CDSCO License for Mediastinoscope and accessories
Medical Device Information
Intended Use
Device intended to examine or treat tissue in the area separating the lungs for diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated.
Comprehensive Guide to CDSCO Licensing for Mediastinoscope and Accessories (Class B ENT Device)
As regulatory consultants with over 25 years of experience and having supported 500+ medical device manufacturers and importers, we understand the critical nuances involved in obtaining CDSCO licenses for specialized devices like the Mediastinoscope and its accessories. This Class B ENT device, intended for examining and treating tissues between the lungs, plays a vital role in diagnosing tumors and lesions and guiding surgical decisions. Navigating the Indian regulatory landscape efficiently requires an in-depth understanding of the CDSCO framework, document requirements, timelines, and costs.
CDSCO Regulatory Framework for Mediastinoscope and Accessories
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India under the Medical Device Rules 2017. For the Mediastinoscope and accessories, categorized under ENT devices and notified under notification number 29/Misc/03/2020-DC(196) dated 06.08.2021, the device falls under Risk Class B.
This classification mandates a careful compliance process involving product testing, documentation, and audits to ensure safety and efficacy before market entry.
Risk Classification and License Requirements
Risk Class B devices, such as the Mediastinoscope, require an MD5 manufacturing license granted by the State Licensing Authority. Importers need an MD15 import license approved by the Central Licensing Authority.
| License Type | Authority | Application Form | Process Duration | Fees (INR) |
|---|---|---|---|---|
| Manufacturing (MD5) | State Licensing Authority | MD3 | 3-4 months | Rs 5,000 + Rs 500 per product |
| Import (MD15) | Central Licensing Authority | MD14 | 5-6 months | Rs 3,000 + Rs 1,500 per product (Class B) |
Manufacturing License Process (MD5) for Mediastinoscope
Obtaining the MD5 license involves several critical steps:
- Test License (Form MD13): Initially, manufacturers must apply for a test license valid for 1.5-2 months to conduct product testing.
- Product Testing: Testing at government-approved laboratories is mandatory to validate device safety and performance. You can find the list of approved testing laboratories here.
- Document Preparation: Assemble technical and quality documents including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
- Submission of MD5 Application (Form MD3): File your manufacturing license application through the CDSCO MD Online Portal.
- Audit by Notified Body: An audit by a notified body is required to verify compliance with quality and regulatory standards. Check the list of notified bodies here.
- Query Resolution: Address any observations or queries raised during the audit or by CDSCO.
- Grant of License (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.
Manufacturing License Documents Required for Mediastinoscope
To streamline your application, ensure you have the following documents:
- Company Constitution and Incorporation Certificates
- Proof of Premises Ownership or Lease Agreement
- Qualified Technical Staff Details and Qualifications
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Guide to Device Master File)
- Plant Master File (PMF) describing manufacturing facilities and quality systems (Guide to Plant Master File)
- Essential Principles Checklist demonstrating compliance with Indian Medical Device Rules
- Risk Management File applying ISO 14971 principles (Risk Management Implementation Guide)
- Test Reports from government-approved laboratories
- Labels and Instructions for Use (IFU) conforming to CDSCO standards
- Quality Management System (QMS) documentation such as ISO 13485 certificates
Import License Process (MD15) for Mediastinoscope
Importers of the Mediastinoscope and accessories must apply for an MD15 license through the Central Licensing Authority with the following process:
- Document Preparation: Compile essential documents including the manufacturing license, Free Sale Certificate from the country of origin, CE Certificate (if applicable), and QMS evidence.
- Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
- Query Resolution: Respond promptly to any queries raised by the CDSCO during application review.
- License Grant: Upon approval, the MD15 import license is issued.
Import License Documents Required
- Valid Manufacturing License (MD5 or MD9 as applicable)
- Free Sale Certificate from the exporting country
- ISO 13485:2016 Certificate
- CE Certificate (where applicable)
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| Process Stage | Expected Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Document Preparation | 3 – 4 weeks |
| MD5 License Application | 1 – 2 months |
| Audit and Query Resolution | 3 – 4 weeks |
| Total Manufacturing License | Approximately 3-4 months |
| Import License (MD15) | Approximately 5-6 months |
Government Fees and Costs
For a Class B device like the Mediastinoscope, the fees are structured as follows:
- Manufacturing License (MD5): Rs 5,000 per application + Rs 500 per product
- Import License (MD15): Rs 3,000 per site + Rs 1,500 per product
These fees are payable online via the CDSCO portal during the application process.
Common Challenges and Solutions
- Delayed Testing Reports: Testing delays can stall the entire process. We recommend engaging accredited labs early and verifying their capacity.
- Incomplete Documentation: Missing or inconsistent documents cause repeated queries. Utilize detailed checklists aligned with CDSCO requirements.
- Audit Non-Compliance: Prepare your quality systems and site rigorously to meet notified body standards. Pre-audit mock inspections can mitigate risks.
- Query Management: Respond comprehensively and promptly to regulatory queries to avoid processing delays.
Expert Consultation and Support
With over two decades of regulatory expertise, we provide end-to-end support—from initial classification and documentation to audit preparation and license submission. Our tailored services help manufacturers and importers avoid common pitfalls, reduce timelines, and ensure compliance with evolving CDSCO standards.
Getting Started with Your CDSCO License Application
For manufacturers of the Mediastinoscope and accessories, begin by:
- Registering on the CDSCO MD Online Portal.
- Applying for the Test License (Form MD13) to initiate product testing.
- Engaging a notified body early to schedule your audit.
- Preparing detailed Device and Plant Master Files using our comprehensive guides.
- Ensuring your technical and QMS documentation complies with ISO 13485 and Indian regulatory requirements.
Starting with these actionable steps will place you on a clear path to securing your MD5 manufacturing license and subsequent MD15 import license if applicable. Our expert team is ready to assist you in every phase of the process to bring your Mediastinoscope to the Indian market efficiently and compliantly.
For more detailed insights on manufacturing licenses, explore our MD5 License Guide.
Partner with us to leverage 25+ years of regulatory experience and knowledge to achieve your CDSCO licensing goals with confidence.
