CDSCO License for Endoscopic electrosurgical biopsy/resection kit, partial-thickness
Medical Device Information
Intended Use
A collection of devices designed to be inserted through a compatible endoscope to obtain a mucosal tissue biopsy and/or therapeutic resection of upper gastrointestinal (GI) tract tissue, typically during endoscopic retrograde cholangiopancreatography (ERCP) procedures.
Comprehensive Guide to CDSCO Licensing for Endoscopic Electrosurgical Biopsy/Resection Kits (Class C)
Navigating the regulatory landscape in India for medical devices can be daunting, especially for advanced gastroenterology tools like the Endoscopic Electrosurgical Biopsy/Resection Kit, partial-thickness. With over 25 years of experience assisting 500+ companies, we understand the critical nuances involved in acquiring CDSCO licenses for such Class C devices. This kit, designed for mucosal tissue biopsy and therapeutic resection during ERCP procedures, falls under a stringent regulatory framework to ensure patient safety and device efficacy.
CDSCO Regulatory Framework for Endoscopic Electrosurgical Biopsy Kits
The Central Drugs Standard Control Organization (CDSCO) governs medical device registration and licensing in India. Since the notification dated 27.09.2021 (29/Misc./03/2020-DC (182)), the Endoscopic Electrosurgical Biopsy/Resection Kit is classified as a Class C device under the medical device rules. This classification mandates a centralized approval process under the MD9 license, regulated by the Central Licensing Authority (CLA).
Risk Classification and License Requirements for Class C Devices
Class C devices, including our biopsy/resection kit, are considered moderate to high risk, requiring rigorous scrutiny. The MD9 manufacturing license is mandatory for domestic manufacturers, involving thorough testing, audits, and compliance with Indian regulatory standards. Importers likewise need the MD15 import license to legally bring these devices into the Indian market.
Manufacturing License Process (MD9) for Class C Devices
The MD9 license process is a multi-stage procedure that typically spans 4 to 5 months:
Test License Application (Form MD13): Initiate by applying for a test license, allowing you to produce samples for laboratory testing. This step takes approximately 1.5 to 2 months.
Product Testing: Samples must be tested in CDSCO-approved labs. For our device, testing focuses on biocompatibility, electrical safety, and performance validation. Refer to the Testing Laboratories list for approved facilities.
Documentation Preparation: Concurrently, prepare the comprehensive documentation package including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application Submission (Form MD7): Submit your application via the CDSCO MD Online Portal with all supporting documents.
CDSCO Inspection Audit: Inspectors will conduct an on-site audit assessing compliance with Good Manufacturing Practices (GMP) and Quality Management Systems (QMS).
Query Resolution: Address any observations or deficiencies raised during audit and document review.
Grant of MD9 License: Upon satisfactory compliance, the MD9 license will be issued.
For detailed guidance, our MD9 License Guide offers step-by-step insights.
Manufacturing License Documents Required
To ensure a smooth application, gather the following critical documents:
- Company Constitution & Incorporation Certificate
- Proof of ownership or lease of manufacturing premises
- Technical Staff qualifications and experience
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design and specifications. Explore our Device Master File guide.
- Plant Master File outlining manufacturing processes and facilities. See our Plant Master File guide.
- Essential Principles Checklist demonstrating conformity with Indian regulations
- Risk Management File documenting hazard analysis and mitigation strategies. Our Risk Management resource can assist.
- Test Reports from CDSCO-approved labs
- Product labels and Instructions for Use (IFU)
- Quality Management System documentation, preferably ISO 13485:2016 compliant
Import License Process (MD15) for Class C Devices
If you plan to import the Endoscopic Electrosurgical Biopsy Kit, the MD15 import license is required, managed by the Central Licensing Authority. The process typically takes 5 to 6 months and involves:
- Comprehensive documentation preparation, including existing manufacturing licenses, Free Sale Certificate, ISO 13485 certification, CE mark or equivalent, Device and Plant Master Files
- Submission of application on the CDSCO MD Online Portal
- Addressing any queries raised by the CDSCO
- Final grant of the import license (Form MD15)
Note that unlike the MD9 process, a test license is not required prior to application.
Import License Documents Required
- Valid Manufacturing License from country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent regulatory approval
- Device Master File
- Plant Master File
- Wholesale license for distribution in India
- Company Constitution and Importer details
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| MD9 License Application & Audit | 1.5 - 2 months |
| Total Manufacturing License | Approx 4 - 5 months |
| Import License (MD15) | Approx 5 - 6 months |
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) |
|---|---|---|
| MD9 (Class C) | 50,000 | 1,000 |
| MD15 Import License | USD Equivalent of 3,000 | USD Equivalent of 1,500 |
Note: Fees are payable online during application submission via the CDSCO portal.
Common Challenges and Solutions
Challenge: Delays due to incomplete documentation or non-compliance with Indian Essential Principles.
Solution: Engage early with regulatory consultants to audit your Device Master File and Risk Management File. Preparing a robust dossier reduces back-and-forth queries.
Challenge: Difficulty in scheduling audits with notified bodies or CDSCO inspectors.
Solution: Plan well ahead and coordinate with notified bodies listed on the CDSCO Notified Bodies list to secure timely audits.
Challenge: Extended timelines due to product testing failures.
Solution: Conduct pre-testing in accredited labs to identify issues before formal CDSCO testing.
Expert Consultation and Support
With our deep industry expertise, we assist manufacturers and importers at every step—from initial classification to dossier preparation, submission, and audit management. Our tailored approach helps mitigate risks, shorten timelines, and ensure compliance.
Getting Started with Your CDSCO License Application
Confirm Device Classification: Verify your device as Class C using resources like our Medical Device Classification guide.
Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
Arrange Product Testing: Coordinate with CDSCO-approved labs to schedule testing immediately after test license approval.
Compile Documentation: Begin assembling your Device Master File, Plant Master File, and other essential files while testing is underway.
Schedule Audit Preparation: Engage with a notified body or CDSCO inspectors early to plan for your facility audit.
Submit MD9 License Application: Once testing and documentation are complete, submit Form MD7 online.
Prepare for Queries: Maintain a responsive communication channel for swift resolution of any CDSCO queries.
By following this structured approach and leveraging expert guidance, manufacturers and importers of Endoscopic Electrosurgical Biopsy Kits can confidently navigate the CDSCO licensing process and successfully enter the Indian market.
For personalized assistance, reach out to our regulatory consultancy team with decades of proven success in medical device approvals.
