CDSCO License for Endoscopic biopsy valve, non-sterile

Comprehensive Guide to CDSCO Licensing for Endoscopic Biopsy Valve (Non-Sterile) – Class A Medical Device

Navigating the regulatory landscape for medical devices in India demands precision, expertise, and a clear roadmap. With over 25 years of experience assisting more than 500 companies, we offer you an in-depth guide to obtaining the necessary CDSCO license for your Endoscopic Biopsy Valve, non-sterile—a Class A device under gastroenterology.

Introduction: Understanding Your Device and Its Regulatory Importance

The endoscopic biopsy valve is a specialized, non-sterile device designed to fit onto an endoscope's biopsy port. Its primary function is to enable seamless access or exchange of endoscopic instruments during procedures, while maintaining insufflation and minimizing leakage of biomaterial. Given its critical role in gastroenterological interventions, regulatory compliance ensures patient safety and device efficacy.

The Government of India, through CDSCO, mandates licensing for all medical devices, including Class A devices like your biopsy valve, to regulate quality, safety, and performance before market entry.

CDSCO Regulatory Framework for Endoscopic Biopsy Valve

This device falls under Class A (low risk) as per the Medical Device Classification norms. The regulatory oversight for Class A devices is managed by the State Licensing Authority.

Your device is notified under the gazette notification number 29/Misc./03/2020-DC (182) dated 27.09.2021, confirming its inclusion in the CDSCO regulatory ambit.

Risk Classification and License Requirements

• Risk Class: A (Low Risk)
• Applicable License: MD5 Manufacturing License
• Governing Authority: State Licensing Authority

Due to its Class A classification, your device's manufacturing license will be processed via the MD5 route, which consists of a thorough but streamlined procedure tailored for low-risk devices.

Manufacturing License Process (MD5) for Endoscopic Biopsy Valve

The MD5 license process is sequential and involves several key stages:

1. Test License Application (Form MD13): Before applying for the manufacturing license, you must obtain a test license, which permits sample production and testing.
2. Product Testing: Samples must be tested at government-approved laboratories listed on the Testing Laboratories portal.
3. Document Preparation: Compile all required documents, including technical and quality documentation.
4. Manufacturing License Application (Form MD3): Submit your application for the MD5 license via the CDSCO MD Online Portal.
5. Audit by Notified Body: A notified body will conduct an on-site audit of your manufacturing facility. You can review the list of notified bodies authorized for Class A device audits.
6. Resolution of Queries: Address any observations or requests for additional information from CDSCO or the notified body.
7. Grant of License (Form MD5): Upon successful completion, the license is issued.

Manufacturing License Documents Required

To ensure a smooth application, prepare the following documents meticulously:

• Company Constitution Documents: Incorporation certificate, memorandum, and articles of association.
• Proof of Premises Ownership or Lease: Valid documents establishing the manufacturing site.
• Technical Staff Details: Qualification and experience certificates of key technical personnel.
• Fire NOC & Pollution Control NOC: Safety and environmental clearances.
• Device Master File (DMF): Detailed device specifications, design, and manufacturing process. Our Device Master File guide can assist in precise preparation.
• Plant Master File (PMF): Details of manufacturing facilities and quality management systems; refer to our Plant Master File guide for insights.
• Essential Principles Checklist: Compliance with Indian medical device regulations.
• Risk Management File: Documentation of identified risks and mitigation strategies, following risk management best practices.
• Test Reports: From CDSCO-approved labs validating device safety and performance.
• Labels and Instructions for Use (IFU): As per regulatory format.
• Quality Management System (QMS) Documents: ISO 13485 certification and associated SOPs.

Import License Process (MD15) for Endoscopic Biopsy Valve

If importing this device, the process is managed by the Central Licensing Authority under the MD15 license. While your device is Class A, the import license application involves:

• Preparation of documents like Free Sale Certificate, ISO 13485, CE Certificate, Device and Plant Master Files.
• Submission of Form MD14 application via the CDSCO MD Online Portal.
• Resolution of any departmental queries.
• License grant typically takes 5-6 months.

For detailed guidance, our Import License Guide is a valuable resource.

Import License Documents Required

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

Timeline and Processing Duration

Planning your project timeline with these estimates helps avoid unexpected delays.

Government Fees and Costs

• Test License Fee (MD13): Included with application; nominal charges apply.
• MD5 License Application Fees: ₹5,000 per application.
• Product Fee: ₹500 per product.
• Audit and Testing Costs: Variable, depending on notified body and testing laboratory charges.

These fees are payable via the CDSCO MD Online Portal.

Common Challenges and Solutions

Challenge: Delays in product testing due to limited slots at government labs.

Solution: Early sample submission to approved labs and considering alternative notified testing labs can expedite the process.

Challenge: Non-compliance in documentation leading to repeated queries.

Solution: Engage expert consultants to review Device Master Files and Risk Management Files before submission.

Challenge: Scheduling audits with notified bodies.

Solution: Coordinate in advance with notified bodies listed on the official portal to secure audit dates.

Expert Consultation and Support

Leveraging expert regulatory consultants familiar with CDSCO procedures can drastically reduce your approval timeline. With our experience assisting 500+ manufacturers, we provide:

• Tailored document preparation and review.
• Coordination with notified bodies and testing labs.
• Query resolution and compliance advisory.

Our clients consistently experience smoother audits and faster license grants.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your device is Class A using resources like the Medical Device Classification guide.
2. Prepare Technical Documentation: Begin compiling your Device Master File, Plant Master File, and Risk Management documentation.
3. Register on CDSCO MD Online Portal: Create your account at https://cdscomdonline.gov.in/ and familiarize yourself with submission protocols.
4. Apply for Test License (MD13): Submit your initial application to start sample production and testing.
5. Engage Testing Labs Early: Coordinate with approved labs to ensure timely testing of your device.
6. Plan Manufacturing Audit: Schedule your notified body audit in parallel with document finalization.
7. Submit MD5 License Application: After successful testing and audit, apply for the manufacturing license.

By following these actionable steps and leveraging industry expertise, manufacturers and importers can confidently navigate the CDSCO licensing process for the Endoscopic Biopsy Valve, ensuring timely market access in India.

For further assistance or personalized consultancy, feel free to connect with our regulatory experts dedicated to your success.