CDSCO License for Gastrointestinal manometric catheter, electronic
Medical Device Information
Intended Use
A non-sterile flexible tube with electronic sensors at the distal end intended to be inserted through the nose or rectum into the gastrointestinal (GI) tract to evaluate peristaltic motility anywhere in the GI tract (pharynx, oesophagus, stomach, duodenum, small bowel, colon, and anorectal area) by measuring pressure; it may additionally be intended to measure pH and electrical impedance and contain a lumen.
Comprehensive Guide to CDSCO Licensing for Electronic Gastrointestinal Manometric Catheters (Class B)
Entering the Indian medical device market with advanced gastroenterology products like the electronic gastrointestinal manometric catheter requires a clear understanding of the regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO). This device, classified as Class B under Indian regulations, plays a vital role in diagnosing motility disorders by measuring pressures within the GI tract via electronic sensors. Compliance with CDSCO licensing is not just a regulatory formality; it ensures your product meets stringent safety and quality standards, enabling trust among healthcare providers and patients alike.
CDSCO Regulatory Framework for Gastrointestinal Manometric Catheters
The CDSCO framework categorizes medical devices based on risk, intended use, and complexity. Your electronic gastrointestinal manometric catheter falls under Class B due to its moderate risk profile, involving electronic sensors inserted into sensitive anatomical sites. This classification mandates obtaining a manufacturing license known as the MD5 license, issued by the State Licensing Authority, before commercial distribution in India.
To streamline your application, it is crucial to submit all documents through the CDSCO MD Online Portal, which centralizes the entire process and offers transparent status tracking.
Risk Classification and License Requirements
- Device: Electronic Gastrointestinal Manometric Catheter
- Risk Class: B (Moderate risk)
- License Type: MD5 (Manufacturing License for Class A & B)
- Authority: State Licensing Authority
- Regulatory Notification: 29/Misc./03/2020-DC (182) dated 27.09.2021
Class B devices require manufacturers to first obtain a Test License (Form MD13), undergo product testing at government-approved laboratories, and subsequently apply for the full manufacturing license (Form MD3).
Manufacturing License Process (MD5)
The MD5 license process for your device includes several well-defined steps:
Test License Application (Form MD13): Submit an application to the State Licensing Authority to manufacture the device for test purposes. This stage typically takes 1.5 to 2 months.
Product Testing: Conduct mandatory testing at CDSCO-recognized laboratories to validate safety and performance parameters. You can find an updated list of testing laboratories here.
Document Preparation: Compile essential documents, including technical files, quality management system (QMS) details, and risk assessments.
Manufacturing License Application (Form MD3): Submit the final application for the MD5 license.
Audit by Notified Body: An authorized notified body will conduct an on-site audit of your manufacturing facility. For audit requirements and notified bodies, refer to the notified bodies list.
Queries Resolution: Address any observations or queries raised by the authority or auditor promptly.
Grant of MD5 License (Form MD5): Upon satisfactory compliance, the license is granted.
Overall, the entire licensing cycle averages 3 to 4 months, depending on the promptness of testing and audit scheduling.
Manufacturing License Documents Required
Ensuring comprehensive and accurate documentation is key to avoid delays. For your electronic gastrointestinal manometric catheter, prepare the following:
- Company Constitution & Incorporation Certificates
- Proof of Ownership or Lease of Manufacturing Premises
- Technical Staff Qualifications and Experience Details
- Fire NOC and Pollution Control NOC
- Device Master File (DMF) – including detailed product design, intended use, specifications, and risk management plans. Our detailed Device Master File Guide can help streamline this.
- Plant Master File (PMF) – covering facility layout, equipment, and quality controls. For PMF preparation, see our Plant Master File Guide.
- Essential Principles Checklist confirming compliance with Indian and international standards
- Risk Management File documenting hazard analyses and mitigation strategies, following risk management best practices
- Test Reports from CDSCO-approved labs
- Labels and Instructions For Use (IFU) compliant with CDSCO labeling regulations
- Quality Management System (QMS) Documentation such as ISO 13485 certificates and SOPs
Import License Process (MD15)
If you are an importer looking to bring the electronic gastrointestinal manometric catheter into India, you must apply for an MD15 import license from the Central Licensing Authority. The process includes:
Document Preparation including manufacturing license, free sale certificate, ISO 13485:2016 certification, CE certificate, device and plant master files, wholesale license, and company constitution.
Application Submission (Form MD14) via the CDSCO MD Online Portal.
Queries Resolution on any clarifications requested by CDSCO.
Grant of MD15 License.
The complete timeline is approximately 5 to 6 months. For detailed procedural assistance, our Import License Guide offers a step-by-step walkthrough.
Import License Documents Required
- Valid Manufacturing License from the country of origin
- Free Sale Certificate proving product approval in the export country
- Certified ISO 13485:2016 Quality Management System
- CE Certificate or equivalent international certification
- Detailed Device Master File and Plant Master File
- Wholesale Drug License or equivalent
- Company constitution and proof of business
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Manufacturing License | 3 – 4 months total |
| Import License (MD15) | 5 – 6 months |
Timelines depend heavily on the completeness of documentation and responsiveness to regulatory queries.
Government Fees and Costs
For the electronic gastrointestinal manometric catheter (Class B), expect the following fees:
- MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product
- Test License (MD13): Included in the manufacturing license process
- Import License (MD15): Approximately 1,000 per product
Additional costs include testing fees charged by laboratories and audit fees payable to notified bodies.
Common Challenges and Solutions
- Incomplete Documentation: Ensure early compilation of all required files, cross-check with CDSCO checklists, and leverage expert consultation.
- Delayed Testing: Schedule testing promptly with CDSCO-approved labs; maintain communication to avoid bottlenecks.
- Audit Non-Compliance: Conduct internal pre-audits and QMS training to prepare your team.
- Query Resolution Delays: Assign dedicated regulatory personnel to respond swiftly to CDSCO queries.
Our experience with over 500 successful CDSCO licensing projects has shown that proactive planning significantly reduces approval time.
Expert Consultation and Support
Navigating CDSCO licensing for a specialized device like the electronic gastrointestinal manometric catheter requires expert guidance. Our seasoned consultants provide:
- Comprehensive gap analysis for your documentation
- Coordination with notified bodies and testing labs
- Assistance in preparing Device and Plant Master Files
- End-to-end application submission and follow-up on the CDSCO MD Online Portal
By entrusting your project to experts, you mitigate risks, avoid costly errors, and accelerate your time to market.
Getting Started with Your CDSCO License Application
Classify Your Device Precisely: Confirm your device’s Class B status via the Medical Device Classification guide.
Prepare Your Test License Application (Form MD13): Gather technical documents and initiate submission through the CDSCO portal.
Engage a CDSCO-Approved Testing Laboratory Early: Early booking prevents delays.
Develop Complete Device and Plant Master Files: Utilize our detailed guides for best practices.
Plan for the Notified Body Audit: Schedule and prepare your facility and QMS.
Maintain Continuous Communication with Regulatory Authorities: Promptly address any queries.
Leverage Professional Regulatory Consultants: Their experience can be invaluable.
Embarking on the CDSCO licensing journey for your electronic gastrointestinal manometric catheter with structured planning and expert support will pave the way for a successful launch in the Indian market. For tailored assistance, feel free to reach out and leverage our 25+ years of regulatory expertise.
