CDSCO License for Endoscopic Needle
Medical Device Information
Intended Use
Used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.
Introduction to Endoscopic Needle and Its Regulatory Importance
Endoscopic needles are critical disposable hypodermic devices designed for sampling targeted submucosal gastrointestinal lesions via the accessory channel of an ultrasound endoscope. As a Class B medical device under India’s CDSCO framework, regulatory compliance is essential for market access, patient safety, and legal distribution. With over 25 years of experience and having supported 500+ companies in navigating CDSCO licensing, we provide you with a clear roadmap to obtain your manufacturing or import license efficiently.
CDSCO Regulatory Framework for Endoscopic Needle (Class B)
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Drugs and Cosmetics Act, 1940. Endoscopic needles fall under Class B (low-moderate risk) as per the notified classification (Notification: 29/Misc/3/2017-DC (292), dated 06.06.2018). This classification mandates obtaining a manufacturing license (MD5) or import license (MD15) before commercial activities.
Risk Classification and License Requirements for Endoscopic Needle
- Device Name: Endoscopic Needle
- Risk Class: B (Low-Moderate Risk)
- License Type: MD5 Manufacturing License (for Indian manufacturers)
- Regulatory Authority: State Licensing Authority
- Application Form: MD3 (for manufacturing license)
Class B devices require compliance with essential principles of safety and performance, quality management system (QMS) implementation, and passing product testing in government-approved labs.
Manufacturing License Process (MD5) for Class B Endoscopic Needle
The entire MD5 license process typically spans 3 to 4 months and includes the following key steps:
- Test License Acquisition (Form MD13): Apply for a test license to manufacture and test sample devices; takes approximately 1.5 to 2 months.
- Product Testing: Get the endoscopic needle tested at CDSCO-approved labs to validate compliance with standards.
- Documentation Preparation: Compile comprehensive technical files, quality systems, and risk management documentation.
- License Application Submission (Form MD3): Submit the MD5 application through the CDSCO MD Online Portal.
- Notified Body Audit: Engage a notified body from the official Notified Bodies List to audit your manufacturing site and QMS.
- Query Resolution: Address any queries raised by the Licensing Authority or notified body promptly.
- License Grant (Form MD5): Upon successful completion, receive the manufacturing license.
Manufacturing License Documents Required for Endoscopic Needle
To ensure a smooth licensing process, prepare the following essential documents:
- Company Constitution (e.g., Incorporation Certificate)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Details
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF) detailing design, specifications, and manufacturing processes (Guide to Device Master Files)
- Plant Master File (PMF) outlining facility layout and equipment (PMF Guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating hazard analysis and mitigation (Risk Management Guide)
- Test Reports from CDSCO-approved laboratories (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation, preferably ISO 13485:2016 certified
Import License Process (MD15) for Endoscopic Needle
If you are an importer without manufacturing facilities in India, an MD15 license is mandatory. The process takes approximately 5 to 6 months and involves:
- Document preparation including valid manufacturing license from the country of origin, Free Sale Certificate, ISO 13485 certification, CE Certificates, Device Master File, Plant Master File, and Wholesale License.
- Application submission on CDSCO MD Online portal using Form MD14.
- Resolution of departmental queries.
- License grant on Form MD15.
Note: Test license is not required for importers, but strict documentation and quality compliance apply.
For detailed guidance, refer to our Import License Guide.
Import License Documents Required
- Valid Manufacturing License from Country of Origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or Equivalent
- Device Master File
- Plant Master File
- Wholesale License (Drug License for selling medical devices)
- Company Constitution Documents
Timeline and Processing Duration Summary
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 – 2 months | Testing samples in Govt. labs |
| Manufacturing (MD5) | 3 – 4 months total | Includes audit, query resolution, license grant |
| Import License (MD15) | 5 – 6 months | Document review, query resolution |
Government Fees and Cost Estimates
For Class B Endoscopic Needle manufacturing license (MD5):
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
For example, if registering 3 variants of endoscopic needles, total fee = 5,000 + (3 x 500) = Rs. 6,500.
Additional costs may include notified body audit fees (~Rs. 1,00,000 to Rs. 2,00,000), testing charges (~Rs. 50,000 to Rs. 1,00,000), and consultant fees if engaged.
Common Challenges and Solutions in Licensing Endoscopic Needles
- Delays in Testing: Government labs may have backlogs. To mitigate, submit test samples early and consider pre-testing at accredited private labs for internal validation.
- Incomplete Documentation: Missing or inconsistent technical files cause queries. Use detailed checklists and engage experienced consultants to review before submission.
- Audit Non-Compliance: Notified body audits may identify QMS gaps. Conduct internal audits and training beforehand.
- Query Management: Delayed responses to CDSCO queries prolong timelines. Assign dedicated personnel for prompt communication.
Expert Consultation and Support for Smooth Licensing
With our extensive experience facilitating over 500 successful CDSCO license approvals, we offer:
- Customized gap analysis of your technical and quality files
- End-to-end application drafting and submission on the CDSCO MD Online Portal
- Coordination with notified bodies and testing laboratories
- Pre-audit readiness assessments and training
- Timely query resolution and follow-up
Our practical insights save you months of potential delays and help avoid costly rejections.
Getting Started with Your CDSCO License Application for Endoscopic Needles
- Confirm Device Classification: Verify your device’s Class B status using the official Medical Device Classification guidelines.
- Prepare Test Samples: Manufacture representative samples for initial testing and obtain a test license (Form MD13).
- Engage Testing Labs: Submit samples to CDSCO-approved labs early to avoid bottlenecks.
- Compile Documentation: Develop your Device Master File, Plant Master File, Risk Management File, and QMS documents.
- Select Notified Body: Choose from the list of notified bodies for your audit.
- Submit Application: Apply through the CDSCO MD Online Portal with complete documents.
- Prepare for Audit and Queries: Plan internal readiness and designate a team for swift query handling.
Embarking on this regulatory journey with expert support ensures that your endoscopic needle reaches the Indian market compliantly and promptly. Contact us today to discuss your project and leverage our proven expertise in CDSCO licensing.
