CDSCO License for Intracardiac oximeter
Medical Device Information
Intended Use
A photoelectric device designed to transmit radiation at a known wavelength(s) through blood to measure the concentration of oxygen, or dye, within the heart based on the amount of reflected or scattered radiation.
Comprehensive Guide to CDSCO Licensing for Intracardiac Oximeter (Class B Medical Device)
Entering the Indian medical device market requires thorough compliance with the Central Drugs Standard Control Organization (CDSCO) regulations. For manufacturers and importers of Intracardiac Oximeters, a Class B anesthesiology device, obtaining the correct CDSCO license is crucial to ensure legal marketing and distribution in India.
At our consultancy, with over 25 years of experience and having supported 500+ companies, we understand the nuances involved in securing your MD5 manufacturing license and import license for devices like the Intracardiac Oximeter. This guide covers everything you need—from regulatory frameworks to practical tips—to streamline your application process.
Understanding the Intracardiac Oximeter and Its Regulatory Importance
An Intracardiac Oximeter is a sophisticated photoelectric device that measures oxygen concentration within the heart by transmitting and detecting radiation through blood. Classified under the anesthesiology category, this device is vital for critical patient monitoring during cardiac procedures.
Given its role and moderate risk profile, the device falls under Class B in the CDSCO risk classification system. This classification mandates specific regulatory requirements to ensure safety, efficacy, and quality before the device can be marketed.
CDSCO Regulatory Framework for Intracardiac Oximeters
The CDSCO governs medical device approval through a structured licensing framework. For Class B devices like the Intracardiac Oximeter, the State Licensing Authority issues the MD5 license following a detailed evaluation process.
The regulatory pathway includes:
- Obtaining a Test License (Form MD13)
- Product testing at government-approved laboratories
- Preparing comprehensive documentation including Device and Plant Master Files
- Application submission (Form MD3 for MD5 license)
- Notified Body audit
- Resolution of queries from CDSCO or audit bodies
- Final license grant (Form MD5)
Risk Classification and License Requirements for Intracardiac Oximeter
Per the notification 29/Misc/03/2020-DC(177) dated 12.07.2021, the Intracardiac Oximeter is classified as a Class B device.
| Risk Class | Regulatory Authority | License Type | Application Form | Typical Timeline | Fee Structure |
|---|---|---|---|---|---|
| Class B | State Licensing Authority | MD5 | MD3 | 3-4 months | Rs 5,000 + Rs 500 per product |
Class B devices require a test license first, followed by product testing, documentation, audit, and license issuance.
Manufacturing License Process for Intracardiac Oximeter (MD5 License)
The manufacturing license process for a Class B device like the Intracardiac Oximeter involves multiple key stages:
Apply for Test License (Form MD13): The first step is obtaining a test license, which allows you to legally test your device in India. This process typically takes 1.5 to 2 months.
Product Testing: Conduct testing at CDSCO-approved labs. Testing validates the device’s safety and performance parameters. You can check the list of CDSCO-approved Testing Laboratories to select a suitable lab.
Documentation Preparation: Compile essential documents such as Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Application for Manufacturing License (Form MD3): Submit your application through the CDSCO MD Online Portal. Ensure all required documents and fees are included.
Audit by Notified Body: The manufacturing site will undergo an audit by a notified body. Refer to the Notified Bodies List for authorized auditors.
Query Resolution: Address any queries raised by the CDSCO or the notified body promptly to avoid delays.
License Grant (Form MD5): Upon satisfactory compliance, the State Licensing Authority will issue the MD5 manufacturing license.
Manufacturing License Documents Required for Intracardiac Oximeter
To ensure your application is robust, prepare the following documents:
- Company Constitution and Incorporation Certificate
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) detailing device specifications, design, manufacturing process, and validation (learn more here)
- Plant Master File (PMF) describing manufacturing infrastructure and quality systems (guide available here)
- Essential Principles Compliance Checklist
- Risk Management File (best practices here)
- Test Reports from government-approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485 certified
Import License Process for Intracardiac Oximeter (MD15 License)
For importers intending to bring the Intracardiac Oximeter into India, an MD15 import license from the Central Licensing Authority is mandatory. The process includes:
- Preparation of requisite documents
- Submission of application via the CDSCO MD Online Portal
- Resolution of any queries
- License grant within 5-6 months
Unlike manufacturing licenses, no test license is required for imports.
Import License Documents Required
Import license applications must include:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license for distribution in India
- Company constitution and ownership proof
Timeline and Processing Duration
| Process Stage | Typical Duration |
|---|---|
| Test License (MD13) | 1.5 to 2 months |
| Product Testing | 1 to 1.5 months |
| Document Preparation | Variable (2-4 weeks) |
| MD5 License Application | 1 month (including audit) |
| Total Time for MD5 License | Approx. 3 to 4 months |
| MD15 Import License | Approx. 5 to 6 months |
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B Device) | Rs 5,000 | Rs 500 |
| MD15 Import License (Class B) | $2,000 (approx Rs 1,60,000) | $1,000 (approx Rs 80,000) |
Note: Fees are subject to change; always verify on the official CDSCO portal.
Common Challenges and Solutions
Challenge 1: Delays in Test License and Product Testing
- Solution: Initiate the test license application early and select testing labs well in advance. Coordinate closely with labs to prioritize testing.
Challenge 2: Documentation Gaps Leading to Query Backlogs
- Solution: Use detailed checklists and templates for Device and Plant Master Files. Engage experienced consultants to ensure completeness.
Challenge 3: Notified Body Audit Non-Compliance
- Solution: Conduct internal pre-audits and staff training to align with audit requirements.
Challenge 4: Misclassification of Device Risk Class
- Solution: Refer to the official Medical Device Classification guide to confirm your device class before application.
Expert Consultation and Support
Navigating CDSCO licensing can be complex. Our proven expertise, having assisted over 500 clients, ensures your application is flawless, timely, and compliant. We offer:
- Gap analysis of your dossier
- Preparation of DMF, PMF, and Risk Management files
- Liaison with notified bodies and labs
- End-to-end project management from test license to final approval
Getting Started with Your CDSCO License Application
- Assess your device classification and regulatory requirements. Confirm that Intracardiac Oximeter is Class B.
- Prepare your technical files and QMS documentation. Utilize templates and expert guidance.
- Apply for the Test License (MD13) immediately through the CDSCO MD Online Portal.
- Schedule product testing at a CDSCO-approved lab early to avoid bottlenecks.
- Simultaneously prepare your application for the MD5 manufacturing license (Form MD3).
- Engage a notified body for pre-audit readiness and formal audit.
- Respond promptly to any regulatory queries to prevent delays.
By following these steps and leveraging our expertise, your Intracardiac Oximeter will be on the path to successful approval and market entry in India.
For personalized assistance, documentation support, and application handling, contact us today and ensure your CDSCO licensing journey is smooth and efficient.
