CDSCO License for Endoscopic electrosurgical electrode/submucosal lift needle
Medical Device Information
Intended Use
A sterile, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) an electrosurgical current in a monopolar configuration (i.e., with a return electrode) to tissues for cutting/coagulation.
Comprehensive Guide to CDSCO Licensing for Endoscopic Electrosurgical Electrode/Submucosal Lift Needle (Class B)
As seasoned regulatory consultants with over 25 years of experience and a track record of assisting 500+ companies to successfully secure CDSCO licenses, we understand the nuanced requirements for medical devices like the endoscopic electrosurgical electrode/submucosal lift needle. This device, classified as Class B under the Indian regulatory framework, is a sterile, invasive endoscopic instrument designed for gastroenterology applications. It delivers both a submucosal lifting solution and electrosurgical current (monopolar configuration) for precise cutting and coagulation.
Navigating the CDSCO licensing pathway can be complex, especially for devices with dual functionalities and invasive nature. This guide provides detailed, actionable insights on the regulatory framework, licensing process, documentation, timelines, costs, and common challenges specifically tailored for this device type.
CDSCO Regulatory Framework for Endoscopic Electrosurgical Electrodes
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017, which align device classification and controls with risk profiles. The endoscopic electrosurgical electrode falls under Class B, indicating a low to moderate risk invasive device.
Regulatory compliance includes product registration, manufacturing/import licensing, quality management adherence (ISO 13485:2016), and post-market vigilance. The device is notified under the gazette notification [29/Misc./03/2020-DC (182)] dated 27.09.2021, emphasizing its regulated status.
Manufacturers and importers must comply with these mandates to legally market their devices in India.
Risk Classification and License Requirements
Risk Class: B
According to CDSCO’s risk classification:
- Class A/B devices require an MD5 license (manufacturing) issued by the State Licensing Authority.
- Importers must obtain an MD15 license from the Central Licensing Authority.
This device’s classification as Class B means the MD5 license application process involves comprehensive testing, documentation, and audit by a notified body.
For detailed classification criteria, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Class B Devices
The MD5 license process involves several sequential steps:
Test License Application (Form MD13): Before full manufacturing license application, manufacturers must apply for a test license to produce samples for testing. This takes approximately 1.5 to 2 months.
Product Testing: Samples must be tested at CDSCO-approved government laboratories. Testing validates compliance with essential principles and safety standards.
Document Preparation: Comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents are prepared.
Application for Manufacturing License (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body from the official list of notified bodies conducts a mandatory audit of the manufacturing facility and QMS.
Resolution of Queries: Address any observations or queries raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon successful completion, the manufacturing license is issued.
For in-depth guidance, consult our MD5 License Guide.
Manufacturing License Documents Required
For the endoscopic electrosurgical electrode, the following documents are critical:
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Detailed device specifications, manufacturing process, and validation (Device Master File Guide)
- Plant Master File (PMF): Facility layout, equipment details, and quality control procedures (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian regulations
- Risk Management File documenting hazard analysis and mitigation strategies (Risk Management)
- Test Reports from CDSCO-approved laboratories (Testing Laboratories)
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 compliance)
Ensuring these documents are meticulously prepared and aligned with regulatory expectations significantly reduces processing delays.
Import License Process (MD15) for Endoscopic Electrosurgical Electrodes
Importers intending to bring Class B devices into India must obtain an MD15 license from CDSCO Central Licensing Authority. The process is as follows:
Document Compilation: Gather manufacturing license, free sale certificate, ISO 13485:2016 certification, CE certificate (if applicable), Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: Apply via the CDSCO MD Online Portal using Form MD14.
Query Resolution: Address any requests for additional information from CDSCO.
License Grant: CDSCO issues the import license (Form MD15) upon satisfactory review.
The import license typically takes 5 to 6 months to process.
For a comprehensive walkthrough, see our Import License Guide.
Import License Documents Required
- Valid Manufacturing License (MD5 for Class B devices)
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent regulatory approval
- Device Master File and Plant Master File
- Wholesale license for distribution
- Company Constitution and ownership documents
Preparing these documents in alignment with CDSCO expectations ensures smoother license approval.
Timeline and Processing Duration
| License Type | Process Steps | Timeline |
|---|---|---|
| MD5 Manufacturing | Test License → Testing → Audit | 3-4 months total |
| MD15 Import | Documentation → CDSCO Review | 5-6 months |
Key timeframes:
- Test License (MD13): 1.5–2 months
- Product Testing: 3–4 weeks depending on lab backlog
- Audit and Query Resolution: 4–6 weeks
Proactive document preparation and prompt query responses can significantly reduce these timelines.
Government Fees and Costs
MD5 License (Class B):
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
Additional costs to budget for:
- Testing fees at government-approved labs
- Notified body audit charges (varies, typically Rs. 50,000+ depending on scope)
- Consultancy or legal fees if using expert support
MD15 Import License:
- Site Fee (Class B): Approx. $2,000 USD
- Product Fee: Approx. $1,000 USD per product
Fees are payable online via the CDSCO portal and are subject to periodic revisions.
Common Challenges and Solutions
Incomplete Documentation: Many applicants face delays due to missing or inconsistent documents. Solution: Use our detailed checklists and templates for DMF, PMF, and risk files.
Testing Delays: Government labs often have backlogs. Solution: Plan testing early and consider private labs approved by CDSCO.
Audit Non-Compliance: Facilities may not meet notified body standards initially. Solution: Conduct internal mock audits and remediate gaps before formal audit.
Query Response Delays: Slow response to queries prolongs approval. Solution: Assign dedicated regulatory personnel to track and respond promptly.
Expert Consultation and Support
With our deeply rooted expertise, we offer end-to-end assistance including:
- Gap analysis of existing documentation
- Preparation of Device and Plant Master Files
- Liaison with CDSCO officials and notified bodies
- Audit readiness and mock inspections
- Post-license compliance and vigilance support
Our personalized approach has enabled 500+ manufacturers and importers to successfully navigate the CDSCO system efficiently.
Getting Started with Your CDSCO License Application
- Assess your device classification to confirm Class B status.
- Gather all technical and quality documents, prioritizing Device Master File and Risk Management File.
- Initiate the test license (MD13) application via the CDSCO MD Online Portal.
- Plan and schedule product testing at approved laboratories.
- Prepare for the notified body audit by reviewing your QMS and manufacturing site.
- Submit manufacturing license application (Form MD3) once test license and testing are complete.
- Maintain open communication with CDSCO and promptly address any queries.
Starting with a clear roadmap and expert guidance ensures your endoscopic electrosurgical electrode/submucosal lift needle enters the Indian market smoothly and compliantly.
For personalized support tailored to your unique circumstances, connect with us today to leverage our 25+ years of CDSCO licensing expertise.
