CDSCO License for Intestinal ostomy kit
Medical Device Information
Important Notice for Class A Devices
Class A Non-sterile Non Measuring devices are exempt from MD5 and MD15 licenses. Only CDSCO registration is required as per GSR 777(E).
Intended Use
A collection of non-sterile devices intended to be used for attachment/replacement of an intestinal ostomy bag (for collecting intestinal output such as faeces following a colostomy or ileostomy procedure).
Comprehensive Guide to CDSCO Licensing for Intestinal Ostomy Kits (Class A Medical Device)
As specialists with over 25 years of experience in navigating the Indian medical device regulatory landscape, we have supported more than 500 manufacturers and importers in successfully obtaining CDSCO licenses. If you are manufacturing or importing an Intestinal Ostomy Kit—a Class A gastroenterology device designed for attachment or replacement of intestinal ostomy bags—this guide will walk you through the entire CDSCO licensing process, timeline, costs, and documentation requirements.
Understanding the Intestinal Ostomy Kit and Regulatory Importance
An Intestinal Ostomy Kit comprises multiple non-sterile components used post-colostomy or ileostomy to collect intestinal output such as feces. Given its direct patient interface, even as a Class A device under India's medical device rules, regulatory compliance is essential to ensure product safety, quality, and market access.
The device is notified under Reference 29/Misc./03/2020-DC (182) dated 27.09.2021, classified as Class A (low risk) per the CDSCO classification system.
CDSCO Regulatory Framework for Intestinal Ostomy Kits
In India, medical devices are regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Ministry of Health & Family Welfare. Class A devices require a manufacturing license issued by the State Licensing Authority via the MD5 license process.
Manufacturers must first obtain a Test License (Form MD13) to perform product testing at government-approved labs, followed by the submission of a complete application on the CDSCO MD Online Portal.
Risk Classification and License Requirements
- Device Risk Class: A (Low risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Issuing Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months total
For detailed classification insights, refer to our Medical Device Classification Guide.
Manufacturing License Process (MD5)
Apply for Test License (Form MD13): Submit application for test license through the CDSCO MD Online Portal. The test license is valid for 6 months and takes about 1.5–2 months for approval.
Product Testing: Conduct mandatory product testing at CDSCO-approved laboratories. A list of testing laboratories is available online.
Compile Documentation: Prepare comprehensive documentation including your Device Master File (DMF), Plant Master File (PMF), Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documents.
Submit Manufacturing License Application (Form MD3): File your application along with all required documents on the CDSCO portal.
Notified Body Audit: Arrange audit by a notified body from the official Notified Bodies List. This audit covers your manufacturing premises, processes, and QMS.
Respond to Queries: Address any queries or observations raised by CDSCO or the notified body promptly to avoid delays.
License Grant: Upon successful audit and document verification, the MD5 license is granted on Form MD5.
For an in-depth walkthrough, consult our MD5 License Guide.
Manufacturing License Documents Required
- Company Constitution (MoA, AoA)
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience certificates of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF) detailing design, components, and manufacturing process (DMF Guide)
- Plant Master File (PMF) describing manufacturing facility and operations (PMF Guide)
- Essential Principles Checklist aligned with Indian regulations
- Risk Management File based on ISO 14971 principles (Risk Management Guide)
- Test reports from CDSCO-approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System documents (ISO 13485:2016 certification recommended)
Import License Process (MD15)
While your intestinal ostomy kit falls under Class A and primarily involves manufacturing licensing, importers seeking to bring this device into India must apply for an MD15 import license granted by the Central Licensing Authority.
Key steps include:
- Document preparation including Manufacturing License, Free Sale Certificate, ISO 13485, CE Certificate
- Submission of application on CDSCO MD Online Portal
- Resolution of queries raised by CDSCO
- License grant typically within 5-6 months
Learn more with our detailed Import License Guide.
Timeline and Processing Duration
| Step | Duration |
|---|---|
| Test License Approval | 1.5 – 2 months |
| Product Testing | 2 – 3 weeks |
| Documentation Prep | Variable (2–4 weeks) |
| Audit by Notified Body | 2 – 4 weeks |
| CDSCO Review & Grant | 3 – 4 weeks |
Total estimated time: Approximately 3 to 4 months from test license application to MD5 license issuance.
Government Fees and Costs
- Application fee: INR 5,000 per application
- Product fee: INR 500 per product (per device variant)
- Additional costs:
- Testing laboratory fees (varies by lab and tests required)
- Notified body audit fees (varies by auditor)
- Consultancy and documentation preparation (if outsourced)
Budgeting for these fees upfront can prevent unexpected delays.
Common Challenges and Practical Solutions
Incomplete Documentation: Missing or inconsistent documents are the leading cause of delays. Ensure full compliance by cross-checking each document per CDSCO requirements.
Test Report Rejections: Select CDSCO-approved labs listed on the official portal and confirm test scopes beforehand.
Audit Non-conformities: Prepare the facility and QMS rigorously before the notified body audit. Mock audits can help identify gaps early.
Delayed Query Responses: Assign a dedicated regulatory liaison to respond swiftly to CDSCO and auditor queries.
Expert Consultation and Support
With our extensive experience across diverse medical device categories including gastroenterology products like Intestinal Ostomy Kits, we provide end-to-end CDSCO licensing support. From test license procurement to audit readiness and post-license compliance, our tailored solutions help you navigate complex regulatory hurdles efficiently.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm the Class A classification applies to your intestinal ostomy kit.
Gather Preliminary Documents: Begin compiling company constitution, facility ownership proof, and technical staff credentials.
Initiate Test License Application: Register and submit the Form MD13 on the CDSCO MD Online Portal.
Plan Product Testing: Identify suitable CDSCO-approved labs early to schedule timely testing.
Prepare Device & Plant Master Files: Develop comprehensive, regulatory-compliant DMF and PMF per our guides.
Engage a Notified Body: Schedule your audit to align with document readiness.
Submit MD5 Application: Compile and submit your Form MD3 application with all requisite documents.
Monitor Application Status & Respond Promptly: Use the CDSCO portal dashboard to track progress and address queries.
Taking these proactive steps will position your intestinal ostomy kit for a smooth and timely CDSCO license approval, enabling you to confidently enter the Indian medical device market.
For personalized assistance and detailed consultation, feel free to reach out to our regulatory experts who have successfully facilitated over 500 CDSCO licensing projects.
