CDSCO License for Enema tip, reusable

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

As seasoned regulatory consultants with over 25 years of experience assisting more than 500 companies in securing CDSCO licenses, we understand the nuances and challenges manufacturers face while entering the Indian medical device market. This guide focuses on the reusable Enema Tip, a Class A gastroenterology device made from Hevea natural rubber latex (NRL), detailing the regulatory pathway, document requirements, timelines, fees, and practical tips to streamline your licensing process.

Introduction: Understanding the Reusable Enema Tip and Its Regulatory Significance

The reusable Enema Tip is a critical accessory designed to connect to an enema tube, facilitating the delivery of enema solutions into the rectum. Classified as a low-risk medical device (Class A) under the CDSCO framework, it is non-sterile and made from natural rubber latex. Given its direct contact with mucous membranes, compliance with Indian regulatory standards is mandatory to ensure safety and market access.

The notified CDSCO notification for this device is 29/Misc./03/2020-DC (182) dated 27.09.2021. Proper licensing not only ensures legal compliance but also builds trust with clinicians and end-users.

CDSCO Regulatory Framework for Reusable Enema Tip (Class A Device)

In India, medical devices are regulated under the Medical Device Rules (MDR) 2017, enforced by the Central Drugs Standard Control Organization (CDSCO). The reusable Enema Tip falls under Class A (low risk), which means manufacturers require a Manufacturing License (MD5) granted by the State Licensing Authority.

The MD5 license process is designed to verify the manufacturer’s adherence to quality standards, proper testing, and documentation before market entry.

Risk Classification and License Requirements for Enema Tip

• Risk Class: A (Low Risk)
• License Type: MD5 (Manufacturing License for Class A and B devices)
• Regulatory Authority: State Licensing Authority

For detailed classification, manufacturers can refer to the Medical Device Classification guide.

Step-by-Step Manufacturing License Process (MD5) for Enema Tip

1. Obtain Test License (Form MD13):
   • Duration: 1.5 to 2 months
   • Purpose: To legally manufacture and conduct testing of the device
2. Product Testing:
   • Conduct testing of the Enema Tip at CDSCO-approved labs
   • Refer to the list of testing laboratories
3. Prepare Documentation:
   • Complete Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) documents
4. Submit Application (Form MD3) for MD5 License:
   • Submit via the CDSCO MD Online Portal
5. Notified Body Audit:
   • Engage with a notified body for facility audit
   • Check the list of notified bodies
6. Resolve Queries:
   • Address any queries raised by CDSCO or notified body promptly
7. Grant of License (Form MD5):
   • Upon satisfactory audit and document review

Manufacturing License Documents Required for Enema Tip

• Company Constitution documents (e.g., Certificate of Incorporation)
• Proof of ownership/lease agreement of manufacturing premises
• Details and qualifications of technical staff
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF): Detailed device description and specifications
• Plant Master File (PMF): Manufacturing processes and quality controls
• Essential Principles Checklist confirming compliance with CDSCO standards
• Risk Management File addressing potential hazards
• Test Reports from government-approved labs
• Labels and Instructions for Use (IFU)
• Quality Management System documentation (preferably ISO 13485 compliant)

Our comprehensive guides on Device Master Files and Plant Master Files can help you compile these critical documents efficiently.

Import License Process (MD15) for Enema Tip - Overview

Though your device is Class A and involves manufacturing in India, if you plan to import the Enema Tip, an Import License (MD15) from the Central Licensing Authority is mandatory. The process includes document preparation, application submission, and department review.

Documents required include Manufacturing License, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate if applicable, DMF, PMF, Wholesale License, and Company Constitution.

For detailed guidance, refer to our Import License Guide.

Timeline and Processing Duration for MD5 License

• Test License (MD13): 1.5 to 2 months
• Product Testing: 2 to 4 weeks
• Application Processing and Audit: 1.5 to 2 months
• Total Duration: Approximately 3 to 4 months

Government Fees and Costs

• Test License: No separate fee, part of the MD13 process
• MD5 Manufacturing License Fees:
  • Application Fee: Rs 5,000
  • Per Product Fee: Rs 500

This fee structure applies specifically to Class A devices like the reusable Enema Tip.

Common Challenges and Solutions

• Delayed Test Reports: Government-approved labs sometimes face backlogs. We recommend early submission and choosing labs with shorter turnaround times.
• Incomplete Documentation: Missing or inconsistent Device Master Files or Risk Management Files can lead to audit delays. Engage expert consultants to review documents before submission.
• Audit Non-Compliance: Not aligning manufacturing processes with QMS can cause negative audit findings. Conduct internal mock audits beforehand.
• Query Resolution Delays: Prompt and precise responses to CDSCO queries avoid unnecessary prolongation of the license process.

Expert Consultation and Support

Our extensive experience with over 500 successful CDSCO licenses enables us to provide tailored support, including document preparation, audit readiness, and liaison with CDSCO officials. Leveraging our expertise reduces risk and accelerates market entry.

Getting Started with Your CDSCO License Application for Reusable Enema Tip

1. Assess Your Manufacturing Setup: Ensure premises meet regulatory standards and your technical staff qualifications align with CDSCO requirements.
2. Compile Key Documents: Begin preparing your Device Master File, Plant Master File, and Risk Management Files using our detailed guides.
3. Register on CDSCO MD Online Portal: Submit your initial application for the Test License (MD13) via the CDSCO MD Online Portal.
4. Plan Product Testing: Coordinate with CDSCO-approved testing laboratories early to schedule testing.
5. Engage a Notified Body: Identify and appoint a notified body for your audit as per the list of notified bodies.
6. Prepare for Audit: Conduct internal audits to ensure compliance before the official audit.
7. Submit Manufacturing License Application (MD3): After test license and testing completion, submit your MD5 license application.

By following these practical steps and leveraging expert support, manufacturers of reusable Enema Tips can navigate the CDSCO licensing pathway efficiently, ensuring timely market authorization and compliance with Indian medical device regulations.

For personalized assistance, feel free to contact us — your trusted partner in medical device regulatory success.