CDSCO License for Visualization system for arthroscopic and endoscopic procedure
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
They are used in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization and capture of still and motion pictures of surgical sites.

Comprehensive Guide to CDSCO Licensing for Visualization Systems Used in Arthroscopic and Endoscopic Procedures
Visualization systems for arthroscopic and endoscopic procedures are critical medical devices widely used to illuminate, visualize, and capture images during diagnostic and operative interventions. Given their importance in minimally invasive surgeries, these devices fall under Class A risk category in India and are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health & Family Welfare. Navigating the CDSCO licensing framework effectively ensures timely market entry and regulatory compliance.
CDSCO Regulatory Framework for Visualization Systems (Class A Medical Devices)
The regulatory oversight for visualization systems used in arthroscopy and endoscopy is governed by the Medical Device Rules (MDR) 2017, with specific notifications such as 29/Misc./03/2020-DC (193)- Part-3 dated 16.03.2022 clarifying classification and requirements. Since this device is categorized under General Hospital or Orthopaedic Instruments and classified as Class A (low risk), licensing is managed by the State Licensing Authority via the MD5 license process.
Manufacturers must comply with the essential principles of safety and performance, maintain robust Quality Management Systems (QMS), and adhere to labeling, packaging, and post-market surveillance requirements.
Risk Classification and License Requirements
- Device: Visualization system for arthroscopic and endoscopic procedures
- Risk Class: A (Low Risk)
- License Type Required: MD5 Manufacturing License (Form MD3)
- Regulatory Authority: State Licensing Authority
Class A devices require an MD5 license, which involves a test license (MD13), product testing at government-approved labs, documentation submission, audit by a notified body, and final license grant.
Manufacturing License Process for MD5 (Class A Devices)
- Apply for Test License (Form MD13): Initiate application through the CDSCO MD Online Portal to obtain a test license, which allows product testing.
- Product Testing: Submit the visualization system samples to CDSCO-approved testing laboratories. Refer to the list of testing laboratories for accredited centers.
- Documentation Preparation: Compile required documents including Device Master File (DMF), Plant Master File (PMF), QMS documents, risk management files, and more.
- Audit by Notified Body: Arrange an audit with a CDSCO-recognized notified body. Find the list of notified bodies here.
- Submit Manufacturing License Application (Form MD3): Apply for the MD5 license with the compiled documents and audit reports.
- Respond to Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
- Grant of MD5 License: Upon satisfactory compliance, the license is issued in Form MD5.
For a detailed walkthrough, you may consult our MD5 License Guide.
Manufacturing License Documents Required
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and Qualification Certificates of Technical Personnel
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) – covering technical specifications, design, manufacturing process, and intended use. Learn more from our Device Master File Guide.
- Plant Master File (PMF) – detailing manufacturing facility and quality controls. Use our Plant Master File Guide.
- Essential Principles Checklist – compliance with safety and performance requirements
- Risk Management File – demonstrating risk analysis and mitigation strategies. See our Risk Management resource.
- Test Reports from CDSCO approved labs
- Labeling and Instructions for Use (IFU)
- Quality Management System (QMS) documents (ISO 13485:2016 preferred)
Import License Process (MD15) for Visualization Systems
For importers intending to bring visualization systems into India, the MD15 import license is mandatory, granted by the Central Licensing Authority. The process is more centralized and takes approximately 5-6 months.
Key steps include:
- Document preparation (including manufacturing license from country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE certificate)
- Application submission on CDSCO MD Online Portal
- Queries resolution
- License grant in Form MD15
For import-specific guidance, refer to our Import License Guide.
Import License Documents Required
- Valid Manufacturing License issued by the regulatory authority of the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License (if applicable)
- Company Constitution
Timeline and Processing Duration
License Type | Process Steps | Approximate Duration |
---|---|---|
Test License (MD13) | Application to approval | 1.5 – 2 months |
Product Testing | Sample testing at approved labs | 1 – 1.5 months |
MD5 License Application (Form MD3) | Document submission, audit, queries resolution | 1.5 – 2 months |
Total Time for MD5 | Test license + testing + license grant | 3 – 4 months |
This timeline assumes prompt response to queries and availability of notified bodies for audits.
Government Fees and Costs
- Test License (MD13): No separate fee but part of overall process
- MD5 License Application Fee: INR 5,000 per application
- Additional Fee: INR 500 per product
Manufacturers should budget for testing fees at government-approved labs and audit fees payable to notified bodies separately.
Common Challenges and Solutions
Challenge: Delay in product testing due to limited capacity at government labs.
Solution: Plan sample submissions well in advance and consider multiple approved labs.
Challenge: Audit scheduling delays with notified bodies.
Solution: Engage early with notified bodies listed on the CDSCO portal to secure audit dates.
Challenge: Insufficient documentation leading to queries.
Solution: Utilize detailed templates and expert consultation to prepare complete and compliant documents.
Challenge: Understanding classification nuances.
Solution: Refer to the latest notifications and classification guides such as our Medical Device Classification resource.
Expert Consultation and Support
With over 25 years of experience and assistance to 500+ medical device companies, we provide end-to-end CDSCO licensing support tailored to visualization systems and other Class A devices. Our services include:
- Gap analysis of your product and documentation
- Preparing Device and Plant Master Files
- Coordinating product testing and audits
- Application drafting and submission
- Liaising with CDSCO and notified bodies
- Post-license compliance advisory
Getting Started with Your CDSCO License Application
For manufacturers of visualization systems in arthroscopic and endoscopic procedures, initiating your CDSCO MD5 license process begins with:
- Registering your company on the CDSCO MD Online Portal.
- Applying for the Test License (Form MD13) immediately to avoid delays.
- Simultaneously, begin compiling your Device Master File, Plant Master File, and Risk Management File using available guides.
- Identify and coordinate with a notified body early for the upcoming audit.
- Prepare your Quality Management System documentation aligning with ISO 13485:2016 standards.
- Plan for product testing by selecting a government-approved lab.
Taking these steps early streamlines the process and positions your visualization system for successful regulatory approval and market entry in India.
For personalized assistance in navigating the CDSCO licensing landscape for your visualization system, contact our expert regulatory team today.