CDSCO License for Gastro-oesophageal pH/impedance catheter, sterile
Medical Device Information
Intended Use
A sterile flexible tube with an with an electrical conductor at its distal end intended to be inserted through the nose into the oesophagus and stomach to measure pH and/or electrical impedance, typically for the evaluation of gastro-oesophageal reflux disease (GERD), gastric ulcers, or other gastrointestinal conditions.
Comprehensive Guide to CDSCO Licensing for Gastro-oesophageal pH/Impedance Catheters (Sterile)
Entering the Indian medical device market with a Gastro-oesophageal pH/impedance catheter (sterile) requires navigating the CDSCO regulatory framework efficiently. This device, classified as Class B due to its moderate risk profile, plays a vital role in diagnosing gastrointestinal conditions such as GERD and gastric ulcers by measuring pH and electrical impedance within the oesophagus and stomach. With over 25 years of experience and having assisted more than 500 companies, we provide you with a detailed roadmap to secure your CDSCO license seamlessly.
CDSCO Regulatory Framework for Gastroenterology Devices
The Central Drugs Standard Control Organization (CDSCO) governs the approval of medical devices in India under the Medical Device Rules, 2017. The Gastro-oesophageal pH/impedance catheter, being a Class B device, falls under the purview of the State Licensing Authority for manufacturing licenses and Central Licensing Authority for import licenses.
Understanding the regulatory landscape is crucial to ensure compliance with the Notification 29/Misc./03/2020-DC (182), dated 27.09.2021, which specifically includes this device under gastroenterology category.
Risk Classification and License Requirements for Class B Devices
Class B devices are considered low to moderate risk. For such devices, manufacturers must obtain an MD5 license (Manufacturing License for Class A and B devices) from the State Licensing Authority. Importers require an MD15 license from the Central Licensing Authority.
- Manufacturing License: MD5 (Application Form MD3)
- Import License: MD15 (Application Form MD14)
For more on device classification, refer to our detailed Medical Device Classification guide.
Manufacturing License Process (MD5) for Sterile Gastro-oesophageal pH/Impedance Catheters
The MD5 license process involves several critical steps:
Apply for Test License (Form MD13): Before full manufacturing license application, obtain a test license to start limited production for testing. This process takes approximately 1.5 to 2 months.
Product Testing: Send your catheter samples to government-approved testing laboratories listed on the CDSCO Testing Laboratories portal to validate compliance with essential standards.
Documentation Preparation: Compile detailed technical documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.
Submit Manufacturing License Application (Form MD3): File your application via the CDSCO MD Online Portal with all supporting documents.
Audit by Notified Body: A notified body from the official Notified Bodies List will conduct a thorough audit of your manufacturing facility and quality systems.
Respond to Queries: Address any observations or queries raised by CDSCO or the notified body promptly.
Grant of MD5 License: Upon satisfactory review and audit, the license is granted on Form MD5.
This entire process typically spans 3 to 4 months.
Manufacturing License Documents Required
To ensure a smooth application, 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 Board NOC
- Device Master File outlining device specifications and manufacturing processes (Device Master File Guide)
- Plant Master File detailing manufacturing site and equipment (Plant Master File Guide)
- Essential Principles Checklist ensuring compliance with safety and performance requirements
- Risk Management File demonstrating hazard identification and mitigation (Risk Management Resource)
- Test Reports from accredited laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 compliant)
Import License Process (MD15) for Gastro-oesophageal pH/Impedance Catheters
For importers of this Class B device, the MD15 license is mandatory. The process includes:
Documentation Preparation: Compile all required certificates including Manufacturing License, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and Company Constitution.
Application Submission: Apply on the CDSCO MD Online Portal using Form MD14.
Query Resolution: Respond to any CDSCO queries timely.
License Grant: Approval typically takes 5 to 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
- Device Master File and Plant Master File
- Wholesale License for distribution
- Company Constitution and address proof
Timeline and Processing Duration
| License Type | Key Steps | Duration |
|---|---|---|
| Test License (MD13) | Application, Testing, Approval | 1.5 – 2 months |
| Manufacturing (MD5) | Document prep, Testing, Audit | 3 – 4 months total |
| Import License (MD15) | Document prep, Review, Approval | 5 – 6 months |
Government Fees and Costs
MD5 License:
- Rs 5,000 per application
- Rs 500 per product
MD15 Import License:
- Class B devices: Rs 1,50,000 per site
- Rs 50,000 per product
Additional costs include testing fees at government-approved labs and notified body audit charges.
Common Challenges and Solutions
- Delays in Testing: Testing laboratories can have backlogs; plan sample submissions early.
- Incomplete Documentation: Missing or inconsistent documents cause review delays; use checklists and expert consultation.
- Audit Readiness: Ensure your Quality Management System and facility comply fully before audit to avoid non-conformities.
- Query Management: Respond promptly and comprehensively to CDSCO queries to prevent prolonged processing.
Expert Consultation and Support
Navigating CDSCO licensing for a specialized device like a sterile Gastro-oesophageal pH/impedance catheter requires careful planning. Our regulatory experts provide tailored support including documentation review, audit preparedness, and liaison with CDSCO authorities, ensuring a hassle-free approval process.
Explore our detailed guides: MD5 License Guide, Import License Guide.
Getting Started with Your CDSCO License Application
- Assess your device classification carefully to confirm the need for an MD5 license.
- Initiate the test license application (Form MD13) via the CDSCO MD Online Portal.
- Engage with accredited testing labs early to schedule sample testing.
- Prepare comprehensive documentation — leverage our Device and Plant Master File guides.
- Identify and coordinate with a notified body for the mandatory audit.
- Plan timelines realistically considering possible queries and audit dates.
- Consult regulatory experts to review your application package before submission.
By following these practical steps and leveraging our extensive regulatory expertise, you can confidently bring your sterile Gastro-oesophageal pH/impedance catheter to the Indian market, ensuring compliance, safety, and timely market access.
