CDSCO License for Otoacoustic emission system, line-powered
Medical Device Information
Intended Use
An assembly of mains electricity (AC-powered) devices designed to record and analyse the faint sounds hair cells in the inner ear emit [otoacoustic emission (OAE)] in response to a stimulus (e.g., click, tone burst, pure- tone signals) to test for a deficiency of function in the ear during diagnostic evaluation and/or neonatal screening. It typically consists of a programmable unit, an OAE probe, and eartips. The stimulus signal is emitted via the probe inserted into the ear canal and the response is recorded via a microphone in the probe; OAEs are absent/reduced in patients with hearing loss. The system may be combined with other audiological devices (e.g., tympanometer, ABR device).
Comprehensive Guide to CDSCO Licensing for Otoacoustic Emission System (Line-Powered) – Class B Medical Device
As a trusted regulatory consultancy with over 25 years of experience and having supported 500+ companies in India’s medical device regulatory landscape, we understand the critical importance of a smooth and compliant CDSCO licensing process. This guide focuses on the Otoacoustic Emission (OAE) System, line-powered, a Class B medical device widely used in pediatrics and neonatology for early hearing screening and diagnostic evaluation.
Introduction: About Otoacoustic Emission Systems and Regulatory Importance
An OAE system is an AC-powered assembly designed to record and analyze faint sounds emitted by hair cells in the inner ear in response to auditory stimuli. These systems are essential in detecting hearing deficiencies, particularly in newborns and pediatric patients. Given their diagnostic significance, regulatory oversight by CDSCO (Central Drugs Standard Control Organization) ensures safety, efficacy, and quality before market entry.
CDSCO Regulatory Framework for Otoacoustic Emission Systems
Under India's medical device regulations, the OAE system is classified as a Class B (low-moderate risk) medical device. As such, the licensing authority lies with the respective State Licensing Authority, and the manufacturing license required is the MD5 license. This regulatory route includes stringent product testing, documentation, and audits to maintain compliance with Indian and international standards.
Risk Classification and License Requirements for Class B Devices
- Risk Class: B (Low Moderate Risk)
- License Type: MD5 Manufacturing License
- Application Form: MD3
- Authority: State Licensing Authority
- Typical Timeline: 3-4 months (end-to-end)
- Fees: Rs 5,000 per application + Rs 500 per product
You can verify device classification and risk management approaches through our detailed Medical Device Classification and Risk Management guides.
Manufacturing License Process (MD5) for OAE Systems
The MD5 license process involves several key stages:
Test License Application (Form MD13): Initiate with the test license to allow product testing. This takes approximately 1.5 to 2 months.
Product Testing: Conduct mandatory testing at government-approved laboratories. For your OAE system, critical parameters include electrical safety, performance accuracy, and biocompatibility of ear tips. Refer to the Testing Laboratories list.
Document Preparation: Compile Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and QMS documentation.
Application Submission (Form MD3): Submit the complete application for MD5 license through the CDSCO MD Online Portal.
Audit by Notified Body: An on-site audit by a notified body listed on the Notified Bodies List for MD5 Audit will assess manufacturing facilities and compliance.
Query Resolution: Address any departmental or audit queries promptly to avoid delays.
License Grant: Upon satisfactory review, the State Licensing Authority issues the MD5 license (Form MD5).
Manufacturing License Documents Required for OAE Systems
Accurate and comprehensive documentation is paramount. Prepare the following:
- Company Constitution: Memorandum and Articles of Association
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Details: Qualifications and experience
- Fire NOC and Pollution Control NOC
- Device Master File: Detailed device description, design, and manufacturing process (Device Master File Guide)
- Plant Master File: Details about manufacturing facilities (Plant Master File Guide)
- Essential Principles Checklist: Conformity with Indian standards
- Risk Management File: Hazard analysis and risk mitigation
- Test Reports: From approved labs covering electrical safety and performance
- Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals
- Quality Management System (QMS) Documents: ISO 13485:2016 certifications and internal SOPs
Import License Process (MD15) for OAE Systems
If you are an importer intending to bring OAE systems into India, the process is handled centrally by CDSCO:
- License Type: MD15 Import License
- Application Form: MD14
- Authority: Central Licensing Authority
- Timeline: 5-6 months
- Fees: Class B devices attract Rs 2000 per site and Rs 1000 per product
The import license requires additional documentation such as manufacturing license from the country of origin, Free Sale Certificate, CE Certificate, and wholesale license in India.
For more details, consult 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 or equivalent
- Device Master File and Plant Master File
- Wholesale Drug License in India
- Company Constitution
Timeline and Processing Duration
| Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | 1 month |
| Application Processing | 1 to 1.5 months |
| Audit and Query Resolution | 2 to 3 weeks |
| Total Time (MD5) | 3 to 4 months |
Government Fees and Costs
- MD5 Application Fee: Rs 5,000
- Per Product Fee: Rs 500
- Test License Fee (MD13): Nominal, varies by state
- Testing Charges: Approx Rs 50,000 to Rs 1,00,000 depending on test scope
- Audit Fees: Paid to notified body; ranges from Rs 30,000 to Rs 60,000
Common Challenges and Solutions
Delayed Test Reports: Choose government-approved labs with proven turnaround times. Early booking is recommended.
Incomplete Documentation: Utilize our checklists to ensure all files, especially Device and Plant Master Files, are comprehensive.
Audit Non-Compliance: Prepare thoroughly by conducting internal mock audits and training staff.
Query Resolution Delays: Assign a dedicated regulatory liaison to respond promptly to CDSCO queries.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for devices like OAE systems with multiple components and strict quality requirements. Our consultancy offers:
- Customized documentation support
- Liaison with notified bodies and CDSCO officials
- Comprehensive training on regulatory compliance
- Audit preparation and mock inspections
Reach out to leverage our 25+ years of expertise and expedite your product’s market entry.
Getting Started with Your CDSCO License Application
Assess Device Classification: Confirm your OAE system’s classification as Class B.
Plan Testing and Documentation: Initiate test license application and gather all technical and QMS documents.
Apply for Test License (MD13): Submit through the CDSCO MD Online Portal.
Schedule Product Testing: Coordinate with approved labs early to avoid bottlenecks.
Prepare for Audit: Engage a notified body from the official Notified Bodies List and ensure facility readiness.
Submit MD5 Application: Complete the application on the CDSCO portal and monitor progress diligently.
Respond to Queries Promptly: Maintain open communication with CDSCO and auditors.
By following these actionable steps and working with experienced consultants, you can successfully obtain the MD5 license for your Otoacoustic Emission System, ensuring compliance and timely access to the Indian market.
For an in-depth walkthrough of the licensing process, visit our detailed MD5 License Guide.
We invite manufacturers and importers to contact us today to begin your CDSCO licensing journey with confidence and clarity.
