CDSCO License for Audiometer testing system

Comprehensive Guide to CDSCO Licensing for Audiometer Testing System (Class A Device)

As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies, we understand the nuances involved in obtaining CDSCO licenses for medical devices like the Audiometer Testing System. This device, classified as Class A, is an electronic reference assembly used specifically for calibrating audiometers in the ENT category. With the official notification number 29/Misc/03/2020-DC(196) dated 06.08.2021, compliance with CDSCO regulations is mandatory to legally manufacture or import this device in India.

CDSCO Regulatory Framework for Audiometer Testing Systems

The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Being a Class A device, the Audiometer Testing System falls under the lowest risk category, resulting in a relatively streamlined licensing process. The regulatory framework mandates adherence to quality, safety, and efficacy standards as per the Medical Device Rules, 2017.

Risk Classification and License Requirements

Class A devices like the Audiometer Testing System require an MD5 Manufacturing License, issued by the State Licensing Authority. For importers, an MD15 Import License is necessary, granted by the Central Licensing Authority. The classification is crucial as it dictates the application forms, fees, timelines, and audit processes involved. To understand the classification better, you can review the Medical Device Classification guidelines.

Manufacturing License Process (MD5) for Audiometer Testing Systems

1. Test License Acquisition (Form MD13): Before applying for the manufacturing license, manufacturers must obtain a test license. This phase typically takes 1.5 to 2 months.

2. Product Testing: The device must be tested in government-approved laboratories to verify compliance. Refer to the Testing Laboratories for accredited options.

3. Documentation Preparation: Compile all essential documents, including technical and quality management files.

4. Application Submission (Form MD3): Apply for the MD5 license through the CDSCO MD Online Portal.

5. Audit by Notified Body: A compulsory audit by an authorized notified body is conducted. Check the list of notified bodies to select the auditor.

6. Query Resolution: Address any queries raised by the department or auditor promptly.

7. License Grant (Form MD5): Upon successful review and audit, the license is granted.

Manufacturing License Documents Required

• Company Constitution (e.g., MOA, AOA)
• Proof of Ownership or Lease of Manufacturing Premises
• Details and Qualifications of Technical Staff
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF) – See our Device Master File guide
• Plant Master File (PMF) – Refer to our Plant Master File guide
• Essential Principles Checklist
• Risk Management File – Learn more about Risk Management
• Test Reports from Government-Approved Labs
• Product Labels and Instructions for Use (IFU)
• Quality Management System (QMS) Documents (ISO 13485 compliant)

Import License Process (MD15) for Audiometer Testing Systems

Although the focus here is on manufacturing, importers must obtain an MD15 import license through the Central Licensing Authority. The process generally takes 5 to 6 months and requires comprehensive documentation such as Manufacturing License, Free Sale Certificate from the country of origin, ISO 13485 certification, CE Certificate, and other supporting files.

For detailed import procedures, check our Import License guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License (if applicable)
• Company Constitution

Timeline and Processing Duration

• Test License (MD13): 1.5 to 2 months
• Product Testing: Concurrent with test license or immediately after
• MD5 Manufacturing License: Approximately 3 to 4 months (including audit and query resolution)

Total Estimated Time: 3.5 to 4.5 months from initial test license application to receipt of MD5 license.

Government Fees and Costs

• Application Fee: Rs 5,000 per application
• Per Product Fee: Rs 500 per product

These fees are payable online via the CDSCO MD Online Portal. Budgeting for additional costs such as notified body audit fees, testing charges, and consultancy support is advisable.

Common Challenges and Solutions

• Incomplete Documentation: Ensure meticulous preparation of Device Master File and Plant Master File to avoid delays.
• Delayed Testing Results: Engage with government-approved labs early to schedule testing.
• Audit Non-Compliance: Pre-audit internal assessments can reduce non-conformities.
• Query Resolution Delays: Assign a dedicated regulatory contact to respond promptly.

Expert Consultation and Support

Given the detailed nature of CDSCO licensing, partnering with experts who understand the regulatory landscape can streamline the process. Our deep expertise ensures compliance with minimal rework, timely submissions, and effective communication with CDSCO authorities.

Getting Started with Your CDSCO License Application

1. Evaluate Device Classification: Confirm the Audiometer Testing System is Class A under CDSCO rules.
2. Register on the CDSCO MD Online Portal: This is mandatory for all submissions.
3. Prepare Test License Application (Form MD13): Assemble required documents and apply.
4. Schedule Product Testing: Coordinate with notified testing labs.
5. Develop Comprehensive Documentation: Focus on DMF, PMF, Risk Management, and QMS.
6. Select Notified Body for Audit: Choose from the list of notified bodies.
7. Submit Manufacturing License Application (Form MD3) post testing and audit preparation.

By following these steps, manufacturers can confidently navigate the licensing process for the Audiometer Testing System. For tailored assistance, feel free to reach out to our regulatory consulting team who have successfully guided numerous clients through CDSCO licensing complexities.