CDSCO License for Amsler grid

Introduction: Understanding the Amsler Grid and Its Regulatory Significance

The Amsler Grid is a pivotal ophthalmic device designed to rapidly detect central and paracentral irregularities in the visual field. Widely used by eye care professionals, it facilitates early diagnosis of retinal conditions such as macular degeneration. Given its medical importance and direct impact on patient health, regulatory compliance in India is mandatory before manufacturing or importing this device.

As experts with over 25 years of experience guiding 500+ companies through the CDSCO licensing process, we understand the unique requirements for Class A devices like the Amsler Grid. Ensuring regulatory adherence not only validates product safety and efficacy but also builds trust with healthcare providers and end-users.

CDSCO Regulatory Framework for Amsler Grid (Class A Ophthalmic Device)

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulations in India. The Amsler Grid, notified under Fts No. 29/MiscJO3/2020-DC (187) dated 9.8.2021, is classified as a Class A device under the ophthalmology category. This classification defines the regulatory pathway, documentation, and licensing authority.

Class A devices are considered low risk and are regulated primarily by the State Licensing Authorities through the issuance of an MD5 manufacturing license. Importers and manufacturers must comply with the Medical Devices Rules, 2017, and follow the prescribed application processes on the CDSCO MD Online Portal.

Risk Classification and License Requirements for Amsler Grid

• Risk Class: A (Low risk)
• Regulatory License: MD5 Manufacturing License (Form MD3)
• Licensing Authority: State Licensing Authority
• Test License Required: Yes, Form MD13

The MD5 license process is streamlined for Class A devices but requires comprehensive documentation, testing, and audit by an approved notified body.

Manufacturing License Process for Amsler Grid (MD5 License)

1. Obtain Test License (Form MD13): The initial step involves applying for a test license, allowing product testing in government-approved labs. This takes approximately 1.5 to 2 months.
2. Product Testing: Submit the Amsler Grid samples to notified testing laboratories listed on the CDSCO Testing Laboratories page for evaluation against essential principles.
3. Document Preparation: Prepare a comprehensive dossier including Device Master File (DMF), Plant Master File (PMF), risk management file, quality management system details, and other statutory documents.
4. Application Submission: File the manufacturing license application using Form MD3 on the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit will be conducted by a notified body from the official list assessing compliance with Good Manufacturing Practices (GMP).
6. Query Resolution: Respond promptly to any queries raised by the notified body or state authorities.
7. Grant of License: Upon satisfactory review, the license is issued on Form MD5.

Manufacturing License Documents Required for Amsler Grid

For a smooth approval process, the following documents must be meticulously prepared:

• Company Constitution Documents: Incorporation certificate, partnership deed, or memorandum
• Proof of Premises Ownership: Lease agreement or property ownership documents
• Technical Staff Details: Qualification and experience certificates of key personnel
• Fire NOC & Pollution NOC: Compliance certificates from local authorities
• Device Master File (DMF): Detailed design, manufacturing process, and specifications (Guide to DMF)
• Plant Master File (PMF): Infrastructure, equipment, and quality control processes (Guide to PMF)
• Essential Principles Checklist: Compliance matrix with applicable standards
• Risk Management File: Hazard analysis and mitigation strategies (Risk Management Insights)
• Test Reports: Results from government-approved testing laboratories
• Labels and Instructions for Use (IFU): Clear, compliant product labeling and user manuals
• Quality Management System (QMS) Documents: ISO 13485 certification and SOPs

Import License Process for Amsler Grid (MD15 License)

If you intend to import the Amsler Grid into India, an import license under Form MD14 (resulting in MD15 license) from CDSCO’s Central Licensing Authority is mandatory. This process typically takes 5 to 6 months and involves:

• Document preparation including manufacturing license from country of origin, Free Sale Certificate, ISO and CE certificates
• Submission via the CDSCO MD Online Portal
• Resolution of regulatory queries
• Final grant of import license (MD15)

Note that unlike manufacturing licenses, no test license is required for imports.

Import License Documents Required for Amsler Grid

• Manufacturing License from country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate
• Device Master File and Plant Master File
• Wholesale License
• Company Constitution documents

Timeline and Processing Duration

Planning for potential delays during audits or query responses is prudent to avoid missed deadlines.

Government Fees and Costs

For the Amsler Grid as a Class A device:

• MD5 Manufacturing License Fees:

  • Application Fee: Rs. 5,000
  • Per Product Fee: Rs. 500

• Test License Fee (MD13): Included in initial application

• Import License (MD15) Fees:

  • Site Fee: $1,000
  • Per Product Fee: $50

Additional costs may include notified body audit charges, testing laboratory fees, and consultancy assistance.

Common Challenges and Solutions

• Incomplete Documentation: Always cross-check your dossier against the CDSCO checklist to avoid rejection or delays.

• Testing Delays: Schedule sample submissions early and choose notified labs with proven turnaround times.

• Audit Non-Compliance: Pre-audit internal checks and gap assessments can significantly reduce audit findings.

• Slow Query Responses: Maintain a dedicated team for rapid and accurate replies to CDSCO or notified body queries.

• Misclassification Risks: Confirm device classification early by consulting the Medical Device Classification Guide.

Expert Consultation and Support

With decades of hands-on experience, we have facilitated CDSCO licensing for over 500 companies, including numerous ophthalmic device manufacturers. Our end-to-end support includes:

• Classification and regulatory strategy
• Documentation preparation (DMF, PMF, Risk Management, QMS)
• Coordination with notified bodies and testing labs
• Application filing and query handling
• Post-approval compliance advice

Engaging expert consultants can drastically shorten approval timelines and avoid costly errors.

Getting Started with Your CDSCO License Application for Amsler Grid

1. Assess your product classification thoroughly. Confirm that the Amsler Grid is a Class A device under CDSCO rules.
2. Register your company on the CDSCO MD Online Portal.
3. Apply for the test license (Form MD13) immediately to initiate product testing.
4. Prepare all essential documents in parallel, leveraging expert templates and guidance.
5. Identify and liaise with a notified body early to schedule your GMP audit.
6. Submit your manufacturing license application (Form MD3) once testing and documentation are complete.
7. Stay responsive to queries and maintain transparent communication with regulatory authorities.

Starting early, maintaining compliance at every step, and leveraging expert support are key to a successful CDSCO licensing journey for the Amsler Grid. Contact us today to kickstart your regulatory application with confidence.