CDSCO License for Gastrointestinal endoscopic clip cutter
Medical Device Information
Intended Use
A sterile device intended to be used in combination with a generator to remove a gastrointestinal endoscopic clip.
Comprehensive Guide to CDSCO Licensing for Gastrointestinal Endoscopic Clip Cutter (Class C Medical Device)
As a trusted regulatory consultancy with over 25 years of experience and over 500 successful CDSCO license approvals, we understand the complexities involved in bringing your Gastrointestinal Endoscopic Clip Cutter to the Indian market. This sterile, Class C device — intended for use with a generator to remove gastrointestinal endoscopic clips — falls under the gastroenterology category and is regulated under CDSCO Notification 29/Misc./03/2020-DC (182) dated 27.09.2021.
Navigating the regulatory landscape for such a device requires a clear understanding of the CDSCO framework, timelines, documentation, and costs. Our goal is to provide you with actionable insights to streamline your MD9 license application process.
CDSCO Regulatory Framework for Gastrointestinal Endoscopic Clip Cutter
The Central Drugs Standard Control Organization (CDSCO) governs the import and manufacture of medical devices in India. Your device, classified as Class C, is considered a moderate-to-high risk device and thus requires approval from the Central Licensing Authority.
India’s medical device regulations align with international standards, emphasizing safety, efficacy, and quality management. The recent notification dated 27.09.2021 explicitly includes gastrointestinal endoscopic clip cutters under the regulatory ambit, making compliance mandatory for market entry.
For detailed classification, refer to our Medical Device Classification guide.
Risk Classification and License Requirements
- Device Risk Class: C (Moderate-High risk)
- Regulatory Pathway: MD9 Manufacturing License
- Governing Authority: CDSCO Central Licensing Authority
Class C devices require a more stringent evaluation compared to Class A or B, including product testing, quality audits, and detailed documentation.
Manufacturing License Process (MD9)
The MD9 license process is comprehensive and typically spans 4 to 5 months. Below is the stepwise approach:
- Test License (MD13) Application:
- Duration: 1.5 to 2 months
- Purpose: Allows manufacturing for testing before full license issuance
- Product Testing:
- Conducted at CDSCO-approved labs (see list of Testing Laboratories)
- Testing confirms compliance with Indian standards and Essential Principles
- Document Preparation:
- Compilation of technical files, quality management system (QMS) documents, risk management, and others
- Submission of MD9 Application (Form MD7):
- Submitted via the CDSCO MD Online Portal
- Inspection and Audit:
- Conducted by CDSCO inspectors
- Resolution of Queries:
- Promptly address any observations or requests
- License Grant:
- Issuance of MD9 license on Form MD9 upon satisfaction of all requirements
For an in-depth overview, consult our MD9 License Guide.
Manufacturing License Documents Required for Gastrointestinal Endoscopic Clip Cutter
The documentation for Class C devices is extensive and must be precise and complete:
- Company Constitution Documents (Incorporation certificate, PAN, GST)
- Proof of Ownership/Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire NOC & Pollution Control Board NOC
- Device Master File (DMF): Detailed device design, manufacturing process, and specifications (Device Master File Guide)
- Plant Master File (PMF): Facility layout, equipment, and quality systems (Plant Master File Guide)
- Essential Principles Checklist: Demonstrate compliance with Indian Essential Principles
- Risk Management File: Per ISO 14971 standards (Risk Management)
- Test Reports: From CDSCO-approved testing labs
- Labels and Instructions for Use (IFU): As per Indian regulatory requirements
- Quality Management System Documents: ISO 13485:2016 certification and procedures
Import License Process (MD15) for Gastrointestinal Endoscopic Clip Cutter
If you are an importer rather than a manufacturer, the MD15 import license is mandatory. The process typically takes 5 to 6 months and involves:
- Document preparation including manufacturing license, Free Sale Certificate, ISO 13485, CE certificate
- Application submission via CDSCO MD Online Portal
- Review and query resolution
- License issuance on Form MD15
Refer to our Import License Guide for detailed steps.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution and Address Proof
Timeline and Processing Duration
| Stage | Timeline |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | Concurrent with Testing |
| Application Review | 1 to 1.5 months |
| Inspection & Audit | 2 to 3 weeks |
| Query Resolution & Grant | 2 to 4 weeks |
Total Duration for MD9 License: Approximately 4 to 5 months
Government Fees and Costs
- MD9 License Application Fee: ₹50,000 per application
- Product Fee: ₹1,000 per product
- Test License Fee: Included in application costs
Note: Additional costs may arise from notified body audits, product testing, and consultancy services.
Common Challenges and Solutions
- Incomplete Documentation: Ensure meticulous preparation of Device and Plant Master Files with cross-referenced data.
- Delayed Product Testing: Engage with CDSCO-approved labs early; check the Testing Laboratories List for availability.
- Audit Non-Compliance: Prepare for audits by aligning QMS with ISO 13485 and Essential Principles checklist.
- Query Management: Respond promptly and with detailed evidence to avoid delays.
Expert Consultation and Support
With over 500 successful CDSCO licensing projects, our expertise helps you:
- Strategize regulatory pathways tailored to your device
- Prepare robust technical dossiers and master files
- Liaise with CDSCO and notified bodies
- Expedite audits and inspections
We encourage early engagement to minimize risks of rejection or delays.
Getting Started with Your CDSCO License Application
- Classify Your Device: Confirm Class C status using the Medical Device Classification tool.
- Prepare Test License Application: Apply for MD13 via the CDSCO MD Online Portal.
- Coordinate Product Testing: Schedule with approved labs early to prevent bottlenecks.
- Compile Documentation: Develop your Device Master File, Plant Master File, risk management, and QMS documents.
- Submit MD9 Application: Use Form MD7 on the CDSCO portal.
- Prepare for Audit: Ensure your manufacturing site and documentation meet CDSCO requirements.
- Respond to Queries: Maintain clear communication with CDSCO and notified bodies.
Embarking on your regulatory journey with a clear roadmap and expert guidance ensures a smoother path to market authorization. Contact us to start your application process for your Gastrointestinal Endoscopic Clip Cutter today.
