CDSCO License for Anaesthesia catheter Luer connector
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
It is a device intended to create a mechanical union between an anaesthesia catheter and an external device, via a Luer connection.
Comprehensive Guide for CDSCO Licensing of Anaesthesia Catheter Luer Connector (Class A)
Navigating the regulatory pathway for medical devices in India requires precision, expertise, and a thorough understanding of CDSCO requirements. With over 25 years of experience and having supported 500+ companies in securing their CDSCO licenses, we offer you a detailed, actionable roadmap to obtain the MD5 manufacturing license for your Anaesthesia Catheter Luer Connector — a Class A device under the Anesthesiology category.
Understanding the Anaesthesia Catheter Luer Connector and Regulatory Importance
The Anaesthesia Catheter Luer Connector is a critical device designed to create a secure mechanical union between an anaesthesia catheter and an external device using a Luer connection. Despite its simple design, regulatory compliance is essential to ensure patient safety and market access within India. As per the CDSCO notification [29/Misc/03/2020-DC(177)] dated 12.07.2021, this device falls under Class A, mandating adherence to specific licensing protocols governed by the State Licensing Authority.
CDSCO Regulatory Framework for Anaesthesia Catheter Luer Connector
Under the Medical Device Rules (MDR) 2017, devices are classified based on risk, and Class A devices like the Anaesthesia Catheter Luer Connector require an MD5 license for manufacturing. This license validates your compliance with quality, safety, and efficacy standards mandated by CDSCO.
Manufacturers must apply through the CDSCO MD Online Portal and comply with audit and testing requirements before license approval.
Risk Classification and License Requirements
- Device Risk Class: A (Low risk)
- Applicable License: MD5 Manufacturing License
- Authority: State Licensing Authority
- Application Form: MD3
Class A devices are subject to a streamlined process but still require rigorous documentation, testing, and audit to ensure compliance.
Manufacturing License Process (MD5) for Anaesthesia Catheter Luer Connector
The MD5 license process involves several key steps:
Test License Application (Form MD13): Before full license application, obtain a test license to conduct necessary product testing. This typically takes 1.5 to 2 months.
Product Testing: Conduct all tests at CDSCO-approved government laboratories. You can find an updated list of Testing Laboratories here.
Document Preparation: Compile comprehensive documentation, including Device Master File, Plant Master File, Quality Management System (QMS) documents, and risk management files.
License Application (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: Engage with a notified body for the mandatory audit. Refer to the official Notified Bodies List to select an appropriate auditor.
Query Resolution: Address any queries or deficiencies raised by the department or notified body within stipulated timelines.
License Grant (Form MD5): Upon successful audit and query resolution, the MD5 license is issued.
Manufacturing License Documents Required for Anaesthesia Catheter Luer Connector
For a smooth licensing process, ensure the following documents are prepared and submitted:
- Company Constitution (Incorporation certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Qualification and Experience Certificates of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device specifications and manufacturing process (Device Master File Guide)
- Plant Master File (PMF) describing the manufacturing environment and facilities (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian MDR
- Risk Management File illustrating hazard identification and mitigation (Risk Management)
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification highly recommended)
Import License Process (MD15) – Not Applicable for Manufacturers
As a manufacturer of the Anaesthesia Catheter Luer Connector, your primary focus will be on obtaining the MD5 license. However, importers of this device into India require an MD15 license from the Central Licensing Authority. This license has a longer processing time (5-6 months) and different documentation requirements.
For importers interested in this device, detailed guidance is available in our Import License Guide.
Timeline and Processing Duration
| Process Step | Duration Estimate |
|---|---|
| Test License (Form MD13) | 1.5 to 2 months |
| Product Testing | 2 to 3 weeks |
| Document Preparation | 2 to 4 weeks |
| MD5 License Application | Submission on portal |
| Audit by Notified Body | 4 to 6 weeks |
| Query Resolution | 2 to 3 weeks |
| Total Estimated Time | 3 to 4 months |
Government Fees and Costs
| Fee Type | Cost (INR) |
|---|---|
| Application Fee | ₹5,000 |
| Per Product Fee | ₹500 |
Additional costs include testing fees at government labs and notified body audit fees, which vary by auditor.
Common Challenges and Solutions
- Delayed Testing Results: Plan testing schedules early and engage with CDSCO-approved labs promptly.
- Incomplete Documentation: Use comprehensive checklists, such as those provided in our MD5 License Guide, to avoid omissions.
- Audit Non-Compliance: Conduct pre-audit internal checks and ensure QMS adherence.
- Query Management: Maintain prompt communication with CDSCO and respond thoroughly to queries.
Expert Consultation and Support
Our team, with decades of experience and over 500 successful CDSCO license acquisitions, offers end-to-end support—from documentation to audit preparation and post-submission follow-up. Leveraging our expertise can significantly reduce your application timeline and minimize regulatory risks.
Getting Started with Your CDSCO License Application
To initiate your journey:
- Register on the CDSCO MD Online Portal.
- Apply for the Test License (Form MD13) immediately to kickstart product testing.
- Consult our Device Master File and Plant Master File guides to prepare robust documentation.
- Schedule product testing at approved labs early to avoid bottlenecks.
- Engage a notified body from the official list for the audit phase.
By following these practical, stepwise actions, you can efficiently secure your MD5 manufacturing license for the Anaesthesia Catheter Luer Connector and confidently enter the Indian medical device market.
For personalized assistance, feel free to contact our regulatory consultants who specialize in Class A medical devices and CDSCO licensing procedures.
