CDSCO License for Endoscopic spray catheter

Comprehensive Guide to CDSCO Licensing for Endoscopic Spray Catheters (Class B Medical Devices)

As seasoned regulatory consultants with over 25 years of experience and having successfully supported 500+ companies, we understand the complexities involved in obtaining CDSCO licenses for medical devices in India. The Endoscopic Spray Catheter, categorized under gastroenterology devices and classified as a Class B medical device, requires meticulous adherence to CDSCO regulations for smooth market entry.

Understanding the Endoscopic Spray Catheter and Regulatory Importance

An Endoscopic Spray Catheter is a sterile, flexible tube designed to be used with endoscopes such as colonoscopes to deliver fluids in spray form, commonly dyes for mucosal coloration. Given its direct interaction with internal body tissues, ensuring safety, sterility, and regulatory compliance is critical. The CDSCO notification number 29/Misc./03/2020-DC (182), dated 27.09.2021, formally regulates this device in India.

Regulatory compliance not only safeguards patient health but also facilitates efficient market access and builds trust among healthcare providers.

CDSCO Regulatory Framework for Endoscopic Spray Catheters

India’s regulatory oversight of medical devices is governed by the Central Drugs Standard Control Organization (CDSCO). Devices like the Endoscopic Spray Catheter fall under the purview of the Medical Device Rules (MDR) 2017, with classifications based on risk.

For Class B devices such as this catheter, the licensing authority is the State Licensing Authority, and the applicable license is the MD5 Manufacturing License.

Risk Classification and License Requirements

• Risk Class: B (Low Moderate Risk)
• License Type: MD5 (Manufacturing License for Class A & B devices)
• Application Form: MD3
• Authority: State Licensing Authority
• Process Duration: Approximately 3-4 months
• Fees: INR 5,000 + INR 500 per product

This classification ensures a balanced regulatory approach, emphasizing product safety without excessive procedural burdens.

Detailed Manufacturing License Process (MD5) for Endoscopic Spray Catheters

Obtaining an MD5 license involves multiple stages:

1. Test License Application (Form MD13): You must first apply for a test license, which takes around 1.5-2 months to be granted.
2. Product Testing: Conduct product testing in government-approved laboratories to verify compliance with applicable standards.
3. Documentation Preparation: Prepare comprehensive documents including Device Master File, Plant Master File, Risk Management File, and other technical dossiers.
4. MD5 License Application (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
5. Audit by Notified Body: An audit by a notified body listed on the Notified Bodies List for MD5 Audit is mandatory.
6. Query Resolution: Respond promptly to any queries raised by the department or auditors.
7. Grant of License: Upon satisfying all requirements, the license is granted on Form MD5.

Essential Documents Required for MD5 License Application

For the Endoscopic Spray Catheter, the following documents must be prepared meticulously:

• Company Constitution Documents: Incorporation certificate, partnership deed, etc.
• Proof of Ownership/Rent Agreement: For manufacturing premises
• Technical Staff Credentials: Qualification and experience certificates
• Fire NOC & Pollution Control NOC: Relevant safety clearances
• Device Master File (DMF): Detailed technical specifications, manufacturing process, sterilization methods (Device Master File Guide)
• Plant Master File (PMF): Manufacturing facility details, quality assurance processes (Plant Master File Guide)
• Essential Principles Checklist: Compliance checklist aligning with MDR 2017
• Risk Management File: Demonstrating implementation of risk controls (Risk Management)
• Test Reports: From CDSCO-approved laboratories (Testing Laboratories)
• Labels and Instructions for Use (IFU): Clear, compliant labeling and user manuals
• Quality Management System Documents: ISO 13485 or equivalent documentation

Import License Process for Endoscopic Spray Catheters (MD15 License)

If you are an importer, the process differs:

• License Type: MD15 (Import License)
• Application Form: MD14
• Authority: Central Licensing Authority
• Processing Time: 5-6 months
• Fees: Varies by device class; for Class B, approx INR 2000 per site and INR 1000 per product

You must provide:

• Manufacturing License from the country of origin
• Free Sale Certificate
• CE Certificate
• ISO 13485:2016 certification
• Device and Plant Master Files
• Wholesale license
• Company Constitution Documents

Apply through the CDSCO MD Online Portal, ensuring all documents are in order to avoid delays. For more detailed steps, refer to our Import License Guide.

Timeline and Processing Duration

Timelines can vary based on the completeness of submissions and responsiveness to queries.

Government Fees and Costs

• Test License Fee: Included in initial application
• MD5 License Fee: INR 5,000 per application + INR 500 per product
• Testing Fees: Variable depending on the number of tests and laboratories
• Audit Fees: Payable to the notified body conducting audits

Investing in thorough documentation and pre-audit readiness can reduce rework costs.

Common Challenges and Practical Solutions

• Document Gaps: Incomplete Device or Plant Master Files delay approvals; utilize detailed templates and expert reviews.
• Testing Delays: Choose CDSCO-approved labs with shorter turnaround times.
• Audit Preparedness: Conduct internal audits before the notified body visit to preempt observations.
• Query Management: Maintain a dedicated team to respond promptly and comprehensively to CDSCO queries.

Our practical experience shows that proactive planning and expert consultation significantly smooth the pathway.

Expert Consultation and Support

With over two decades of specialized experience in CDSCO licensing, our team offers:

• Step-by-step guidance tailored to the Endoscopic Spray Catheter
• Comprehensive document preparation support
• Coordination with CDSCO officials and notified bodies
• Training on post-license compliance requirements

Our proven track record helps manufacturers and importers avoid common pitfalls and achieve timely approvals.

Getting Started with Your CDSCO License Application

1. Identify License Type: For a Class B Endoscopic Spray Catheter, prepare for an MD5 license.
2. Gather Core Documents: Begin with company constitution, premises proof, technical staff details, and initial quality documents.
3. Apply for Test License (MD13): Submit on the CDSCO MD Online Portal to kickstart testing.
4. Engage Approved Testing Labs: Schedule product testing early to avoid bottlenecks.
5. Prepare Master Files and Risk Documents: Use our Device Master File Guide and Risk Management resources.
6. Plan for Audit: Select a notified body from the Notified Bodies List and conduct a pre-audit.
7. Submit MD5 Application (Form MD3): After test license and successful testing, apply for manufacturing license.
8. Prepare for Queries: Assign a regulatory liaison to handle communications.

Starting early, maintaining transparency, and leveraging expert support ensures a smooth, efficient journey to CDSCO licensing for your Endoscopic Spray Catheter.

For tailored assistance, contact us to leverage our extensive expertise and streamline your regulatory compliance process.