CDSCO License for Rectal/colonic lavage support 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, noninvasive devices intended to be used in conjunction with a rectal and/or colonic irrigation system to support the introduction of an irrigation solution into the rectum/colon.
Comprehensive Guide to CDSCO Licensing for Rectal/Colonic Lavage Support Kits (Class A Medical Device)
Navigating regulatory compliance for medical devices in India can be complex, especially for gastroenterology products like the Rectal/Colonic Lavage Support Kit. This device, classified as Class A under CDSCO regulations, serves a vital role in assisting rectal and colonic irrigation procedures by facilitating the introduction of irrigation solutions safely and effectively. With over 25 years of regulatory expertise and having supported 500+ companies, we provide you with a detailed roadmap to secure your CDSCO manufacturing or import license with confidence.
Understanding the CDSCO Regulatory Framework for Rectal/Colonic Lavage Support Kits
The Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of medical devices in India. Your Rectal/Colonic Lavage Support Kit falls under Class A, the lowest risk category, which includes non-invasive and non-sterile devices. This classification influences the licensing pathway, documentation, fees, and timelines.
Since the device is notified under notification number 29/Misc./03/2020-DC (182) dated 27.09.2021, it is mandatory to comply with CDSCO requirements before manufacturing or importing.
Risk Classification and License Requirements
| Risk Class | Device Examples | Licensing Authority | License Form | Timeline* | Fees* |
|---|---|---|---|---|---|
| Class A | Rectal/Colonic Lavage Support Kit | State Licensing Authority | MD5 (Form MD3) | 3-4 months | Rs 5000 + Rs 500 per product |
*Approximate durations and fees; actual timelines may vary based on document completeness and audit scheduling.
Manufacturing License Process for Class A Devices (MD5 License)
For manufacturing this device in India, the MD5 license is mandatory. The process is multi-step:
- Apply for Test License (Form MD13): Obtain a test license to manufacture limited quantities for testing. This phase typically takes 1.5 to 2 months.
- Product Testing: Send samples to CDSCO-approved government testing laboratories. Testing duration varies but expect 1 to 1.5 months. Check the list of testing laboratories for eligible labs.
- Documentation Preparation: Compile the required technical and quality documents (detailed below).
- Application Submission (Form MD3): Submit the manufacturing license application via the CDSCO MD Online Portal.
- Audit by Notified Body: Coordinate with notified bodies for a plant audit. Refer to the Notified Bodies List.
- Query Resolution: Address any queries raised by CDSCO or the notified body promptly.
- License Grant (Form MD5): Upon successful audit and document review, receive the manufacturing license.
Manufacturing License Documents Required
- Company Constitution and Incorporation Certificates
- Proof of ownership/lease of manufacturing premises
- Details and qualifications of technical staff
- Fire NOC and Pollution Control Board Certificates
- Device Master File (DMF) detailing design, specifications, and manufacturing process (See our Device Master File guide)
- Plant Master File (PMF) describing manufacturing facilities and quality controls (Plant Master File guide)
- Essential Principles Checklist confirming compliance with Indian medical device standards
- Risk Management File showing hazard analysis and mitigation strategies (Risk Management guide)
- Test Reports from government-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documentation compliant with ISO 13485:2016
Import License Process (MD15 License) for Rectal/Colonic Lavage Support Kits
If you plan to import this device, you must secure an import license (MD15) from the CDSCO Central Licensing Authority. The process includes:
- Preparation of required documents (see below)
- Application submission through the CDSCO MD Online Portal
- Resolution of any queries raised by CDSCO
- Grant of import license (Form MD15)
Import License Documents Required
- Valid Manufacturing License issued by the country of origin
- Free Sale Certificate or Certificate of Market Authorization
- ISO 13485:2016 certification
- CE Certificate (if applicable)
- Device Master File and Plant Master File
- Wholesale Drug License
- Company Constitution and Incorporation Documents
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5–2 months |
| Product Testing | 1–1.5 months |
| Document Preparation | 1 month (variable) |
| Application Processing | 3–4 months (MD5) |
| Overall Manufacturing License | Approximately 3-4 months (post test license) |
| Import License Processing | 5-6 months |
Government Fees and Costs
- MD5 Manufacturing License: Rs 5000 per application + Rs 500 per product
- Test License (MD13): Fees as per CDSCO norms (varies)
- Import License (MD15): Varies by device class; for Class A devices, approximately 50 per product
Budget for additional costs such as notified body audits, testing lab fees, and QMS implementation.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all files, especially Device and Plant Master Files, are comprehensive. Utilize expert templates and guides.
- Delayed Testing: Early coordination with government-approved labs can help expedite product testing.
- Audit Non-Compliance: Conduct pre-audit internal checks and mock audits to prepare your facility.
- Query Management: Respond promptly and precisely to queries from CDSCO to avoid delays.
Expert Consultation and Support
Given the complexities, partnering with a regulatory consultant experienced in CDSCO licensing can streamline approvals. Our team has successfully guided over 500 manufacturers and importers, offering:
- End-to-end documentation preparation
- Liaising with CDSCO and notified bodies
- Pre-audit readiness and training
- Risk management and QMS implementation support
Getting Started with Your CDSCO License Application
- Assess Device Classification: Confirm Class A status using the official CDSCO Medical Device Classification.
- Register on CDSCO MD Online Portal: Create your account to start applications.
- Prepare Test License Application (Form MD13): Gather your initial documents and submit.
- Plan Product Testing: Identify and contact approved testing laboratories early.
- Develop Device and Plant Master Files: Use our detailed guides to ensure compliance.
- Schedule Notified Body Audit: Early engagement helps align timelines.
- Submit Manufacturing License Application (Form MD3): Once test license and testing are complete.
Starting early with thorough preparation is key to meeting timelines and avoiding costly delays. For personalized assistance, consult with our regulatory experts who specialize in gastroenterology medical devices.
Embark on your CDSCO licensing journey confidently and bring your Rectal/Colonic Lavage Support Kit to the Indian market with full regulatory compliance.
