CDSCO License for Enema tube

Comprehensive Guide to CDSCO Licensing for Enema Tubes (Class A Medical Device)

Navigating the regulatory landscape for medical devices in India requires detailed expertise, especially for critical yet common devices like the enema tube. As a Class A medical device with specific gastroenterology use, the enema tube plays a vital role in patient care by serving as a conduit for delivering enema solutions safely into the rectum. Given its non-sterile nature and low-risk classification, regulatory requirements are streamlined but precise to ensure safety and compliance.

With over 25 years of experience assisting 500+ companies in obtaining CDSCO licenses, we provide you with an actionable, detailed roadmap tailored for enema tubes under the CDSCO regime.

CDSCO Regulatory Framework for Enema Tubes

The Central Drugs Standard Control Organization (CDSCO) governs all medical device registrations and manufacturing licenses in India. Enema tubes are regulated as per the notification 29/Misc./03/2020-DC (182) dated 27.09.2021, which classifies them under the gastroenterology category as Class A devices — the lowest risk category.

Understanding this classification is essential as it determines the licensing authority, documentation, and timelines for approval.

Risk Classification and License Requirements for Enema Tubes

Class A medical devices include those with minimal risk to the user. Enema tubes fall squarely into this category due to their non-sterile, external use. For Class A devices, the manufacturing license is issued as an MD5 license by the State Licensing Authority.

Key points:

Risk Class: A
Licensing Authority: State FDA
License Type: MD5 (Application Form MD3)
Total Process Duration: Approximately 3-4 months

For detailed classification guidelines, you can refer to our Medical Device Classification resource.

Manufacturing License Process (MD5) for Enema Tubes

The MD5 license process is a multi-step procedure designed to ensure that manufacturers comply with quality, safety, and regulatory standards:

Test License (Form MD13): Initial step involves obtaining a test license, which typically takes 1.5 to 2 months. This allows you to manufacture samples for testing.
Product Testing: Samples must be tested at CDSCO-approved laboratories. For enema tubes, testing focuses on material safety, biocompatibility, and mechanical integrity. Refer to the Testing Laboratories List for approved facilities.
Document Preparation: Compile all required documents including Device Master File, Plant Master File, Essential Principles Checklist, Risk Management File, and Quality Management System (QMS) documentation.
Application Submission (Form MD3): Submit your manufacturing license application via the CDSCO MD Online Portal.
Audit by Notified Body: An audit is conducted by a notified body to verify compliance. Check the list of notified bodies for entities authorized for MD5 audits.
Query Resolution: Address any queries raised by the licensing authority or notified body promptly to avoid delays.
Grant of License (Form MD5): Upon satisfactory review, the State FDA grants the manufacturing license.

Manufacturing License Documents Required for Enema Tubes

To ensure a smooth application process, prepare the following documents meticulously:

Company Constitution (Certificate of Incorporation, Partnership Deed, etc.)
Proof of ownership or lease of manufacturing premises
Details and qualifications of technical staff
Fire NOC and Pollution Control Board NOC
Device Master File — covering design, specifications, and manufacturing process (Device Master File Guide)
Plant Master File detailing manufacturing infrastructure (Plant Master File Guide)
Essential Principles Checklist confirming compliance with safety norms
Risk Management File outlining hazard identification and mitigation (Risk Management)
Test Reports from CDSCO-approved labs
Product labels and Instructions for Use (IFU)
Quality Management System (QMS) documents including SOPs and records as per ISO 13485:2016

Import License Process (MD15) for Enema Tubes

If you plan to import enema tubes into India, you must apply for an MD15 import license granted by the Central Licensing Authority. Although enema tubes are Class A devices, the import license process is centralized and usually takes around 5-6 months.

Steps include:

Preparation of documents including free sale certificate, ISO 13485 certificate, CE certificate, Device and Plant Master Files
Submission of application on the CDSCO MD Online Portal
Query resolution
Grant of MD15 license

Refer to our Import License Guide for detailed insights.

Import License Documents Required

Valid Manufacturing License from the country of origin
Free Sale Certificate
ISO 13485:2016 certificate
CE Certificate or other international approvals
Device Master File
Plant Master File
Wholesale License in India (if applicable)
Company Constitution documents

Timeline and Processing Duration

Step	Timeline
Test License (MD13)	1.5 – 2 months
Product Testing	3 – 4 weeks
Document Preparation	3 – 4 weeks
Application Submission & Audit	4 – 6 weeks
Query Resolution & License Grant	2 – 3 weeks

Total Estimated Duration: 3 to 4 months for the complete MD5 license process.

Government Fees and Costs

Fee Category	Cost (INR)
Application Fee (MD5)	₹5,000
Per Product Fee	₹500

Additional costs to consider:

Testing laboratory fees (varies by test scope)
Notified body audit fees (varies by body)
Consultant fees for document preparation and application support

Common Challenges and Solutions

Challenge 1: Delays in Test License Approval

Solution: Submit a complete and error-free test license application; maintain proactive communication with licensing authorities.

Challenge 2: Incomplete or Non-compliant Documentation

Solution: Use checklists and templates aligned with CDSCO requirements; leverage expert guidance to ensure completeness.

Challenge 3: Audit Non-conformities

Solution: Conduct internal pre-audits; train staff on compliance; maintain updated QMS and records.

Challenge 4: Query Resolution Delays

Solution: Respond promptly with clear, evidence-based replies; engage regulatory consultants if necessary.

Expert Consultation and Support

Having navigated over 500 CDSCO licensing projects, we understand the nuances and evolving regulatory landscape. Our expert team assists manufacturers with:

Preparing robust Device and Plant Master Files
Coordinating with testing laboratories and notified bodies
Managing end-to-end application submissions via the CDSCO MD Online Portal
Training technical staff on compliance and audit readiness
Providing strategic solutions to overcome regulatory hurdles

Getting Started with Your CDSCO License Application for Enema Tubes

Assess and Classify: Confirm your device classification as Class A and verify its intended use aligns with the CDSCO notification.
Prepare Documentation: Begin assembling your Device Master File, Plant Master File, and Quality Management System documentation.
Apply for Test License (Form MD13): Submit through the CDSCO MD Online Portal to obtain permission for sample manufacturing and testing.
Coordinate Product Testing: Engage with accredited laboratories promptly to schedule and complete required testing.
Plan for Audit: Select a notified body from the official list and schedule your manufacturing site audit.
Submit Manufacturing License Application (Form MD3): Upload all documents and audit reports via the CDSCO portal.
Proactively Address Queries: Assign a dedicated team member or consultant to monitor and respond to any regulatory queries.

By following this structured approach, manufacturers and importers of enema tubes can confidently achieve CDSCO compliance and access the rapidly growing Indian medical device market with minimal hurdles.

For more tailored assistance, contact our regulatory experts who have decades of success in CDSCO licensing for Class A devices like enema tubes.

CDSCO License for Enema tube

Medical Device Information

Important Notice for Class A Devices

Intended Use