CDSCO License for ENT chair, mechanical
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
Designed to support a patient in a seated position, mechanically control position in a way to facilitate ear, nose, throat examination, treatment, and/or minor surgery.
Comprehensive Guide to CDSCO Licensing for ENT Chair (Mechanical) - Class A Medical Device
As regulatory consultants with over 25 years of experience and having supported more than 500 companies, we understand the intricacies of obtaining CDSCO licenses for medical devices like the ENT chair (mechanical). This device, classified as Class A under the notified category ENT (Notification No. 29/Misc/03/2020-DC(196), dated 06.08.2021), requires a meticulous approach to ensure compliance and timely market entry in India.
Understanding the ENT Chair (Mechanical) and Its Regulatory Importance
The ENT chair (mechanical) is designed to securely support patients in a seated position while allowing mechanical adjustments to facilitate ear, nose, and throat examinations, treatments, and minor surgeries. Given its direct patient interface and clinical application, adherence to regulatory standards is crucial for patient safety and product efficacy.
CDSCO Regulatory Framework for ENT Chair (Mechanical)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. Since the ENT chair (mechanical) falls under Class A (low risk), it is governed primarily by state-level authorities for manufacturing licenses. However, the application process is centralized through the online portal to streamline submissions.
Risk Classification and License Requirements for ENT Chair (Mechanical)
- Device Risk Class: Class A (Low Risk)
- Category: ENT
- License Type: MD5 Manufacturing License (Application Form MD3)
- Authority: State Licensing Authority
Class A devices like the ENT chair require obtaining a test license (MD13) initially, followed by product testing, audit by a notified body, and finally, the manufacturing license.
Manufacturing License Process (MD5) for ENT Chair (Mechanical)
Apply for Test License (Form MD13): This preliminary step is mandatory to legally manufacture and test the device. The test license typically takes 1.5 to 2 months to process.
Product Testing: Conduct mandatory product testing at CDSCO accredited laboratories to verify compliance with essential principles. Visit the list of Testing Laboratories for approved labs.
Documentation Preparation: Compile comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and quality management system (QMS) documents.
Submit Application for MD5 License (Form MD3): Apply through the CDSCO MD Online Portal after ensuring all documents and test reports are in place.
Notified Body Audit: The state licensing authority will coordinate an audit by an approved notified body. Refer to the Notified Bodies List for audit partners.
Respond to Queries: Address any clarifications or additional information requests from CDSCO or the notified body promptly to avoid delays.
License Grant (Form MD5): Upon satisfactory audit and document review, the license will be granted, allowing full-scale manufacturing.
Manufacturing License Documents Required for ENT Chair (Mechanical)
- Company Constitution and Incorporation Certificate
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire Safety and Pollution Control NOCs
- Device Master File (DMF) detailing design, specifications, and performance
- Plant Master File (PMF) illustrating manufacturing environment and controls
- Essential Principles Compliance Checklist
- Risk Management File following ISO 14971 standards
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 recommended)
For detailed guidance, explore our Device Master File guide and Plant Master File guide.
Import License Process (MD15) for ENT Chair (Mechanical)
If you are an importer rather than a manufacturer, an MD15 license is required from the central licensing authority. However, since the ENT chair (mechanical) is Class A, the import license process involves:
- Preparing documents including a valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE certificate (if applicable), Device and Plant Master Files, wholesale license, and company constitution.
- Submitting the application on the CDSCO MD Online Portal.
- Responding to queries during the 5-6 months processing time.
Note: For imports, no test license is required.
Import License Documents Required
- Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Process Steps | Estimated Duration |
|---|---|---|
| Test License (MD13) | Application to grant | 1.5 to 2 months |
| Product Testing | Testing at CDSCO-approved labs | 2 to 4 weeks |
| MD5 License (Form MD3) | Submission, audit, query resolution | 1.5 to 2 months |
| Total Time | From test license to MD5 license | Approximately 3 to 4 months |
Government Fees and Costs for ENT Chair (Mechanical)
- Test License (MD13): Approximately Rs 5,000
- MD5 Manufacturing License: Rs 5,000 per application plus Rs 500 per product
- Product Testing: Variable based on number of tests required; typically Rs 50,000 - Rs 1,00,000
- Notified Body Audit: Charges vary; budget around Rs 50,000 to Rs 1,00,000
Common Challenges and Solutions
- Delays in Testing Reports: Coordinate early with CDSCO-approved labs to book slots and expedite testing.
- Incomplete Documentation: Prepare comprehensive Device and Plant Master Files upfront; use checklists to avoid omissions.
- Audit Non-Compliance: Conduct mock audits and gap assessments before the notified body visit.
- Query Resolution Delays: Assign a dedicated regulatory professional for timely and accurate responses.
Our experience highlights that proactive planning and early engagement with all stakeholders significantly reduce approval time.
Expert Consultation and Support
Navigating the CDSCO licensing landscape can be overwhelming. Our team offers tailored consultancy from documentation preparation to audit readiness. We ensure compliance with the latest regulatory updates and best practices, helping you avoid costly reworks.
Getting Started with Your CDSCO License Application for ENT Chair (Mechanical)
Review Risk Classification: Confirm Class A status via the Medical Device Classification resource.
Prepare Test License Application: Gather technical and company documents and submit Form MD13 on the CDSCO MD Online Portal.
Schedule Product Testing: Engage with CDSCO-approved testing labs early.
Develop Device and Plant Master Files: Leverage our guides for comprehensive documentation.
Plan for Notified Body Audit: Select a notified body and prepare for audit per regulatory expectations.
Submit MD5 License Application: Apply on the CDSCO portal with complete documents and test reports.
Respond Promptly to Queries: Maintain open communication with authorities.
By following these steps and leveraging expert guidance, manufacturers of ENT chair (mechanical) devices can achieve timely CDSCO licensing and confidently enter the Indian medical device market.
For more detailed assistance, explore our specialized guides on MD5 Licensing and reach out to our consultancy services.
