipt of MD15 import license

Since Automated Lensmeters are Class A devices, the import license costs are lower relative to higher risk classes but still require adherence to regulatory norms.

Import License Documents Required for Automated Lensmeter

The documentation package includes:

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or equivalent from the manufacturer’s regulatory authority
• ISO 13485:2016 certification
• CE Certificate or other relevant international certifications
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution and Importer Details

Proper document alignment ensures seamless customs clearance and market entry.

Timeline and Processing Duration for CDSCO Licensing

For Automated Lensmeters, the typical timelines are:

• Test License (MD13): 1.5 to 2 months
• Product Testing: 1 to 1.5 months
• Documentation Preparation: Concurrent with testing
• Application Processing for MD5: 1 to 1.5 months
• Audit and Query Resolution: 2 to 4 weeks

Overall, expect a total duration of 3 to 4 months from start to finish for the manufacturing license.

Government Fees and Cost Structure

• MD13 Test License Application Fee: Included within overall costs
• MD5 Manufacturing License Fee: Rs 5,000 per application
• Additional Fee: Rs 500 per product

Budget for additional costs such as notified body audit fees (variable), laboratory testing charges, and consultancy support as needed.

Common Challenges and Practical Solutions

Challenge: Delays in product testing due to limited slots at government labs.

Solution: Plan testing schedules early and consider private accredited labs if permissible.

Challenge: Incomplete or inconsistent documentation leading to audit queries.

Solution: Leverage expert guidance and use comprehensive checklists such as those found in our MD5 License Guide.

Challenge: Coordination with notified bodies for timely audits.

Solution: Refer to the CDSCO notified bodies list and schedule audits well in advance.

Expert Consultation and Support

Navigating CDSCO regulations can be complex. Our 25+ years of expertise in medical device licensing have empowered over 500 companies to achieve timely approvals for devices like Automated Lensmeters. We provide tailored consultancy covering document preparation, compliance audits, training, and liaison with CDSCO authorities.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your Automated Lensmeter’s Class A status.
2. Initiate Test License Application: Prepare and submit Form MD13 on the CDSCO MD Online Portal.
3. Select Approved Testing Laboratory: Coordinate sample submission to a CDSCO-approved lab.
4. Compile Required Documents: Use our provided guides to assemble a complete dossier.
5. Engage a Notified Body: Schedule your audit early to avoid bottlenecks.
6. Submit MD5 Application: After receiving test results, file Form MD3 online.
7. Monitor and Respond: Stay proactive in addressing queries and audit feedback.

Starting early and maintaining organized documentation are key to successful licensing. Contact us today for personalized assistance to fast-track your CDSCO approval for Automated Lensmeters and enter the Indian market confidently.