CDSCO License for Acoustic chamber for audiometric testing
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
An acoustic chamber for audiometric testing is a room that is intended for use in conducting diagnostic hearing evaluations and that eliminates sound reflections and provides isolation from outside sounds.
Comprehensive Guide to CDSCO Licensing for Acoustic Chambers Used in Audiometric Testing
Acoustic chambers designed for audiometric testing play a pivotal role in ENT diagnostics by providing a controlled environment free from external noise interference. Given their critical use in hearing evaluations, regulatory compliance under the Central Drugs Standard Control Organisation (CDSCO) is mandatory before manufacturing or importing these devices in India. With over 25 years of regulatory consulting experience and having supported 500+ companies, we provide a detailed roadmap to help you secure a CDSCO license efficiently for your Class A acoustic chamber.
CDSCO Regulatory Framework for Acoustic Chambers
The acoustic chamber for audiometric testing falls under the ENT category and is classified as a Class A medical device by CDSCO. This classification reflects its low risk profile but does not exempt it from stringent regulatory requirements. The device is notified under the notification number 29/Misc/03/2020-DC(196) dated 06.08.2021, which clarifies its regulatory status. Compliance ensures patient safety, product quality, and market access.
Risk Classification and License Requirements for Class A Devices
Class A devices, considered low risk, require a manufacturing license known as the MD5 license, granted by the State Licensing Authority. The entire licensing process including testing and audit typically spans 3-4 months. The MD5 license ensures your facility and product meet quality and safety standards.
For detailed classification insights, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Acoustic Chambers
Obtaining an MD5 license for your acoustic chamber involves several critical steps:
Test License (Form MD13): Begin by applying for a test license, which enables you to conduct product testing. This phase takes approximately 1.5-2 months.
Product Testing: Conduct tests at CDSCO-approved laboratories. For acoustic chambers, key parameters include sound isolation efficacy and compliance with audiometric testing standards. You can find the list of Testing Laboratories here.
Document Preparation: Compile necessary documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and other quality system records.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body will audit your manufacturing site for compliance. Refer to the Notified Bodies List for authorized auditors.
Queries and Resolution: Address any queries raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory review and audit, the license is granted.
For a step-by-step walkthrough, our MD5 License Guide offers practical tips tailored to Class A devices.
Manufacturing License Documents Required for Acoustic Chambers
Accurate and complete documentation is critical to avoid delays:
- Company Constitution: Incorporation certificates, Articles of Association.
- Proof of Premises Ownership or Lease Agreement.
- Technical Staff Details: Qualifications and experience certificates.
- Fire NOC & Pollution Control NOC: Mandatory safety clearances.
- Device Master File (DMF): Detailed design, manufacturing process, and specifications. Our Device Master File guide can assist.
- Plant Master File (PMF): Information on manufacturing facilities and quality controls. Learn more in our Plant Master File guide.
- Essential Principles Checklist: Confirming compliance with Indian regulations.
- Risk Management File: Risk assessment and mitigation strategies as per ISO 14971. Refer to our Risk Management guide for best practices.
- Test Reports: From government-approved labs validating acoustic performance.
- Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements.
- Quality Management System (QMS) Documents: Evidence of ISO 13485 certification and internal SOPs.
Import License Process (MD15) for Acoustic Chambers
If you plan to import acoustic chambers into India, an MD15 import license from the Central Licensing Authority is mandatory. The process is slightly more extensive with a typical timeline of 5-6 months.
Key steps include:
- Document preparation (including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certificate, CE certificate if applicable).
- Submission of application via the CDSCO MD Online Portal.
- Resolution of any departmental queries.
- Final grant of import license (Form MD15).
For detailed guidance, explore our Import License Guide.
Import License Documents Required
- Valid manufacturing license from the country of origin.
- Free Sale Certificate.
- ISO 13485:2016 certification.
- CE Certificate (if applicable).
- Device Master File.
- Plant Master File.
- Wholesale license.
- Company Constitution.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 4 weeks |
| License Application Processing | 1 - 1.5 months |
| Audit and Queries Resolution | 3 - 4 weeks |
| Total Estimated Time | 3 - 4 months |
Government Fees and Costs
- Application Fee: ₹5,000 per MD5 license application.
- Product Fee: ₹500 per product.
- Testing and Audit Costs: Variable depending on notified body and testing lab fees.
Budgeting for testing and audit is critical. Working with experienced consultants can help optimize these costs.
Common Challenges and Solutions
- Delayed Testing Results: Select accredited labs early and confirm testing timelines upfront.
- Incomplete Documentation: Use comprehensive checklists and expert review to ensure all documents are in order.
- Audit Non-conformities: Conduct internal pre-audit assessments and train your staff on compliance requirements.
- Query Backlogs: Respond promptly and thoroughly to CDSCO queries to avoid process stagnation.
Proactive planning and expert guidance mitigate these common hurdles.
Expert Consultation and Support
Navigating CDSCO licensing for acoustic chambers can be complex. Our 25+ years of experience mean we understand the nuances of compliance, document preparation, and audit processes. We have successfully assisted over 500 manufacturers and importers in securing timely approvals. Our services include:
- Gap analysis and readiness assessments.
- Preparation of Device and Plant Master Files.
- Coordination with notified bodies and testing labs.
- Application submission and follow-up.
- Training on regulatory updates.
Partnering with experts accelerates your market entry and ensures sustained compliance.
Getting Started with Your CDSCO License Application
- Identify Your Device Classification: Confirm your device as Class A under CDSCO's framework.
- Gather Core Documents: Start compiling company, technical, and facility documentation.
- Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to initiate product testing.
- Select Accredited Testing Laboratory: Engage early with a CDSCO-approved lab for timely testing.
- Prepare Master Files and Risk Documentation: Use our comprehensive guides to develop robust DMF and PMF.
- Plan for Audit: Schedule and prepare your facility for notified body inspection.
- Submit Manufacturing License Application (MD3): Once testing and documentation are complete, apply through the portal.
Starting early and adhering to timelines is crucial. For personalized assistance and to ensure a smooth licensing journey for your acoustic chamber, contact us today and leverage our proven expertise.
