CDSCO License for Hysteroscopic irrigation/insufflation system
Medical Device Information
Intended Use
Used during endoscopic procedures of the uterus to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization and enlarge the surgical field. It also circulates the fluid to provide irrigation that will remove tissue/debris from the site.
Comprehensive Guide to CDSCO Licensing for Hysteroscopic Irrigation/Insufflation Systems (Class B Medical Device)
Navigating the complex regulatory landscape for medical devices in India can be challenging. With over 25 years of experience and having supported 500+ companies, we understand the nuances involved in securing CDSCO licenses efficiently. In this detailed guide, we focus on the Hysteroscopic irrigation/insufflation system, a Class B medical device under the Obstetrical and Gynecological category, outlining the entire process for obtaining the necessary CDSCO manufacturing license (MD5) along with practical tips to streamline your application.
Understanding the Hysteroscopic Irrigation/Insufflation System and Its Regulatory Importance
This device is used during endoscopic procedures of the uterus to distend the uterine cavity by filling it with a liquid, improving visualization and expanding the surgical field. Additionally, it circulates fluid to remove tissue and debris, making it a critical tool in gynecological surgeries.
Given its invasive use and patient contact, the Central Drugs Standard Control Organization (CDSCO) classifies it as a Class B medical device, necessitating adherence to regulatory standards to ensure safety and efficacy.
CDSCO Regulatory Framework for Class B Obstetrical and Gynecological Medical Devices
The CDSCO regulates medical devices in India through a risk-based classification system aligned with global standards. Class B devices such as the hysteroscopic irrigation system require a manufacturing license (MD5) issued by the State Licensing Authority. The licensing process ensures compliance with quality management systems, product safety, and clinical performance.
You can initiate the entire process by submitting your application through the CDSCO MD Online Portal, which streamlines documentation and tracking.
Risk Classification and License Requirements for the Hysteroscopic Irrigation/Insufflation System
- Device Category: Obstetrical and Gynecological
- Risk Class: B (Low to moderate risk)
- License Type: MD5 (Manufacturing License for Class A and B devices)
- Regulatory Authority: State Licensing Authority
Manufacturing License Process (MD5) Step-by-Step
Test License Application (Form MD13): Before you apply for the manufacturing license, you must obtain a test license to manufacture and test the device. This takes approximately 1.5 to 2 months.
Product Testing: Testing must be conducted at government-approved labs listed in the Testing Laboratories directory. Test reports are critical for license approval.
Document Preparation: Compile all required documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.
MD5 License Application (Form MD3): Submit the manufacturing license application.
Audit by Notified Body: The facility will undergo an audit by a notified body. You can check the list of notified bodies authorized for audits.
Resolution of Queries: Address any queries from the CDSCO or notified body promptly to avoid delays.
Grant of License: Upon successful compliance, the license is granted on Form MD5.
For detailed guidance, refer to our MD5 License Guide.
Manufacturing License Documents Required for Hysteroscopic Irrigation/Insufflation Systems
- Company Constitution and Incorporation Certificates
- Proof of Ownership or Lease Agreement of Manufacturing Premises
- Details of Technical Staff (Qualifications and Experience)
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF): Comprehensive details about design, manufacturing process, and specifications (see guide)
- Plant Master File (PMF): Details of the manufacturing facility and quality control processes (see guide)
- Essential Principles Checklist demonstrating compliance with Indian regulations
- Risk Management File following ISO 14971 standards (risk management insights)
- Test Reports from government-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System Documents (e.g., ISO 13485:2016 certification)
Import License Process (MD15) for Hysteroscopic Irrigation/Insufflation Systems
If you are an importer, the process differs slightly:
- License Type: MD15 Import License
- Authority: Central Licensing Authority (CDSCO HQ)
- Application Form: MD14
- Documentation: Manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate (if applicable), Device and Plant Master Files, Wholesale license, Company constitution.
The import license process takes approximately 5 to 6 months. For more details, our Import License Guide offers comprehensive insights.
Timeline and Processing Duration
| Process Step | Duration |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 2 – 3 weeks |
| MD5 License Application (MD3) | Submission & Review |
| Audit by Notified Body | 3 – 4 weeks |
| Query Resolution | 2 – 3 weeks |
| Total Time | Approx. 3 – 4 months |
Government Fees and Costs Breakdown
- Test License Fee (MD13): Rs. 5,000 (approximate)
- MD5 License Application Fee: Rs. 5,000 per application
- Product Fee: Rs. 500 per product
- Additional Costs: Testing fees at government-approved labs (varies by test scope), Notified body audit fees (varies by body)
Budgeting accurately for these costs is essential to avoid surprises during the regulatory journey.
Common Challenges and Practical Solutions
Challenge: Delays in obtaining test reports due to laboratory backlog.
Solution: Engage with multiple approved testing labs early and confirm their turnaround times. Prioritize labs with experience in gynecological devices.
Challenge: Audit non-compliance due to incomplete QMS documentation.
Solution: Develop a robust Quality Management System aligned with ISO 13485:2016 well before the audit. Conduct internal audits to identify gaps.
Challenge: Resolving regulatory queries leads to prolonged timelines.
Solution: Assign dedicated personnel for prompt query resolution and maintain clear communication with CDSCO.
Expert Consultation and Support for Your Hysteroscopic Device Licensing
Our extensive experience with over 500 successful CDSCO license applications means we can help you avoid common pitfalls. From document drafting to audit preparation and query management, we provide end-to-end support tailored to your hysteroscopic irrigation/insufflation system.
Getting Started with Your CDSCO License Application
Assess your device classification: Confirm your device is Class B using resources like our Medical Device Classification guide.
Prepare your Device and Plant Master Files: Refer to our guides to create comprehensive and compliant files.
Apply for Test License (MD13): Submit your test license application via the CDSCO MD Online Portal.
Plan product testing: Schedule testing at government-approved labs early.
Compile all required documents: Ensure completeness to avoid review delays.
Engage a notified body: Select from the official list of notified bodies for your audit.
Submit MD5 License Application: Once test reports and audit readiness are confirmed, apply for manufacturing license.
Prepare for audit and queries: Conduct mock audits and assign a response team.
Starting early and following a structured approach significantly improves your chances of timely approval and market entry.
For personalized assistance, feel free to connect with our regulatory experts who understand the nuances of gynecological devices and the Indian regulatory environment.
With the right preparation and expert guidance, obtaining your CDSCO MD5 license for the hysteroscopic irrigation/insufflation system can be a streamlined and predictable process. We are here to facilitate your journey every step of the way.
