CDSCO License for Manual enema device, reusable

Comprehensive Guide to CDSCO Licensing for Manual Enema Devices (Reusable) – Class B Medical Device

As seasoned regulatory consultants with over 25 years of experience and having supported 500+ companies in securing CDSCO licenses, we understand the intricacies involved in navigating India’s medical device regulations. This guide is tailored specifically for manufacturers and importers of Manual Enema Devices (Reusable), classified as Class B under CDSCO’s risk categorization.

Introduction: Manual Enema Device and Its Regulatory Importance

A manual enema device is designed to facilitate bowel evacuation by administering fluid into the rectum, stimulating peristalsis. Given its direct interaction with the human body and intended gastroenterology application, the device falls under Class B risk category, warranting thorough regulatory compliance to ensure patient safety and product efficacy.

Obtaining the appropriate CDSCO license is not just a legal mandate but a critical step to build trust with healthcare providers and consumers in India’s growing medical device market.

CDSCO Regulatory Framework for Manual Enema Devices

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Device Rules, 2017. For Class B devices like manual enema devices, the MD5 manufacturing license issued by the State Licensing Authority is mandatory for domestic manufacturers. Importers must secure an MD15 import license from the Central Licensing Authority.

The licensing process ensures compliance with quality standards, safety, essential principles, and post-market surveillance obligations.

Risk Classification and License Requirements for Manual Enema Devices

Manual enema devices are categorized as Class B owing to their moderate risk profile. This classification affects:

• Licensing Authority: State Authority for manufacturing (MD5 license)
• Application Form: MD3 for manufacturing license
• Testing & Compliance: Mandatory pre-market testing and audit

For imports, the MD15 license is issued by CDSCO’s central office.

For full details on classification, consult the Medical Device Classification resource.

Manufacturing License Process (MD5) for Manual Enema Devices

1. Obtain Test License (Form MD13): Before applying for MD5, manufacturers must secure a test license for product evaluation, taking approximately 1.5 to 2 months.
2. Product Testing: Conduct product testing at government-approved labs listed on the CDSCO Testing Laboratories portal.
3. Document Preparation: Compile necessary documents including Device Master File, Plant Master File, Quality Management System (QMS) evidence, and Risk Management files.
4. Submit Application (Form MD3): Apply through the CDSCO MD Online Portal for the manufacturing license.
5. Audit by Notified Body: An audit is conducted by a notified body listed on the Notified Bodies List to verify compliance.
6. Respond to Queries: Address any clarifications or deficiencies raised during audit or by CDSCO.
7. Receive License (Form MD5): Upon successful review and audit clearance, the license is granted.

Manufacturing License Documents Required for Manual Enema Devices

• Company constitution and legal incorporation documents
• Proof of ownership or lease of manufacturing premises
• Qualification details of technical staff
• Fire and Pollution NOCs
• Device Master File detailing design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File outlining infrastructure and quality systems (Plant Master File Guide)
• Essential Principles Checklist confirming device compliance
• Risk Management File as per ISO 14971 (Risk Management)
• Product test reports from CDSCO-approved labs
• Product labels, packaging, and Instructions for Use (IFU)
• Quality Management System documentation (preferably ISO 13485 compliant)

Import License Process (MD15) for Manual Enema Devices

Importers must apply for the MD15 license through the central CDSCO office:

1. Document Preparation: Compile manufacturing license, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate, Device and Plant Master Files, wholesale license, and company constitution.
2. Application Submission: File application on the CDSCO MD Online Portal using Form MD14.
3. Review and Queries: Address any departmental queries.
4. License Grant: Upon satisfactory review, MD15 license is granted.

Import License Documents Required

• Valid manufacturing license from the country of origin
• Free Sale Certificate
• ISO 13485:2016 certification
• CE Certificate (if applicable)
• Device and Plant Master Files
• Wholesale license
• Company constitution documents

Timeline and Processing Duration

The total manufacturing license process for a Class B device like the manual enema device typically spans 3 to 4 months, factoring in testing and audit timelines. Import licensing takes slightly longer due to central authority processing.

Government Fees and Costs

For MD5 Manufacturing License (Class B):

• Application Fee: ₹5,000
• Per Product Fee: ₹500

For MD15 Import License:

• Per Site Fee: ₹2,000
• Per Product Fee: ₹1,000

These fees are subject to revision by CDSCO and are payable online during application submission.

Common Challenges and Solutions

• Delayed Testing Results: Labs may have backlogs; plan testing early and choose labs with shorter turnaround times.
• Incomplete Documentation: Refer to checklists and expert guides to ensure all files—especially Device Master File and Risk Management—are complete.
• Audit Non-Compliance: Engage with notified bodies early, conduct internal audits, and prepare your team to avoid surprises.
• Query Resolution Delays: Respond promptly and comprehensively to CDSCO queries to prevent application stalling.

Expert Consultation and Support

With our extensive experience in CDSCO licensing, we assist clients in:

• Preparing robust Device and Plant Master Files
• Streamlining test license and product testing processes
• Coordinating with notified bodies and government labs
• Ensuring full compliance with Medical Device Rules
• Managing documentation and audit readiness

Our expert insights can significantly reduce your time-to-market and avoid costly rejections.

Getting Started with Your CDSCO License Application

1. Assess Your Device Classification: Confirm your manual enema device is Class B using Medical Device Classification.
2. Prepare Technical Documentation: Start compiling your Device Master File and Risk Management File.
3. Apply for Test License (MD13): Submit your application on the CDSCO MD Online Portal.
4. Coordinate Product Testing: Schedule testing with approved laboratories.
5. Plan for Audit: Select a notified body from the official Notified Bodies List and prepare your site accordingly.
6. Submit Manufacturing License Application (MD3): Once testing and documentation are ready.

By following these actionable steps and leveraging professional support, manufacturers and importers of manual enema devices can navigate the CDSCO licensing process efficiently and compliantly.

For personalized assistance, feel free to connect with our regulatory experts who have successfully facilitated over 500 CDSCO licenses across various medical device categories.