CDSCO License for Forceps, endoscopic
Medical Device Information
Intended Use
Grasping Forceps device is intended to be used to grasp tissue, retrieve foreign bodies, and remove tissue from within the gastrointestinal tract.
Comprehensive Guide to CDSCO Licensing for Endoscopic Forceps (Class B Medical Device)
Navigating the regulatory landscape for medical devices in India requires precision, knowledge, and experience. As a specialized medical device regulatory consultancy with over 25 years of expertise and a track record of supporting 500+ companies, we provide you with an in-depth guide tailored specifically for obtaining the CDSCO license for Forceps, endoscopic — a Class B medical device under the catheter category.
Introduction: Understanding Endoscopic Forceps and Regulatory Importance
Endoscopic forceps are indispensable instruments designed to grasp tissue, retrieve foreign bodies, or remove tissue within the gastrointestinal tract. Given their direct interaction with internal body tissues, they are classified as Class B devices under India’s medical device regulations, necessitating a rigorous licensing process to ensure patient safety and compliance.
Securing a CDSCO license for manufacturing or importing this device is mandatory before it can be marketed in India. This regulatory compliance not only ensures adherence to Indian standards but also builds trust with healthcare providers and end users.
CDSCO Regulatory Framework for Forceps, Endoscopic
The Central Drugs Standard Control Organization (CDSCO) governs the regulation of medical devices in India under the Medical Device Rules, 2017. For your device, classified as Class B, the applicable license is the MD5 Manufacturing License, issued by the State Licensing Authority.
The license for import falls under the MD15 Import License, granted by the Central Licensing Authority.
The governing notification for this device is 29/Misc/3/2017-DC (292) dated 06.06.2018, which aligns the device under the catheter category.
Risk Classification and License Requirements for Endoscopic Forceps
| Risk Class | License Type | Licensing Authority | Approximate Timeline | Fees (INR) |
|---|---|---|---|---|
| Class B | MD5 | State Licensing Authority | 3-4 months | Rs 5,000 + Rs 500 per product |
The Class B classification mandates obtaining an MD5 license via Form MD3 for manufacturing. The license process involves product testing, quality management system (QMS) audits, and compliance with essential principles.
Manufacturing License Process (MD5) for Endoscopic Forceps
Application for Test License (Form MD13): Initiate by applying for a test license, which permits sample testing of your endoscopic forceps. This process typically takes 1.5 to 2 months.
Product Testing: Submit device samples to CDSCO-approved government testing laboratories. For a device like forceps, testing includes biocompatibility, sterilization validation, and mechanical performance.
Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), risk management files, and quality management system manuals.
Application for Manufacturing License (Form MD3): Submit your application for the MD5 license on the CDSCO MD Online Portal.
Audit by Notified Body: The notified body conducts an onsite audit of your manufacturing premises and QMS. Refer to the list of notified bodies to select an authorized auditor.
Resolution of Queries: Address any queries raised by the department or notified body promptly.
Grant of License (Form MD5): Upon successful audit and document review, the license is granted.
For a detailed walkthrough, see our comprehensive MD5 License Guide.
Manufacturing License Documents Required for Forceps, Endoscopic
Prepare the following essential documents to streamline your MD5 application:
- Company Constitution (Memorandum & Articles of Association)
- Proof of Ownership or Lease of Premises
- Technical Staff Qualifications and Experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Includes design, specifications, and manufacturing process. Our Device Master File guide elaborates on this.
- Plant Master File (PMF): Details manufacturing facilities and equipment. See our Plant Master File guide for tips.
- Essential Principles Checklist
- Risk Management File: Demonstrating compliance with ISO 14971 standards. Learn more about risk management.
- Test Reports from Government Approved Labs (Testing Laboratories)
- Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification preferred)
Import License Process (MD15) for Endoscopic Forceps
If importing endoscopic forceps into India, you must obtain an MD15 Import License from the Central Licensing Authority. This process is slightly different:
No Test License Required: Unlike manufacturing, import does not require a test license.
Document Preparation: Gather all relevant documents, including the manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, wholesale license, and company constitution.
Application Submission: File the application using Form MD14 through the CDSCO MD Online Portal.
Query Resolution: Respond to any department queries.
License Grant: Typically takes 5-6 months.
Refer to our Import License Guide for further details.
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
- Plant Master File
- Wholesale License
- Company Constitution
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Document Preparation | 2 – 3 weeks |
| Application Submission & Audit | 1.5 – 2 months |
| Query Resolution & License Grant | 2 – 4 weeks |
Total time for MD5 license: Approximately 3-4 months.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 Manufacturing | Rs 5,000 | Rs 500 |
For a company planning to manufacture multiple variants of endoscopic forceps, fees multiply accordingly.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all documents are accurate and complete; cross-verify with CDSCO checklists.
- Delays in Product Testing: Coordinate early with approved laboratories to schedule testing promptly.
- Audit Non-compliance: Prepare your facility and QMS thoroughly; conduct internal audits before notified body inspection.
- Query Management: Respond to departmental queries comprehensively and promptly to avoid delays.
Expert Consultation and Support
With over 25 years of experience and a portfolio of 500+ successful CDSCO licensing projects, we specialize in guiding manufacturers and importers through every step — from documentation to audits and query management. Our hands-on approach ensures smoother approvals and faster market entry.
Getting Started with Your CDSCO License Application for Endoscopic Forceps
Evaluate your Device Classification: Confirm your device’s risk class and licensing requirements using our Medical Device Classification resource.
Collect and Prepare Documents: Begin assembling your DMF, PMF, risk management files, and QMS documentation.
Apply for Test License (MD13) via CDSCO MD Online Portal: Start your application on the official portal.
Coordinate Product Testing: Engage with government-approved testing laboratories early to avoid bottlenecks.
Plan for Audit: Schedule and prepare your manufacturing site for notified body inspection.
Submit MD5 License Application (Form MD3): Once testing and audit readiness are complete.
Maintain Open Communication: Keep track of your application status and promptly address any queries.
By following these practical steps and engaging expert support, manufacturers and importers of endoscopic forceps can confidently navigate the CDSCO licensing journey and successfully enter the Indian medical device market.
