CDSCO License for Absorbent enteric stomal dressing
Medical Device Information
Intended Use
To be placed over a continent enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained from the intestines) to protect it from harmful external influences, which includes absorbent materials intended to protect the surrounding skin from enteric fluids.
Introduction to Absorbent Enteric Stomal Dressing and Its Regulatory Importance
Absorbent enteric stomal dressings are specialized medical devices designed for gastroenterology applications. These dressings are placed over a continent enteric stoma—a surgically-created opening between the intestines and body surface—to protect the site from external contaminants and absorb enteric fluids, thereby preventing skin irritation and infection. Given the critical role they play in patient care, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is mandatory for manufacturers and importers in India.
Navigating the CDSCO licensing process for this Class B device requires a clear understanding of the regulatory framework, documentation, testing requirements, and timelines. With over 25 years of experience and having supported 500+ companies in obtaining CDSCO licenses, we provide a detailed, step-by-step guide tailored for absorbent enteric stomal dressings.
CDSCO Regulatory Framework for Absorbent Enteric Stomal Dressing
The CDSCO classifies medical devices based on risk, and absorbent enteric stomal dressings fall under Class B as per Notification 29/Misc./03/2020-DC (182), dated 27.09.2021. This classification governs the type of license required, the authority involved, and the compliance pathway.
Under the new regulatory regime, manufacturing licenses for Class B devices are issued by the State Licensing Authority through the MD5 license (Form MD3). Import licenses for this device category are handled by the Central Licensing Authority via the MD15 license.
Risk Classification and License Requirements
- Device: Absorbent Enteric Stomal Dressing
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (State Authority)
- Application Form: MD3
- Test License: MD13 (mandatory before MD5)
This classification means that the manufacturing facility must obtain an MD5 license, which involves a thorough testing procedure, document submission, and an audit by a notified body.
For detailed classification confirmation, refer to our Medical Device Classification guide.
Manufacturing License Process (MD5)
The MD5 manufacturing license process for Class B devices typically spans 3 to 4 months and consists of the following key steps:
- Test License Application (Form MD13): Submit the application for a test license which takes approximately 1.5 to 2 months to process. This license permits product testing in government-approved laboratories.
- Product Testing: Conduct mandatory tests at CDSCO-recognized labs to validate product safety and performance. A list of accredited Testing Laboratories can be consulted.
- Documentation Preparation: Compile all required documents, including Device Master File and Plant Master File.
- Submission of MD5 Application (Form MD3): Apply for the manufacturing license through the CDSCO MD Online Portal.
- Audit by Notified Body: Coordinate with a notified body for the mandatory audit. You can find the list of notified bodies here.
- Resolution of Queries: Address any queries raised by the department or notified body promptly.
- Grant of License: Upon satisfactory review and audit, receive the manufacturing license (Form MD5).
Manufacturing License Documents Required
The following documents are essential to support your MD5 license application:
- Company Constitution (e.g., partnership deed, MOA, AOA)
- Proof of ownership or lease agreement of manufacturing premises
- Qualification and experience certificates of technical staff
- Fire safety NOC
- Pollution control NOC
- Device Master File (DMF) detailing design, manufacturing, and specifications (Device Master File Guide)
- Plant Master File (PMF) describing manufacturing facilities and quality systems (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with Indian standards
- Risk Management File documenting hazard analysis and mitigation (Risk Management)
- Test Reports from government-approved laboratories
- Product labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, preferably ISO 13485:2016 certification
Ensuring comprehensive and accurate documentation significantly reduces the risk of delays.
Import License Process (MD15)
For importers of absorbent enteric stomal dressings, the CDSCO mandates an MD15 license issued by the Central Licensing Authority. This process generally takes 5 to 6 months and includes:
- Preparation and submission of application on Form MD14 via the CDSCO MD Online Portal
- Document verification and resolution of department queries
- Grant of MD15 license
Unlike manufacturing, import licensing does not require a test license but requires robust documentation.
Import License Documents Required
Key documents for MD15 license include:
- Manufacturing license issued by the country of origin
- Free Sale Certificate from the exporting country
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale license (if applicable)
- Company Constitution
Comprehensive guidance on import licensing is available in our Import License Guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Documentation Preparation | 2 – 3 weeks |
| MD5 License Application (MD3) | 1 – 2 weeks |
| Audit by Notified Body | 3 – 4 weeks |
| Query Resolution & Final Grant | 2 – 3 weeks |
Total Estimated Time: 3 to 4 months for manufacturing license
For import licenses (MD15), expect 5 to 6 months due to central authority processing.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD5 (Class B) | INR 5,000 | INR 500 |
Additional costs include testing fees at government-approved laboratories (varies by test scope) and notified body audit charges (typically INR 50,000 to 1,00,000, depending on scope).
Budgeting appropriately for these expenses avoids surprises during the licensing journey.
Common Challenges and Solutions
Challenge: Delay in test license approval.
- Solution: Submit complete and accurate MD13 application, follow up regularly through the CDSCO MD Online Portal.
Challenge: Non-conformities during audit.
- Solution: Conduct internal pre-audit checks and training; engage with notified bodies listed here for guidance.
Challenge: Incomplete documentation.
- Solution: Use our comprehensive checklists for Device Master File and Plant Master File to ensure completeness.
Challenge: Delays in product testing.
- Solution: Plan testing schedules with approved laboratories early in the process.
Expert Consultation and Support
Navigating CDSCO requirements can be complex, particularly for first-time applicants. Our team has successfully helped over 500 companies secure licenses for Class B devices like absorbent enteric stomal dressings. We offer:
- End-to-end application preparation and submission
- Gap analysis for documentation and QMS
- Coordination with notified bodies and testing labs
- Post-license compliance support
Partnering with seasoned regulatory consultants can dramatically reduce timelines and increase approval success rates.
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm your device is Class B under the latest CDSCO notification.
- Register on CDSCO MD Online Portal: Create your account to access all application forms.
- Prepare Test License Application (MD13): Gather necessary documents and submit.
- Identify Testing Laboratories: Schedule product testing early.
- Compile Device Master File and Plant Master File: Use our guides to develop these critical documents.
- Engage Notified Body: Initiate audit planning once test license and test reports are ready.
- Submit Manufacturing License Application (MD3): Once audit and testing are complete.
- Monitor Application Status: Regularly track through the online portal.
- Address Queries Promptly: Keep communication lines open with CDSCO and notified bodies.
Starting early with a clear roadmap ensures a smooth path to market entry for your absorbent enteric stomal dressing. For personalized assistance, reach out to our expert regulatory consultants who specialize in CDSCO licensing for gastroenterology devices.
By following this detailed, actionable guide, manufacturers and importers can confidently navigate the CDSCO licensing process, ensuring timely market access and compliance for absorbent enteric stomal dressings in India.
