CDSCO License for Oesophageal temperature monitor

Comprehensive Guide to CDSCO Licensing for Oesophageal Temperature Monitor (Class B Medical Device)

As a trusted regulatory consultancy with over 25 years of experience assisting 500+ companies successfully navigate CDSCO licensing, we understand the critical importance of obtaining timely and compliant approval for medical devices in India. The Oesophageal Temperature Monitor, classified as a Class B device under CDSCO guidelines, plays an essential role in gastroenterology by ensuring patient safety during delicate cardiac ablation procedures. This detailed guide provides manufacturers and importers with practical, actionable insights on securing the necessary CDSCO license, including timelines, costs, documentation, and common challenges.

Understanding the Oesophageal Temperature Monitor and Regulatory Significance

The Oesophageal Temperature Monitor is an electronic medical device designed to measure the temperature inside the oesophagus at multiple adjacent levels during surgical ablation of the left atrium's wall. Its primary role is to assist surgeons in preventing thermal injury that could lead to atrial-oesophageal fistulas, a serious complication.

Given its direct involvement in invasive procedures and patient safety implications, the device is classified as Class B (low-moderate risk) under the CDSCO Medical Device Classification. Proper regulatory compliance is mandatory before manufacturing or importing this device for the Indian market.

CDSCO Regulatory Framework for Class B Medical Devices

India’s Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules (MDR) 2017. Class B devices require a manufacturing license from the State Licensing Authority under Form MD5 (application form MD3) and adherence to quality assurance, safety, and efficacy standards.

For the Oesophageal Temperature Monitor:

• Risk Class: B (Low moderate risk)
• Regulatory Pathway: MD5 License for manufacturing
• Governing Authority: State Licensing Authority
• Notification Reference: 29/Misc./03/2020-DC (182) dated 27.09.2021

Risk Classification and License Requirements

The classification as Class B means that the device is subject to moderate regulatory controls, including:

• Obtaining a Test License on Form MD13 prior to manufacturing
• Submission of comprehensive technical documentation such as Device Master File and Plant Master File
• Product testing at government-approved laboratories
• Audit by a Notified Body as per CDSCO guidelines

Manufacturers must comply with these to obtain the MD5 license.

Manufacturing License Process for Oesophageal Temperature Monitor (MD5 License)

The manufacturing license process for a Class B device like the Oesophageal Temperature Monitor involves several key steps:

1. Apply for Test License (Form MD13): Submit application via the CDSCO MD Online Portal. This license permits initial testing and validation.
2. Product Testing: Get the device tested at one of the CDSCO-approved Testing Laboratories. Testing typically covers electrical safety, biocompatibility, and performance parameters.
3. Document Preparation: Prepare regulatory documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and others.
4. Apply for Manufacturing License (Form MD3 for MD5 License): Submit detailed application on the CDSCO portal.
5. Audit by Notified Body: A notified body from the CDSCO Notified Bodies List conducts a thorough inspection of manufacturing facilities and quality systems.
6. Query Resolution: Address any observations or queries from the CDSCO or notified body promptly.
7. Grant of MD5 License (Form MD5): Upon satisfactory compliance, the state authority issues the manufacturing license.

Manufacturing License Documents Required

For the Oesophageal Temperature Monitor, the following documents are mandatory:

• Company Constitution (Incorporation Certificate, MOA/AOA)
• Proof of ownership or lease agreement of manufacturing premises
• Technical staff qualification and experience details
• Fire No Objection Certificate (NOC)
• Pollution Control Board NOC
• Device Master File (DMF): Detailed device description, design, manufacturing process (Guide here)
• Plant Master File (PMF): Description of manufacturing facilities and quality control processes (Guide here)
• Essential Principles Checklist confirming compliance with Indian standards
• Risk Management File demonstrating hazard analysis and mitigation (Learn more)
• Test Reports from government-approved labs
• Device Labels and Instructions for Use (IFU)
• Quality Management System (QMS) documents, preferably ISO 13485 compliant

Import License Process for Oesophageal Temperature Monitor (MD15 License)

If you are an importer rather than a manufacturer, the process differs slightly. The MD15 import license is granted by the Central Licensing Authority and includes:

• Preparation of import-specific documentation such as Free Sale Certificate, CE Certificate, Manufacturing License from country of origin
• Submission of application on Form MD14 via the CDSCO portal
• Queries resolution and compliance verification

The entire import license process typically takes 5-6 months.

Import License Documents Required

Key documents required for import license application include:

• Manufacturing License of the foreign manufacturer
• Free Sale Certificate or Certificate of Market Authorization
• ISO 13485:2016 certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution

Timeline and Processing Duration

For import license (MD15), the process ranges from 5 to 6 months.

Government Fees and Costs

For the Oesophageal Temperature Monitor (Class B device):

• MD5 License Fee: Rs 5,000 per application
• Per Product Fee: Rs 500

Additional costs include testing fees at government-approved labs and audit fees charged by notified bodies.

Common Challenges and Practical Solutions

Challenge 1: Delays in product testing due to backlog at approved labs.

• Solution: Schedule testing early during the test license period and consider multiple approved labs.

Challenge 2: Incomplete or inconsistent documentation.

• Solution: Rely on expert preparation of Device Master File and Plant Master File as per CDSCO standards.

Challenge 3: Audit non-conformities.

• Solution: Conduct pre-audit internal assessments and ensure ISO 13485 QMS implementation.

Challenge 4: Query resolution delays.

• Solution: Maintain prompt communication with CDSCO and prepare detailed responses with supporting evidence.

Expert Consultation and Support

Navigating the CDSCO licensing process for an Oesophageal Temperature Monitor can be complex. Our team, having facilitated over 500 successful approvals, offers end-to-end support including document preparation, test license acquisition, audit coordination, and query management. We keep abreast of evolving regulations and provide tailored strategies to expedite approvals.

Getting Started with Your CDSCO License Application

1. Classify your device: Confirm Class B status and review relevant notifications (29/Misc./03/2020-DC (182) dated 27.09.2021).
2. Register on the CDSCO MD Online Portal: Begin by creating your account at the CDSCO MD Online Portal.
3. Apply for Test License (Form MD13): Initiate the process by securing the test license allowing product testing.
4. Engage an approved testing laboratory: Schedule testing early to avoid delays.
5. Prepare robust device and plant master files: Refer to our detailed Device Master File guide and Plant Master File guide.
6. Coordinate with a notified body: Select from the list of notified bodies for your audit.
7. Submit manufacturing license application (Form MD3): Upload all documents and await audit scheduling.
8. Respond to queries promptly: Maintain a clear communication trail.

By following these practical steps and leveraging expert guidance, manufacturers and importers of Oesophageal Temperature Monitors can ensure a streamlined CDSCO licensing journey, minimizing time-to-market and regulatory risks.

For personalized assistance and comprehensive consulting services, reach out to our regulatory experts who specialize in Indian medical device compliance.

Empower your medical device business with trusted regulatory compliance — your pathway to success in the Indian healthcare market starts here.