CDSCO License for Intestinal stoma shield/support belt, single- use
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 non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin.
Introduction to Intestinal Stoma Shield/Support Belt and Regulatory Importance
The intestinal stoma shield/support belt (single-use) is a Class A medical device designed to protect enteric stomas by shielding them from external trauma, reducing herniation risks, and enhancing adhesion of the base plate to the skin. As a non-sterile device used in gastroenterology, obtaining proper regulatory approval from the Central Drugs Standard Control Organization (CDSCO) is critical to legally manufacture or import this product in India. Compliance ensures patient safety, market access, and builds trust with healthcare professionals.
With over 25 years of experience assisting 500+ medical device manufacturers and importers, we provide detailed guidance on navigating the CDSCO licensing process specifically for this device type.
CDSCO Regulatory Framework for Intestinal Stoma Shield/Support Belt
Intestinal stoma shields fall under the CDSCO's medical device regulations governed by the Medical Device Rules, 2017. The device is categorized under gastroenterology and notified through Notification No. 29/Misc./03/2020-DC (182), dated 27.09.2021. Regulatory oversight is primarily through the State Licensing Authority for Class A devices.
Risk Classification and License Requirements for Class A Devices
Class A devices represent low-risk medical devices. For intestinal stoma shields, this classification means the manufacturing license is granted by the State Licensing Authority via the MD5 license (Form MD3 application). The process includes obtaining a test license, product testing, audit by a notified body, and final licensing.
For a comprehensive understanding of medical device classification, refer to our detailed Medical Device Classification guide.
Manufacturing License Process for Intestinal Stoma Shield (MD5 License)
The manufacturing license process for Class A devices like the intestinal stoma shield involves several sequential steps:
Test License (Form MD13): Initially, apply for the test license to allow product testing. This phase takes approximately 1.5 to 2 months.
Product Testing: Testing must be conducted at government-approved laboratories listed on the CDSCO Testing Laboratories page. Testing verifies product safety and conformity to standards.
Document Preparation: Compile all required documentation including Device Master File and Plant Master File.
License Application (Form MD3): Apply for the MD5 manufacturing license through the CDSCO MD Online Portal.
Audit by Notified Body: A notified body conducts an audit of the manufacturing facility and quality systems. Refer to the List of Notified Bodies for authorized auditors.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly.
Grant of License (Form MD5): Upon satisfactory completion, the license is granted.
The entire process typically takes 3 to 4 months.
For a detailed walkthrough, consult our MD5 License Guide.
Manufacturing License Documents Required
Manufacturers of intestinal stoma shields must prepare and submit the following documents:
- Company Constitution (e.g., Certificate of Incorporation)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Technical Staff qualified for device manufacturing
- Fire NOC and Pollution Control NOC from relevant authorities
- Device Master File (DMF) detailing device specifications, design, and manufacturing processes. Our Device Master File guide offers a comprehensive framework.
- Plant Master File (PMF) describing the manufacturing site and quality management systems. Learn more from our Plant Master File guide.
- Essential Principles Checklist ensuring compliance with safety and performance requirements
- Risk Management File documenting hazard identification and mitigation strategies. See our Risk Management guide.
- Test Reports from approved laboratories
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as ISO 13485 certification
Import License Process (MD15 License) for Intestinal Stoma Shield
For importers, the MD15 license is mandatory, granted by the Central Licensing Authority. The process differs from manufacturing licensing:
- No Test License Required
- Document Preparation including Manufacturing License from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate
- Application Submission (Form MD14) through the CDSCO MD Online Portal
- Query Resolution post department review
- License Grant (Form MD15)
The import license process usually spans 5 to 6 months.
For more detailed guidance, see our Import License Guide.
Import License Documents Required
Importers must submit:
- Valid Manufacturing License from the exporting country
- Free Sale Certificate
- ISO 13485:2016 Certificate
- CE Certificate or equivalent
- Device Master File
- Plant Master File
- Wholesale License for distribution
- Company Constitution
Timeline and Processing Duration
| License Type | Process Steps | Typical Duration |
|---|---|---|
| MD5 (Manufacturing) | Test License → Testing → Audit → License | 3 to 4 months |
| MD15 (Import) | Document preparation → Application → License | 5 to 6 months |
Early preparation of documents and proactive query resolution can reduce delays significantly.
Government Fees and Costs
MD5 License (Manufacturing Class A devices):
- Application Fee: Rs 5,000 per application
- Product Fee: Rs 500 per product
MD15 License (Import Class A devices):
- Site Fee: Approx. $1,000 per site
- Product Fee: Approx. $50 per product
Additional costs include testing fees at approved labs and audit charges by notified bodies.
Common Challenges and Solutions
Delayed Testing Reports: Schedule testing early and select government-approved labs with known turnaround times.
Incomplete Documentation: Use detailed checklists like Device Master File and Plant Master File templates to ensure completeness.
Audit Non-Compliance: Prepare your QMS and facility rigorously to meet notified body standards.
Query Delays: Respond promptly and comprehensively to departmental queries to avoid processing bottlenecks.
Our hands-on experience means we have helped manufacturers avoid these pitfalls effectively.
Expert Consultation and Support
Navigating CDSCO licensing for intestinal stoma shields can be complex. Our expert consultants offer:
- Customized document preparation
- Compliance gap assessments
- Coordination with notified bodies and laboratories
- End-to-end application tracking
Rely on our 25+ years of expertise to streamline your licensing journey.
Getting Started with Your CDSCO License Application
Assess Your Device Classification: Confirm Class A status and applicability of MD5 licensing.
Register on the CDSCO MD Online Portal: Create your company profile and submit initial requests.
Apply for the Test License (MD13): This is crucial before manufacturing or product testing.
Identify Approved Testing Laboratories: Choose labs from the official Testing Laboratories list.
Prepare Required Documentation: Utilize available guides for Device Master File and Plant Master File to avoid errors.
Schedule Notified Body Audit: Engage early to align audit timelines with application submission.
Submit Application and Track Progress: Use the CDSCO MD Online Portal dashboard for status updates.
Starting your licensing process with a clear roadmap and professional support ensures timely market entry for your intestinal stoma shield. Contact us today to leverage our proven expertise in CDSCO medical device licensing.
