CDSCO License for Esthesiometer.

Comprehensive Guide to CDSCO Licensing for Esthesiometer (Class A Medical Device)

As a trusted regulatory consultancy with over 25 years of experience and having successfully supported 500+ manufacturers and importers, we understand the nuances of acquiring CDSCO licenses for Class A medical devices like the esthesiometer. This mechanical device is crucial in neurological assessments to measure tactile sensitivity using a fiber or rod. Navigating India’s regulatory framework effectively can speed up market entry and ensure compliance.

CDSCO Regulatory Framework for Esthesiometer

The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. The esthesiometer is classified under the neurological category and designated as a Class A device, the lowest risk class under CDSCO’s risk-based classification system. This classification mandates adherence to specific regulatory protocols aimed at ensuring safety and efficacy while facilitating a streamlined approval process.

This device falls under the notification number 29/Misc/03/2020-DC (201), dated 27.09.2021, which formally recognizes it within the regulatory system.

Risk Classification and License Requirements for Esthesiometer

The esthesiometer is a Class A device, meaning it poses the lowest risk to patients and users. For Class A devices, the manufacturing license is issued by the State Licensing Authority in the form of an MD5 license (application form MD3).

• Manufacturing License: MD5 (Class A/B devices)
• Authority: State Licensing Authority
• Total process duration: Approximately 3-4 months
• Fees: Rs 5,000 per application + Rs 500 per product

Manufacturing License Process for Esthesiometer (MD5 License)

1. Test License Application (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license that allows limited production for testing purposes. This typically takes 1.5 to 2 months.

2. Product Testing: The esthesiometer must be tested in CDSCO-approved laboratories to validate compliance with essential principles. You can find a list of approved testing laboratories here.

3. Documentation Preparation: Prepare all mandatory documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documentation.

4. Application Submission: Submit the manufacturing license application on Form MD3 through the CDSCO MD Online Portal.

5. Audit by Notified Body: A notified body conducts an audit of your manufacturing facility and QMS. Check the list of notified bodies for approved auditors.

6. Query Resolution: Address any queries raised by the regulatory department or notified body promptly.

7. Grant of License: Upon satisfactory audit and documentation review, the State Licensing Authority issues the MD5 license.

Manufacturing License Documents Required

For an esthesiometer manufacturing license application, you will need:

• Company Constitution Documents (e.g., Memorandum of Association, Partnership Deed)
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Qualification and Experience Documents of Technical Staff
• Fire NOC and Pollution Control NOC
• Device Master File (DMF) detailing design, specifications, and manufacturing process. Our detailed Device Master File guide can assist you.
• Plant Master File (PMF) describing the manufacturing environment. Refer to our Plant Master File guide for insights.
• Essential Principles Compliance Checklist
• Risk Management File focused on the esthesiometer's safety (see our Risk Management guide)
• Test Reports from CDSCO-approved labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents adhering to ISO 13485 standards

Import License Process for Esthesiometer (MD15 License)

If you are an importer of esthesiometers, the MD15 import license is required, issued by the Central Licensing Authority:

• Application Form: MD14
• Timeline: Approximately 5-6 months
• Fees: Varies by device class; for Class A, around $1000 per site +$50 per product

The process involves document preparation followed by submission on the CDSCO MD Online Portal and query resolution. Unlike manufacturing licenses, no test license is required.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate or equivalent
• ISO 13485:2016 Certification
• CE Certificate or relevant international approvals
• Device Master File
• Plant Master File
• Wholesale License
• Company Constitution Documents

Timeline and Processing Duration

For import license (MD15), expect approximately 5-6 months from application submission to license grant.

Government Fees and Costs

• MD5 Manufacturing License:

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

• MD15 Import License (Class A):

  • Per Site: $1000 (~Rs 75,000)
  • Per Product: $50 (~Rs 3,750)

Note: All fees are subject to change; always verify on the CDSCO MD Online Portal.

Common Challenges and Solutions

• Delayed Document Preparation: Many manufacturers underestimate the time required for comprehensive document compilation. Start early and utilize expert templates and guides.

• Test Lab Backlogs: CDSCO-approved labs may have waiting periods; schedule testing promptly and confirm timelines.

• Audit Non-compliance: Ensure your QMS and plant facilities meet notified body requirements ahead of audit to avoid non-conformities.

• Query Management: Respond to CDSCO queries comprehensively and within deadlines to avoid process delays.

• Understanding Technical Requirements: The esthesiometer’s functional and safety specifications must be clearly documented to satisfy regulatory scrutiny.

Expert Consultation and Support

Navigating CDSCO licensing for Class A devices like the esthesiometer requires detailed knowledge of regulatory nuances and procedural steps. Our team has helped over 500 companies achieve timely approvals by providing:

• Customized regulatory strategy
• Document preparation and review
• Coordination with notified bodies and testing labs
• Audit readiness and post-audit support

Partnering with experienced consultants can drastically reduce your time to market and mitigate compliance risks.

Getting Started with Your CDSCO License Application

1. Classify Your Device Correctly: Confirm your esthesiometer’s risk class and applicable licensing pathways.

2. Register on CDSCO MD Online Portal: Begin your journey by creating an account on the official portal.

3. Obtain Test License (MD13): Initiate the test license application to commence product testing.

4. Engage CDSCO-Approved Testing Labs: Schedule product evaluation early to avoid bottlenecks.

5. Prepare Comprehensive Documentation: Use our linked guides to develop your DMF, PMF, and QMS files.

6. Apply for Manufacturing License (MD5): Submit your license application via the portal with all required documents.

7. Prepare for Audit: Coordinate with notified bodies for facility inspections.

8. Respond to Queries: Address any department or audit-related questions promptly.

Starting your CDSCO licensing process with clear timelines and an expert roadmap can make all the difference. For tailored support and end-to-end assistance, contact us directly.

Explore more about medical device classification and licensing options on PharmaDocx.

This guide empowers manufacturers and importers of esthesiometers to effectively comply with CDSCO regulations and bring this vital neurological diagnostic tool to the Indian healthcare market with confidence.