CDSCO License for Manual enema device
Medical Device Information
Intended Use
A non-sterile device intended to be used to manually administer fluid (e.g., saline solution) into the rectum to facilitate evacuation of the large intestine through expansion of the lower intestinal tract and physical stimulation of peristalsis.
Comprehensive Guide to CDSCO Licensing for Manual Enema Device (Class B)
As seasoned regulatory consultants with over 25 years of experience and more than 500 successful clients, we understand the nuances involved in securing CDSCO licenses for medical devices like the Manual Enema Device. This non-sterile gastroenterology device, classified as Class B under Indian regulations, requires a thorough regulatory approach to ensure compliance and timely market access.
Understanding the Manual Enema Device and Its Regulatory Importance
The Manual Enema Device is intended to manually administer fluids, such as saline solution, into the rectum to aid in evacuating the large intestine. This device plays a critical role in facilitating bowel movements by expanding the lower intestinal tract and stimulating peristalsis. Given its direct contact with the body and medical application, regulatory oversight by the Central Drugs Standard Control Organization (CDSCO) is mandatory to ensure safety, efficacy, and quality.
Proper licensing not only meets legal mandates but also instills confidence among healthcare providers and end users. Non-compliance can lead to severe penalties, product recalls, or bans, hampering your business operations.
CDSCO Regulatory Framework for Manual Enema Device
The Manual Enema Device falls under the gastroenterology category and is notified under CDSCO notification number 29/Misc./03/2020-DC (182) dated 27.09.2021. As a Class B medical device, it is subject to the regulatory pathway defined for medium-risk devices, requiring a manufacturing license known as the MD5 license, granted by the State Licensing Authority.
For detailed classification information, you can refer to the Medical Device Classification guide.
Risk Classification and License Requirements
- Device: Manual Enema Device
- Risk Class: B (Low to moderate risk)
- License Type: MD5 Manufacturing License (Form MD3)
- Authority: State Licensing Authority
- Process Duration: Approximately 3-4 months (including test license and audit)
The Class B classification requires adherence to safety standards and quality management systems but involves a relatively streamlined process compared to higher-risk Class C and D devices.
Manufacturing License Process (MD5) for Manual Enema Device
The MD5 license process is comprehensive and involves multiple steps:
Test License Application (Form MD13): Initiate by applying for the MD13 test license, which takes roughly 1.5 to 2 months to obtain. This license permits you to produce the device for testing purposes.
Product Testing: Get the device tested in government-approved laboratories listed on the CDSCO Testing Laboratories portal. This step ensures compliance with the essential principles and safety standards.
Documentation Preparation: Compile required documents including technical files, Device Master File (DMF), and Plant Master File (PMF).
License Application (Form MD3): Submit the application for the MD5 license through the CDSCO MD Online Portal.
Audit by Notified Body: Undergo an audit by a notified body approved for Class B devices; refer to the Notified Bodies List for selecting your auditor.
Resolution of Queries: Address any observations or queries from the CDSCO or notified body.
License Grant: Upon successful audit and document verification, the MD5 license is granted on Form MD5.
Manufacturing License Documents Required
To expedite your application, ensure you have the following documents ready:
- Company Constitution (Incorporation Certificate, Partnership Deed, etc.)
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details and qualifications of Technical Staff
- Fire Safety NOC
- Pollution Control NOC
- Device Master File (DMF) detailing design, components, and manufacturing process; our Device Master File guide offers practical steps to create this.
- Plant Master File (PMF) describing manufacturing facility and quality systems; see our Plant Master File guide for assistance.
- Essential Principles Checklist confirming compliance with safety and performance requirements
- Risk Management File demonstrating hazard identification and mitigation strategies; refer to our Risk Management resource
- Product Test Reports from approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents such as ISO 13485 certificates
Import License Process (MD15) for Manual Enema Device
If you plan to import the Manual Enema Device into India, an MD15 import license from the Central Licensing Authority is required. This process is distinct from manufacturing and involves:
- Preparation of key documents like existing manufacturing license, Free Sale Certificate, ISO 13485:2016, CE Certificate, DMF, PMF, and Wholesale License.
- Application submission on the CDSCO MD Online Portal.
- Resolution of any queries from CDSCO.
- License grant on Form MD15, usually within 5-6 months.
For detailed guidance, consult our Import License Guide.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 3 – 4 weeks |
| Documentation & Application | 2 – 3 weeks |
| Audit & Inspection | 3 – 4 weeks |
| Query Resolution & Approval | 2 – 3 weeks |
| Total Approximate Time | 3 – 4 months |
Government Fees and Costs
- Application Fee: Rs 5000 per application
- Per Product Fee: Rs 500 per product
Additional costs include laboratory testing fees (vary by test scope), audit fees payable to notified bodies, and costs related to document preparation and consultancy if engaged.
Common Challenges and Solutions
Challenge 1: Delays in Test License Approval
- Solution: Submit complete and accurate documents at first submission; monitor application through the CDSCO portal regularly.
Challenge 2: Incomplete or Insufficient Documentation
- Solution: Use our comprehensive checklists for DMF, PMF, and QMS documents to ensure compliance.
Challenge 3: Audit Non-Conformities
- Solution: Conduct internal pre-audit assessments and training to prepare your team and processes.
Challenge 4: Query Resolution Delays
- Solution: Assign a dedicated regulatory affairs manager to respond promptly and comprehensively.
Expert Consultation and Support
Navigating CDSCO licensing can be complex, especially for Class B devices like the Manual Enema Device. Our experienced team provides end-to-end support—from initial classification and documentation to audit readiness and application submission. We have helped over 500 companies successfully obtain their CDSCO licenses, minimizing delays and ensuring compliance.
Getting Started with Your CDSCO License Application
- Conduct a Regulatory Gap Analysis: Evaluate your current processes and documents against CDSCO requirements.
- Engage a Notified Body: Early engagement helps streamline the audit phase.
- Prepare Device and Plant Master Files: Utilize our guides to prepare robust files.
- Apply for Test License (MD13): Submit via the CDSCO MD Online Portal to initiate the process.
- Schedule Product Testing: Coordinate with government-approved labs promptly.
- Compile and Submit MD5 Application: Ensure all documents are complete to avoid delays.
- Prepare for Audit: Conduct internal audits and staff training.
Taking these actionable steps will set a strong foundation for a successful CDSCO license application for your Manual Enema Device. Reach out to our expert consultants to accelerate your journey to compliance and market entry.
