CDSCO License for Adaptometer

Introduction: Understanding the Adaptometer and Its Regulatory Significance

The Adaptometer is a specialized ophthalmic device designed to measure the time required for retinal adaptation and determine the minimum light threshold. Given its critical role in eye care diagnostics, the device holds a Class B risk classification under the Indian medical device regulatory framework. Navigating the Central Drugs Standard Control Organisation (CDSCO) licensing process is essential for manufacturers and importers who wish to legally market the Adaptometer in India. With over 25 years of experience assisting 500+ companies to secure their CDSCO licenses, we provide a detailed roadmap tailored specifically for this device.

CDSCO Regulatory Framework for Ophthalmic Devices Like Adaptometer

The CDSCO regulates medical devices under the Drugs and Cosmetics Act, 1940, and its subsequent amendments. Since the Adaptometer falls under ophthalmology and is classified as Class B, it is subject to a moderate risk-based control system. This classification requires obtaining the MD5 manufacturing license from the State Licensing Authority for domestic manufacturers. Importers need to secure an MD15 import license from the Central Licensing Authority.

India's regulatory protocol ensures device safety, efficacy, and quality assurance through structured documentation, testing, and audit processes. Familiarity with these guidelines minimizes delays and compliance risks.

Risk Classification and License Requirements for the Adaptometer

The Adaptometer is categorized as a Class B medical device following the CDSCO risk classification guidelines outlined in Notification Fts No. 29/MiscJO3/2020-DC (187), dated 9.8.2021. This classification dictates the licensing path:

• Class B (Low-Medium Risk): Requires MD5 manufacturing license (Application Form MD3) from the State Licensing Authority.
• Test License (Form MD13): Mandatory initial step to facilitate product testing.

For importers, the MD15 license issued by CDSCO's Central Licensing Authority is mandatory.

For more details on device classification, you can refer to the Medical Device Classification guide.

Manufacturing License Process for Adaptometer (MD5 License)

Obtaining the MD5 license for your Adaptometer involves a multi-step process:

1. Apply for Test License (MD13): This initial license allows you to submit the device for mandatory testing at CDSCO-approved labs. Processing time is approximately 1.5 to 2 months.
2. Device Testing: Product samples must be tested for safety and performance by notified testing laboratories. Visit the CDSCO Testing Laboratories list to select an approved lab.
3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.
4. Application Submission: Submit the MD5 license application via the CDSCO MD Online Portal using Form MD3.
5. Audit by Notified Body: The State Licensing Authority will appoint a notified body to conduct a facility audit. Check the List of Notified Bodies for audit options.
6. Query Resolution: Address any queries raised by the notified body or CDSCO inspectors promptly.
7. Grant of Manufacturing License (Form MD5): Upon satisfactory compliance, the MD5 license is granted.

The entire process typically spans 3 to 4 months.

Manufacturing License Documents Required for Adaptometer

To streamline your application, ensure you prepare the following documents:

• Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
• Proof of Ownership or Tenancy of Manufacturing Premises
• Technical Staff Details (Qualifications and experience certificates)
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Detailed device description, design, manufacturing process. Our Device Master File guide provides step-by-step instructions.
• Plant Master File (PMF): Manufacturing infrastructure and systems documentation. Refer to our Plant Master File guide for comprehensive details.
• Essential Principles Checklist: Compliance matrix with Indian medical device rules.
• Risk Management File: Hazard analysis and mitigation strategies. Implement best practices from our Risk Management resource.
• Test Reports from CDSCO-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 certification, SOPs, CAPA, etc.)

Import License Process for Adaptometer (MD15 License)

Importers aiming to bring the Adaptometer to India must acquire the MD15 import license:

1. Prepare Documentation: Includes manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and Wholesale license.
2. Submit Application: Apply on the CDSCO MD Online Portal using Form MD14.
3. Review and Queries: CDSCO will review documentation and may raise queries.
4. License Grant: Upon satisfactory review, the MD15 license is issued.

The process generally takes 5 to 6 months.

Import License Documents Required for Adaptometer

• Valid Manufacturing License from country of origin
• Free Sale Certificate (FSC) from the exporting country
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License for import and distribution
• Company Constitution and registration documents

For a detailed walkthrough, see our Import License guide.

Timeline and Processing Duration

Planning ahead and maintaining clear communication with regulatory bodies can significantly reduce unexpected delays.

Government Fees and Costs for Adaptometer Licensing

• MD5 License: Rs 5,000 per application + Rs 500 per product
• MD13 Test License: Included in MD5 process fees
• MD15 Import License: Fees vary by class; for Class B devices like Adaptometer, expect approximately $2,000 per site and$1,000 per product

Budgeting accurately for these fees along with internal costs for document preparation, testing, and audits is crucial.

Common Challenges and Practical Solutions

• Delayed Testing Results: Opt for CDSCO-approved labs with proven turnaround times. Early sample submission helps.
• Incomplete Documentation: Utilize detailed checklists and expert consultation to avoid missing critical files.
• Audit Non-compliance: Conduct internal mock audits and corrective actions before the official audit.
• Query Resolution Delays: Prepare a dedicated regulatory team to respond promptly to CDSCO or notified body queries.

Our extensive experience shows that proactive preparation is the key to overcoming these hurdles efficiently.

Expert Consultation and Support

With over 25 years in Indian medical device regulatory consulting, we have supported over 500 companies in successfully obtaining CDSCO licenses. Our expertise includes:

• Gap analysis of your current compliance status
• End-to-end dossier preparation and submission
• Coordination with notified bodies and CDSCO inspectors
• Training your team on regulatory updates and audit readiness

Partnering with seasoned consultants significantly enhances your chances of timely license approval.

Getting Started with Your CDSCO License Application for Adaptometer

1. Assess Your Device Classification: Confirm Adaptometer is Class B per the latest CDSCO notification.
2. Gather Required Documentation: Begin compiling your Device Master File, Plant Master File, and supporting documents.
3. Apply for Test License (MD13): Submit this first application via the CDSCO MD Online Portal.
4. Schedule Product Testing: Coordinate with CDSCO-approved laboratories early.
5. Prepare for Audit: Engage a notified body from the official list of notified bodies and conduct internal audits.
6. Submit Manufacturing License Application (MD5): After successful testing and audit preparation, apply through the portal.

Starting early and maintaining organized documentation will position your Adaptometer for a smooth regulatory journey into the Indian market. Contact us to leverage our expertise and ensure your CDSCO licensing process is seamless and compliant.