CDSCO License for Endoscopic overtube, reusable

Comprehensive Guide to CDSCO Licensing for Reusable Endoscopic Overtubes (Class B Medical Devices)

Navigating the regulatory landscape for medical devices in India can be complex, especially for specialized devices like the reusable endoscopic overtube. As a tubular device designed to assist flexible endoscopes in gastrointestinal procedures, this device falls under the gastroenterology category and is classified as a Class B medical device by CDSCO. With over 25 years of regulatory consulting experience and having supported more than 500 companies, we provide you with a step-by-step, practical roadmap to secure your CDSCO manufacturing or import license efficiently and compliantly.

CDSCO Regulatory Framework for Endoscopic Overtubes

The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India, including reusable endoscopic overtubes. The regulatory framework mandates that manufacturers and importers obtain the necessary licenses before marketing these products. Since the overtube is a reusable Class B device notified under 29/Misc./03/2020-DC (182) dated 27.09.2021, it must comply strictly with the Medical Device Rules, 2017.

Risk Classification and License Requirements for Class B Devices

Reusable endoscopic overtubes are classified as Class B due to their moderate risk profile, requiring a Manufacturing License MD5 granted by the State Licensing Authority. For importers, an Import License MD15 issued by the Central Licensing Authority is compulsory. Class B devices demand comprehensive documentation, testing, and compliance with essential principles to ensure safety and performance.

Manufacturing License Process for Reusable Endoscopic Overtubes (MD5)

The manufacturing license process for Class B devices involves several key stages:

Test License (Form MD13): Initially, manufacturers must apply for a test license, which takes approximately 1.5 to 2 months. This license authorizes the production of limited batches for testing purposes.
Product Testing: Samples must be tested at CDSCO-approved government laboratories to validate compliance. Refer to the list of government testing laboratories for approved facilities.
Document Preparation: Compilation of required documents including technical files and quality management system records.
Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal.
Audit by Notified Body: A mandatory audit conducted by a CDSCO-approved notified body to verify manufacturing premises and quality systems. You can check the list of notified bodies here.
Resolution of Queries: Address any queries or observations raised by CDSCO or the notified body promptly.
Grant of License (Form MD5): Upon satisfactory review, the manufacturing license is granted.

The entire process generally takes about 3 to 4 months.

Manufacturing License Documents Required for Endoscopic Overtubes

To meet CDSCO requirements, prepare the following documents meticulously:

Company Constitution (Incorporation certificate, partnership deed, etc.)
Proof of Ownership or Lease of Manufacturing Premises
Technical Staff Details (Qualification and experience certificates)
Fire NOC & Pollution Control Certificate
Device Master File (DMF) detailing design, materials, intended use, and performance data. Our Device Master File guide offers practical insights.
Plant Master File (PMF) describing manufacturing processes and facilities. See our Plant Master File guide for templates.
Essential Principles Checklist confirming compliance with safety and performance standards
Risk Management File outlining risk analysis and mitigation strategies as per ISO 14971. Learn more about risk management implementation.
Test Reports from government-approved laboratories
Product Labels and Instructions for Use (IFU)
Quality Management System (QMS) Documents (ISO 13485 certification and SOPs)

Import License Process for Reusable Endoscopic Overtubes (MD15)

For importers, obtaining an MD15 license is mandatory. The process is centralized and slightly longer, typically taking 5 to 6 months. Key steps include:

Document Preparation: Gather all required documents including manufacturing licenses from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and device master files.
Application Submission (Form MD14): File your application via the CDSCO MD Online Portal.
Queries Resolution: Respond promptly to any departmental queries.
Grant of License (Form MD15): Upon satisfactory evaluation, the import license is granted.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 Certification
CE Certificate or equivalent (if applicable)
Device Master File and Plant Master File
Wholesale License
Company Constitution Documents

Timeline and Processing Duration

License Type	Process Duration	Key Milestones
MD5 (Manufacturing)	3-4 months	Test License (1.5-2 months), Testing, Audit, Query Resolution
MD15 (Import)	5-6 months	Document Prep, Application, Query Resolution

Government Fees and Cost Breakdown

MD5 License (Class B):
- Application Fee: Rs. 5,000
- Per Product Fee: Rs. 500
MD15 Import License (Class B):
- Site Fee: USD 2,000
- Per Product Fee: USD 1,000

Additional costs to consider include notified body audit fees (varies by body), testing laboratory charges, and professional consulting fees.

Common Challenges and Practical Solutions

Delays in Testing: Government labs may have backlogs. Plan sample submission early and consider pre-testing with accredited private labs for initial validation.
Incomplete Documentation: Ensure all files, especially Device Master File and Risk Management File, are comprehensive and up-to-date. Utilizing our detailed guides helps avoid common pitfalls.
Audit Non-compliance: Prepare your quality system and manufacturing sites meticulously before notified body audits. Conduct internal mock audits to identify gaps.
Query Resolution Delays: Respond quickly and clearly to CDSCO queries to avoid processing delays.

Expert Consultation and Support

With over 25 years of expertise and having assisted 500+ companies, we offer:

End-to-end application preparation and submission
Device and plant master file development
Quality management system implementation
Audit readiness and mock inspections
Liaison with CDSCO and notified bodies

Our tailored consultancy accelerates approvals and ensures compliance, reducing your time-to-market.

Getting Started with Your CDSCO License Application for Reusable Endoscopic Overtubes

Assess Device Classification: Confirm your device as Class B and understand applicable regulations.
Prepare Test License Application: Compile technical data and apply for test license (Form MD13) via the CDSCO MD Online Portal.
Plan Testing Strategy: Identify government-approved labs early for timely sample testing.
Develop Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides to ensure completeness.
Engage a Notified Body: Schedule audits with notified bodies from the official list.
Submit Manufacturing License Application (Form MD3): After successful testing and audit, upload all documents and apply via the CDSCO portal.
Prepare for Query Resolution: Assign a dedicated team member to monitor and respond to CDSCO queries promptly.

By following these actionable steps and leveraging our proven expertise, manufacturers and importers of reusable endoscopic overtubes can streamline their regulatory journey and successfully enter the Indian market.

For personalized assistance and to discuss your specific device requirements, reach out to our regulatory consultants today.

CDSCO License for Endoscopic overtube, reusable

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