CDSCO License for Flexible video pancreatoscope
Medical Device Information
Intended Use
An endoscope with a flexible inserted portion intended for the visual examination and treatment in the pancreas.
Comprehensive Guide to CDSCO Licensing for Flexible Video Pancreatoscope (Class B Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully supported more than 500 medical device companies in India, we understand the complexities manufacturers and importers face when navigating CDSCO licensing. This guide provides an in-depth, practical pathway for obtaining the CDSCO manufacturing license (MD5) for the Flexible Video Pancreatoscope, a Class B gastroenterology device.
Introduction: Understanding the Flexible Video Pancreatoscope and Regulatory Importance
The Flexible Video Pancreatoscope is a specialized endoscopic device with a flexible inserted portion designed to visually examine and treat conditions within the pancreas. Given its invasive nature and critical application in gastroenterology, it is classified as a Class B device under Indian regulations.
Securing the appropriate CDSCO license is mandatory to manufacture or import this device for commercial distribution in India. Without this, your product cannot legally enter the Indian market, risking penalties and business disruption.
CDSCO Regulatory Framework for Flexible Video Pancreatoscope
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules, 2017. The Flexible Video Pancreatoscope falls under Class B, which requires obtaining an MD5 manufacturing license granted by the State Licensing Authority.
The regulatory framework involves multiple steps including test license acquisition, product testing by government-approved labs, document preparation, audit by notified bodies, and final license grant.
Risk Classification and License Requirements
- Device Risk Class: B (Low Moderate Risk)
- License Type: MD5 Manufacturing License (Application Form MD3)
- Licensing Authority: State Licensing Authority
- Notification Reference: 29/Misc./03/2020-DC (182) dated 27.09.2021
You can verify your device’s classification on our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Flexible Video Pancreatoscope
Test License Application (Form MD13): The process begins with applying for a test license, which permits product testing and initial audits. It usually takes about 1.5 to 2 months for approval.
Product Testing: Testing must be conducted in CDSCO-approved laboratories. The list of testing laboratories can guide you in selecting an authorized lab.
Document Preparation: Prepare comprehensive documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Essential Principles checklist.
License Application (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: An audit by a notified body ensures compliance with regulatory requirements. Refer to the notified bodies list for approved auditors.
Query Resolution: Address any queries or deficiencies raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory review, CDSCO issues the manufacturing license.
Manufacturing License Documents Required for Flexible Video Pancreatoscope
- Company Constitution Documents: Incorporation certificate, partnership deed, etc.
- Proof of Ownership/Lease of Premises: To verify the manufacturing site.
- Technical Staff Credentials: Qualifications and experience of key personnel.
- Fire NOC and Pollution NOC: Compliance with local safety and environmental standards.
- Device Master File (DMF): Detailed device specifications, design, and performance data. Our Device Master File guide offers a stepwise approach.
- Plant Master File (PMF): Manufacturing process, quality assurance, and facility details. See our Plant Master File guide for practical tips.
- Essential Principles Checklist: To demonstrate conformity with Indian and international standards.
- Risk Management File: Including hazard analysis and mitigation strategies. Learn more about risk management implementation.
- Test Reports: From government-approved laboratories.
- Labels and Instructions for Use (IFU): Compliant with CDSCO labeling requirements.
- Quality Management System (QMS) Documents: Typically ISO 13485 certification and related SOPs.
Import License Process (MD15) – Note for Importers
If you are an importer looking to bring the Flexible Video Pancreatoscope into India, an MD15 import license is required. This is granted by the Central Licensing Authority and typically takes 5-6 months. Unlike manufacturing, a test license is not mandatory here.
Required documents include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 and CE Certificates
- Device Master File and Plant Master File
- Wholesale license and company constitution
You can find a detailed Import License guide for further insights.
Timeline and Processing Duration for MD5 License
| Step | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 2 - 3 weeks |
| Application Processing | 4 - 6 weeks |
| Audit and Inspection | 3 - 4 weeks |
| Query Resolution & Final Grant | 2 - 3 weeks |
Total Estimated Time: Approximately 3 to 4 months from start to license grant.
Government Fees and Costs
- Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product (Flexible Video Pancreatoscope counts as one product)
- Testing Costs: Varies by lab and tests required, typically Rs. 50,000 to Rs. 1,00,000
- Audit Fees: Payable to the notified body, approximately Rs. 1,00,000 - Rs. 2,00,000 depending on scope
Budgeting for these costs early on ensures smooth financial planning.
Common Challenges and Solutions
- Delayed Test License Approval: Initiate the MD13 process early and ensure all documentation is error-free.
- Incomplete Documentation: Use our detailed templates for DMF and PMF to avoid rejection.
- Audit Non-Conformities: Conduct internal audits and gap assessments before the notified body visit.
- Query Backlogs: Assign dedicated personnel to promptly address CDSCO queries.
Expert Consultation and Support
Given the complexity and rigorous compliance requirements, engaging experienced regulatory consultants can significantly reduce timelines and risks. We offer end-to-end support from document preparation to audit readiness and query resolution, ensuring a stress-free licensing journey.
Getting Started with Your CDSCO License Application
- Register on the CDSCO MD Online Portal to create your company profile and application.
- Initiate the Test License Application (Form MD13) and simultaneously prepare your testing schedule with a CDSCO-approved laboratory.
- Compile your Device and Plant Master Files, ensuring all technical and quality management documents are up to date.
- Plan your notified body audit by selecting an auditor from the official notified bodies list.
- Maintain open communication with CDSCO and your auditor to quickly resolve any queries or observations.
By following this expert roadmap, manufacturers and importers of the Flexible Video Pancreatoscope can confidently navigate the CDSCO regulatory landscape and successfully enter the Indian market.
For personalized support and comprehensive compliance solutions, feel free to connect with our expert team who have empowered 500+ medical device companies in India.
