CDSCO License for Tympanic membrane contact hearing aid
Medical Device Information
Intended Use
A tympanic membrane contact hearing aid is a prescription device that compensates for impaired hearing by vibrating the tympanic membrane through a transducer that is in direct contact with the tympanic membrane.
Comprehensive Guide to CDSCO Licensing for Tympanic Membrane Contact Hearing Aids (Class B)
Manufacturing or importing a Tympanic Membrane Contact Hearing Aid, a Class B medical device under the ENT category, requires strict adherence to the Central Drugs Standard Control Organization (CDSCO) regulations in India. This device, designed to compensate for impaired hearing by vibrating the tympanic membrane directly, falls under the moderate risk category, necessitating a robust licensing process to ensure safety and efficacy. With over 25 years of experience and having assisted more than 500 companies, we provide you with a detailed roadmap to successfully obtain the necessary CDSCO license.
CDSCO Regulatory Framework for Tympanic Membrane Contact Hearing Aids
The CDSCO regulates all medical devices in India under the Medical Device Rules (MDR) 2017, amended periodically. Hearing aids like the tympanic membrane contact type are classified as Class B devices, indicating moderate risk. The regulatory framework mandates obtaining a manufacturing license (MD5) from the State Licensing Authority before you can legally manufacture or market this device.
Risk Classification and License Requirements
According to the official notification 29/Misc/03/2020-DC(196), dated 06.08.2021, this device is categorized as Class B. Class B devices require:
- MD5 Manufacturing License (Application Form MD3)
- Test license on Form MD13 before the main application
- Product testing from CDSCO-approved laboratories
- Audit by a notified body
You can find a detailed explanation of classification here.
Manufacturing License Process for Tympanic Membrane Contact Hearing Aids (MD5 License)
The MD5 license is granted by the State Licensing Authority and involves the following steps:
- Test License Application (Form MD13): Initially, apply for a test license which takes approximately 1.5 to 2 months to grant.
- Product Testing: Submit your device samples to government-approved testing laboratories. A list is available on the CDSCO Testing Laboratories portal.
- Document Preparation: Compile all necessary technical and quality documents.
- License Application (Form MD3): Submit your manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: Undergo an audit by a notified body to verify compliance. You can check the list of notified bodies here.
- Query Resolution: Address any queries raised by the licensing authority or notified body.
- Grant of License (Form MD5): Upon successful review and audit, the license is granted.
Manufacturing License Documents Required
For a Class B device like the tympanic membrane contact hearing aid, the typical documentation includes:
- Company Constitution (Incorporation Certificate)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical personnel
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed design and manufacturing process documentation (Guide here)
- Plant Master File (PMF): Details of the manufacturing facility (Guide here)
- Essential Principles Checklist ensuring compliance with safety and performance standards
- Risk Management File documenting hazard identification and mitigation (Learn more)
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 certification
Import License Process for Tympanic Membrane Contact Hearing Aids (MD15 License)
If you are an importer of this device, an MD15 Import License from the Central Licensing Authority is mandatory. The process includes:
- Document preparation (including Manufacturing License from country of origin, Free Sale Certificate, CE Certificate, ISO 13485:2016)
- Submission of application on the CDSCO MD Online Portal
- Resolution of any queries
- Issuance of Import License (Form MD15)
The process typically takes 5 to 6 months.
Import License Documents Required
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution
Timeline and Processing Duration
| License Type | Authority | Timeline |
|---|---|---|
| Test License (MD13) | State Licensing Authority | 1.5 to 2 months |
| MD5 Manufacturing License | State Licensing Authority | 3 to 4 months (including audit and query resolution) |
| MD15 Import License | Central Licensing Authority | 5 to 6 months |
Overall, for manufacturing, expect around 4 months from test license initiation to MD5 grant.
Government Fees and Costs
For Class B devices like the tympanic membrane contact hearing aid:
MD5 License:
- Application Fee: ₹5,000 per application
- Product Fee: ₹500 per product
MD15 Import License:
- Site Fee: $2,000 (approx ₹1.5 lakh)
- Product Fee: $1,000 (approx ₹75,000) per product
These fees are payable online via the CDSCO portal.
Common Challenges and Solutions
Challenge: Delays in audit scheduling or query resolution.
Solution: Engage early with a notified body and prepare comprehensive, compliant documentation to minimize back-and-forth.
Challenge: Difficulty in obtaining accurate test reports.
Solution: Use CDSCO-approved testing labs only. Refer to the approved labs list.
Challenge: Incomplete or insufficient Device Master and Plant Master Files.
Solution: Follow detailed guidelines and consider expert consultation to prepare robust DMFs and PMFs.
Expert Consultation and Support
Navigating the CDSCO licensing process for devices like tympanic membrane contact hearing aids can seem daunting. With our extensive experience assisting over 500 companies, we offer:
- End-to-end application preparation and submission
- Technical document drafting including DMF, PMF, risk management
- Coordination with notified bodies and testing laboratories
- Query resolution and audit support
Our proven approach ensures timely approvals and compliance with all regulatory mandates.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm your device is Class B as per the official notification.
- Prepare Your Test License Application: Gather documents and apply for the MD13 test license via the CDSCO MD Online Portal.
- Coordinate Testing: Send your device samples to an approved laboratory.
- Compile Documentation: Prepare your DMF, PMF, QMS, and other required files.
- Engage a Notified Body: Schedule your audit early to avoid delays.
- Submit MD5 Application: Apply on the CDSCO portal using Form MD3.
- Address Queries Promptly: Respond to any department or notified body queries efficiently.
Taking these concrete steps will put you on the path to successful licensing for your tympanic membrane contact hearing aid in India. For personalized assistance, feel free to reach out to our regulatory experts who specialize in CDSCO medical device licensing.
For more detailed guidance, explore our comprehensive MD5 License Guide or contact us directly to streamline your regulatory journey.
