CDSCO License for Manual rectal irrigation system
Medical Device Information
Intended Use
A portable assembly of manually-operated devices designed to be used by or on a patient to irrigate the rectum with water, typically to provoke the defecation reflex for the evacuation of the bowels to treat/prevent constipation and reduce the risk of faecal incontinence.
Comprehensive Guide to CDSCO Licensing for Manual Rectal Irrigation Systems (Class B Medical Devices)
As a seasoned regulatory consultancy with over 25 years of experience and having supported more than 500 companies in securing their CDSCO licenses, we understand the nuances and challenges manufacturers face when entering the Indian medical device market. This detailed guide focuses on the Manual Rectal Irrigation System, a Class B gastroenterology device, and outlines the regulatory pathway, timelines, costs, and practical insights to help you navigate the CDSCO licensing process smoothly.
Understanding the Manual Rectal Irrigation System and Its Regulatory Importance
The Manual Rectal Irrigation System is a portable, manually-operated device intended to irrigate the rectum with water to facilitate bowel evacuation, primarily used to treat or prevent constipation and reduce fecal incontinence risk. Due to its direct interaction with the human body and its therapeutic purpose, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is mandatory for Indian manufacturing and import.
The device falls under Risk Class B (low to moderate risk) as per the CDSCO Medical Device Rules, 2017, notified under Gazette Notification 29/Misc./03/2020-DC (182) dated 27.09.2021. This classification impacts the licensing route, required documentation, fees, and timelines.
CDSCO Regulatory Framework for Manual Rectal Irrigation Systems
CDSCO regulates medical devices under the Medical Device Rules, 2017, which classify devices into Class A, B, C, and D based on risk. Class B devices like the Manual Rectal Irrigation System require a manufacturing license known as MD5 license granted by the State Licensing Authority.
Manufacturers also need to comply with quality management system standards such as ISO 13485:2016 and adhere to essential principles including safety, performance, and risk management.
Risk Classification and License Requirements
| Device Name | Risk Class | License Type | Licensing Authority |
|---|---|---|---|
| Manual Rectal Irrigation System | B | MD5 | State Licensing Authority |
The MD5 license process is less centralized than Class C/D (which require MD9 licenses) but involves rigorous documentation, testing, and audit by notified bodies.
Step-by-Step Manufacturing License Process (MD5)
- Obtain Test License (Form MD13): Before applying for the manufacturing license, applicants must obtain a test license to manufacture and test the device, which takes approximately 1.5 to 2 months.
- Product Testing: Conduct product testing at CDSCO-approved government laboratories. Testing ensures compliance with applicable standards and technical specifications.
- Document Preparation: Prepare all required documents, including Device Master File, Plant Master File, Risk Management File, Essential Principles Checklist, and Quality Management System documentation.
- Application Submission (Form MD3): Submit the manufacturing license application through the CDSCO MD Online Portal using Form MD3.
- Audit by Notified Body: An audit is conducted by a notified body from the CDSCO Notified Bodies List to verify compliance.
- Query Resolution: Address any queries raised by the CDSCO or the notified body promptly.
- License Grant (Form MD5): Upon successful audit and document verification, the MD5 manufacturing license is granted.
Essential Documents Required for MD5 License Application
- Company Constitution and Incorporation Certificates
- Proof of Ownership/Lease of Manufacturing Premises
- Details and Qualifications of Technical Staff
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) – Detailed design and manufacturing information (see our Device Master File guide)
- Plant Master File (PMF) – Manufacturing facility details (refer to Plant Master File guide)
- Essential Principles Compliance Checklist
- Risk Management File demonstrating compliance with safety norms (Risk Management insights)
- Test Reports from CDSCO-approved labs (Testing Laboratories)
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (ISO 13485:2016 certification)
Import License Process (MD15) for Manual Rectal Irrigation Systems
If you intend to import this device into India, you must apply for the MD15 import license granted by the CDSCO Central Licensing Authority. The process generally takes 5-6 months and involves:
- Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, CE Certificate, ISO 13485:2016, Device and Plant Master Files
- Submission of application using Form MD14 via the CDSCO MD Online Portal
- Resolution of queries from CDSCO
- Final license grant on Form MD15
Timeline and Processing Duration
| Process Step | Duration Estimate |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 3 - 4 weeks |
| Document Preparation | 1 - 2 weeks |
| Application Processing (MD5) | 2 - 3 months including audit |
| Total Time | Approx. 3 - 4 months |
Government Fees and Associated Costs
| Fee Type | Cost (INR) |
|---|---|
| MD5 Application Fee | 5,000 |
| Per Product Fee | 500 |
| Test License (MD13) Fee | Included in application |
| Testing Charges (Lab Fees) | Variable (approx. 20,000 - 50,000)* |
*Testing fees vary depending on the scope and number of tests required.
Common Challenges and Expert Solutions
- Delays in Testing and Audit: The testing phase often causes bottlenecks due to limited slots in government labs. Planning early and booking tests well in advance can mitigate delays.
- Incomplete Documentation: Inadequate technical files or missing certificates are common reasons for query issuance. Leveraging expert consultants ensures thorough document preparation.
- Notified Body Audit Non-Compliance: Many companies underestimate audit rigor. Pre-audit internal checks and mock audits help improve compliance.
- Query Resolution Delays: Prompt and precise responses to CDSCO queries can significantly shorten timelines.
Expert Consultation and Support
Our team has successfully navigated the CDSCO licensing landscape for over 500 companies, including those manufacturing Class B gastroenterology devices like the Manual Rectal Irrigation System. We offer services such as:
- Gap analysis and readiness assessment
- Document preparation and review
- Coordination with notified bodies and testing labs
- Training on compliance and risk management
We recommend engaging consultants early in the process to reduce risks and expedite approvals.
Getting Started with Your CDSCO License Application
- Assess Product Classification: Confirm your device as Class B using CDSCO guidelines (Medical Device Classification).
- Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
- Schedule Product Testing: Coordinate with CDSCO-approved labs (Testing Laboratories) early to avoid delays.
- Prepare Comprehensive Documentation: Use our Device Master File and Plant Master File guides.
- Engage a Notified Body: Choose from the list of notified bodies for your audit.
- Submit MD5 License Application (Form MD3): Ensure all documents and fees are in order.
- Prepare for Audit and Queries: Conduct internal audits and be ready to respond quickly.
By following these actionable steps and leveraging expert support, manufacturers of Manual Rectal Irrigation Systems can successfully obtain their CDSCO MD5 licenses and confidently enter the Indian market.
For tailored assistance and end-to-end regulatory support, connect with us today and benefit from decades of expertise in CDSCO licensing for medical devices.
