CDSCO License for Evoked response auditory stimulator

Understanding the Evoked Response Auditory Stimulator and Regulatory Importance

The Evoked Response Auditory Stimulator is a specialized medical device designed to produce sound stimuli for evoked response measurements or EEG activation, primarily used in ENT diagnostics. Given its critical role in neurological and auditory testing, regulatory compliance under the Central Drugs Standard Control Organization (CDSCO) is crucial for market access in India.

As a Class B device under the CDSCO classification system, this device falls under moderate risk, necessitating a rigorous but well-defined regulatory pathway. Our extensive experience assisting over 500 companies in navigating CDSCO licensing positions us uniquely to guide manufacturers and importers through a seamless approval process.

CDSCO Regulatory Framework for Evoked Response Auditory Stimulator (Class B ENT Device)

The CDSCO regulates medical devices under the Medical Device Rules (MDR) 2017, and the Evoked Response Auditory Stimulator is notified under Notification No. 29/Misc/03/2020-DC(196) dated 06.08.2021. Being a Class B device, the device requires an MD5 Manufacturing License if manufactured domestically or an MD15 Import License if imported.

Compliance ensures the device meets safety, quality, and efficacy standards before market entry, protecting patients and healthcare providers.

Risk Classification and License Requirements

• Risk Class: B (Moderate Risk)
• License Type: MD5 Manufacturing License (Form MD3) for Indian manufacturers
• Issuing Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months

For imports, an MD15 license issued by CDSCO Central Licensing Authority is mandatory.

For a detailed understanding of risk classification, manufacturers may refer to our Medical Device Classification guide.

Manufacturing License Process (MD5) for Evoked Response Auditory Stimulator

1. Obtain a Test License (Form MD13):

   • Apply through the CDSCO MD Online Portal.
   • Duration: 1.5 to 2 months.
   • Purpose: To allow the device to be tested in approved laboratories.

2. Product Testing:

   • Conduct tests at CDSCO-approved laboratories listed here.
   • Testing ensures compliance with Essential Principles and safety standards.

3. Documentation Preparation:

   • Compile comprehensive documents including Device Master File, Plant Master File, Risk Management File, and QMS documents.
   • Our Device Master File guide can help streamline this process.

4. Application Submission:

   • Submit the manufacturing license application (Form MD3) via the CDSCO MD Online Portal.

5. Audit by Notified Body:

   • An audit is conducted by a notified body listed here.
   • The audit assesses compliance with Good Manufacturing Practices (GMP).

6. Query Resolution:

   • Address any queries raised by CDSCO or the notified body promptly to avoid delays.

7. License Grant:

   • Upon satisfactory compliance, the MD5 license is granted on Form MD5.

Manufacturing License Documents Required for Class B Device

For the Evoked Response Auditory Stimulator, the following documents are mandatory:

• Company Constitution and Incorporation Documents
• Proof of Ownership or Lease of Manufacturing Premises
• Technical Staff Details: Qualifications and experience certificates
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Specifications, manufacturing process, and quality controls
• Plant Master File (PMF): Facility layout, equipment list, and maintenance schedules
• Essential Principles Compliance Checklist
• Risk Management File: Hazard analysis and mitigation strategies
• Test Reports: From CDSCO-approved labs
• Product Labeling Samples and Instructions for Use (IFU)
• Quality Management System (QMS) Documents: ISO 13485 certification and SOPs

Attention to detail in document preparation significantly reduces processing time and audit observations.

Import License Process (MD15) for Evoked Response Auditory Stimulator

For companies importing the Evoked Response Auditory Stimulator:

1. Document Preparation:

   • Compile documents including Manufacturing License from country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.

2. Application Submission:

   • Apply on the CDSCO MD Online Portal using Form MD14.

3. Query Resolution:

   • Respond promptly to any queries from CDSCO.

4. License Grant:

   • The MD15 Import License is granted on Form MD15.

The overall timeline for import license approval is approximately 5-6 months.

Our detailed Import License guide offers practical insights.

Timeline and Processing Duration

Planning your submission with these timelines in mind helps avoid bottlenecks.

Government Fees and Costs

• MD5 License Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Note: Additional costs include testing fees from labs and notified body audit charges, which vary based on scope.

Common Challenges and Solutions

• Delayed Test Reports: Choose CDSCO-approved testing labs with proven turnaround times.
• Incomplete Documentation: Use comprehensive checklists for Device Master File, Plant Master File, and Risk Management File.
• Audit Non-Compliance: Pre-audit internal assessments and training reduce adverse findings.
• Query Delays: Maintain proactive communication with CDSCO and promptly address queries.

Our consultancy has successfully mitigated these issues for numerous clients through tailored strategies.

Expert Consultation and Support

With over 25 years of experience and over 500 successful CDSCO license approvals, we provide end-to-end support including:

• Gap analysis of existing documentation
• Preparation of Device and Plant Master Files
• Coordination with notified bodies and testing labs
• Application drafting and submission via the CDSCO MD Online Portal
• Post-license compliance advisory

Our proven process minimizes delays and maximizes approval success.

Getting Started with Your CDSCO License Application

To initiate your MD5 license application for the Evoked Response Auditory Stimulator:

1. Assess Your Device Classification: Confirm Class B status via CDSCO guidelines.
2. Prepare Test License Application (Form MD13): Gather preliminary technical documents.
3. Select an Approved Testing Laboratory: Coordinate sample submission and testing.
4. Develop Complete Documentation: Focus on Device Master File and Risk Management File.
5. Engage a Notified Body Early: Schedule pre-audit consultations.
6. Submit Application Through the CDSCO MD Online Portal.

Taking these proactive steps will streamline your path to market entry. Contact us today to leverage our expertise and ensure a hassle-free CDSCO licensing experience for your Evoked Response Auditory Stimulator.