CDSCO License for Oximetry catheters, Oximetry Paceport catheter
Medical Device Information
Intended Use
It is indicated for the assessment of a patient’s hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions
Comprehensive Guide to CDSCO Licensing for Oximetry Catheters (Class B Medical Devices)
Oximetry catheters, including the specialized Oximetry Paceport catheter, play a critical role in cardiac care by enabling precise hemodynamic monitoring and infusion capabilities. These devices are vital for assessing intracardiac and pulmonary artery pressures, cardiac output, and continuous venous oxygen saturation, making them indispensable in intensive care and cardiology settings.
Given their clinical importance and invasive use, these catheters fall under Class B risk classification as per the Central Drugs Standard Control Organization (CDSCO) regulations in India. Understanding and navigating the CDSCO regulatory framework is essential for manufacturers and importers aiming to market these devices in India.
CDSCO Regulatory Framework for Oximetry Catheters
The CDSCO classifies medical devices into four risk classes: A, B, C, and D. Oximetry catheters are categorized as Class B, meaning they pose a moderate risk to patients and therefore require a State Licensing Authority issued MD5 license. This involves compliance with stringent quality, safety, and performance standards.
The relevant CDSCO notification governing these devices is 29/Misc/3/2017-DC (292) dated 06.06.2018, which provides the legal basis for regulatory requirements. Compliance ensures not only market authorization but also builds confidence with healthcare providers and patients.
Risk Classification and License Requirements for Oximetry Catheters
| Device Type | Risk Class | License Type | Licensing Authority | Approximate Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Oximetry Catheters | B | MD5 | State Licensing Authority | 3-4 months | ₹5,000 (application) + ₹500/product |
As a Class B device, an MD5 Manufacturing License is mandatory for local manufacturers, and importers need to comply with MD15 import licensing.
Manufacturing License Process (MD5) for Oximetry Catheters
The MD5 license process for Class B devices like Oximetry catheters involves the following sequential steps:
- Test License (MD13) Application: This initial step allows for sample testing and takes about 1.5-2 months.
- Product Testing: Conducted at CDSCO-approved government labs; critical to demonstrate conformity with Indian standards.
- Document Preparation: Comprehensive dossier including technical and quality documents.
- MD5 License Application (Form MD3): Submitted via the CDSCO MD Online Portal.
- Audit by Notified Body: A mandatory onsite audit confirming compliance with Good Manufacturing Practices (GMP).
- Query Resolution: Addressing any observations raised by the CDSCO or notified body.
- Grant of License (Form MD5): Final issuance enabling manufacturing within India.
Manufacturing License Documents Required for Oximetry Catheters
To ensure a smooth application, prepare the following documents meticulously:
- Company Constitution Documents (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualification and Experience Certificates
- Fire NOC and Pollution Control NOC
- Device Master File (DMF): Detailing design, manufacturing process, and product specifications. Our detailed Device Master File guide can assist in preparation.
- Plant Master File (PMF): Documentation of manufacturing site infrastructure and capabilities. Learn how to prepare an effective PMF here.
- Essential Principles Checklist: Demonstrating compliance with Indian Essential Principles for medical devices.
- Risk Management File: Including hazard analysis and mitigation plans, critical for patient safety. Refer to our risk management resource.
- Test Reports: From CDSCO-approved testing labs, verifying product safety and performance.
- Labels and Instructions for Use (IFU): In accordance with CDSCO labeling requirements.
- Quality Management System (QMS) Documentation: Typically ISO 13485:2016 certification and associated procedures.
Import License Process (MD15) for Oximetry Catheters
For importers, the process differs slightly and is managed by the Central Licensing Authority with a longer timeline:
- No Test License required.
- Document Preparation: Including existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files.
- Application Submission: Using Form MD14 on the CDSCO MD Online Portal.
- Queries Resolution: As raised by CDSCO during review.
- License Grant (Form MD15): Typically takes 5-6 months.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate or equivalent international approvals
- Device Master File and Plant Master File
- Wholesale License
- Company Constitution Documents
Timeline and Processing Duration
| License Type | Process Duration |
|---|---|
| MD5 Manufacturing | 3-4 months (including test license and audit) |
| MD15 Import | 5-6 months |
The test license phase (MD13) for manufacturing is critical and can take 1.5-2 months alone. Early preparation of documents and proactive query management can significantly reduce delays.
Government Fees and Costs
- MD5 License: ₹5,000 per application + ₹500 per product
- MD9 License (for higher classes): ₹50,000 + ₹1,000 per product (not applicable here)
- MD15 Import License Fees: Varies by class; for Class B devices, fees are higher but specific to importers.
Budgeting for these fees, along with costs for audits, testing, and consultancy, is essential to avoid surprises.
Common Challenges and Solutions
- Delays in Test Reports: Coordinate early with CDSCO-approved testing laboratories to schedule tests and avoid bottlenecks.
- Incomplete Documentation: Use detailed checklists and expert reviews to ensure all required files, such as DMF and PMF, meet CDSCO standards.
- Audit Non-compliance: Engage experienced notified bodies from the official list familiar with catheter manufacturing audits.
- Regulatory Queries: Maintain prompt and clear communication with CDSCO officials to resolve queries quickly.
Expert Consultation and Support
With over 25 years of experience assisting 500+ companies, we understand the nuances of securing CDSCO licenses for Class B devices like Oximetry catheters. Our tailored consulting services cover:
- Regulatory strategy and compliance gap analysis
- Complete dossier preparation and review
- Coordination with notified bodies and testing labs
- Audit readiness and post-audit support
- License application submission and follow-up
Our holistic approach reduces timelines and enhances your chance of first-time approval.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your Oximetry catheter is Class B using resources like our Medical Device Classification guide.
- Initiate Test License Application: Prepare and submit Form MD13 via the CDSCO MD Online Portal.
- Engage Testing Laboratories: Schedule product testing at approved labs to avoid delays.
- Compile Technical Documentation: Begin assembling DMF, PMF, risk management files, and QMS evidence.
- Select and Coordinate with a Notified Body: Ensure readiness for the manufacturing site audit.
- Submit MD5 License Application: Use Form MD3 on the CDSCO portal once testing and documentation are complete.
By adhering to these steps and leveraging expert support, manufacturers and importers can confidently navigate the CDSCO licensing process for Oximetry catheters, ensuring timely and compliant market entry in India.
