CDSCO License for Uterine manipulator cervical cup/transilluminator

Comprehensive Guide to CDSCO Licensing for Uterine Manipulator Cervical Cup/Transilluminator

The uterine manipulator cervical cup, a Class B medical device, is essential in gynecological surgeries like hysterectomy. Its primary function is to allow precise manipulation of the uterus under suction while preventing laparoscopic insufflation gas from escaping through the cervix. Given its critical role in obstetrical and gynecological procedures, adhering to India's regulatory framework is vital for market entry and patient safety.

CDSCO Regulatory Framework for Uterine Manipulator Cervical Cup

In India, the Central Drugs Standard Control Organization (CDSCO) governs medical device regulation. Devices like the uterine manipulator cervical cup fall under the ambit of the Medical Device Rules (MDR) 2017, which classify devices into four risk categories: A, B, C, and D. This device is categorized as Risk Class B, indicating moderate risk.

For Class B devices, the manufacturing license is issued by the State Licensing Authority through the MD5 licensing process. Compliance with the MDR ensures that the device meets safety, quality, and performance standards mandated by CDSCO.

Risk Classification and License Requirements

• Device Name: Uterine manipulator cervical cup/transilluminator
• Risk Class: B (Moderate risk)
• Category: Obstetrical and Gynecological
• Notification: File No. 29/Misc./03/2020-DC (181)
• Notification Date: 03.6.2022

As a Class B device, you are required to obtain an MD5 manufacturing license, which involves:

• Submission of a test license application (Form MD13) for product testing
• Product testing at government-approved laboratories
• Audit by a notified body
• Submission of the manufacturing license application (Form MD3)

Manufacturing License Process (MD5)

The MD5 license process is designed to ensure that Class A and B devices meet quality and safety benchmarks before market entry. Here is a stepwise breakdown:

1. Apply for Test License (Form MD13): Before manufacturing, apply for a test license that permits limited production for testing purposes. This step takes approximately 1.5 to 2 months.

2. Product Testing: Conduct product testing in government-approved laboratories to validate device safety and performance. Refer to the list of testing laboratories recognized by CDSCO.

3. Prepare Regulatory Documentation: Compile essential documents such as Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) documents.

4. Submit Manufacturing License Application (Form MD3): File your application through the CDSCO MD Online Portal. The State Licensing Authority will review your application.

5. Audit by Notified Body: An audit is conducted by a notified body listed on the Notified Bodies List to assess compliance with MDR standards.

6. Query Resolution: Respond promptly to any queries raised by the department or notified body.

7. Grant of License (Form MD5): Upon successful review and audit, the manufacturing license is granted.

Manufacturing License Documents Required

To facilitate a smooth application, ensure you have the following documents ready:

• Company Constitution/Registration Certificate
• Proof of Ownership or Lease Agreement of Manufacturing Premises
• Details of Technical Staff and their Qualifications
• Fire NOC and Pollution Control NOC
• Device Master File (DMF): Comprehensive details of device design, manufacturing process, and specifications. Our detailed Device Master File guide can assist in preparation.
• Plant Master File (PMF): Details of the manufacturing facility and quality controls, explained in our Plant Master File guide.
• Essential Principles Checklist confirming compliance with safety and performance standards
• Risk Management File documenting identified risks and mitigation strategies (learn more on Risk Management)
• Test Reports from approved laboratories
• Device Labels and Instructions for Use (IFU)
• Quality Management System Documents (e.g., ISO 13485:2016 certification)

Import License Process (MD15)

If you intend to import the uterine manipulator cervical cup rather than manufacture it domestically, you must obtain an MD15 import license granted by the Central Licensing Authority. The process involves:

• Document preparation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485, CE Certificate, DMF and PMF, wholesale license, and company constitution
• Submission of application on the CDSCO MD Online Portal
• Resolution of any departmental queries
• License grant typically within 5-6 months

For detailed guidance, see our Import License Guide.

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certificate
• CE Certificate (if applicable)
• Device Master File and Plant Master File
• Wholesale License for distribution
• Company Constitution/Registration Certificate

Timeline and Processing Duration

Total time: Approximately 3 to 4 months for the entire manufacturing license process.

Government Fees and Costs

• Application Fee: ₹5,000 per application
• Product Fee: ₹500 per product

Additional costs may include fees for product testing and audit charges by notified bodies. Budgeting for unforeseen expenses is prudent.

Common Challenges and Solutions

• Delayed Testing Results: Engage with approved laboratories early and confirm their capacity to avoid bottlenecks.
• Incomplete Documentation: Use comprehensive checklists and expert review to ensure all documents meet CDSCO requirements.
• Audit Non-Compliance: Conduct internal audits before the notified body visit to identify and rectify gaps.
• Query Resolution Delays: Assign a dedicated regulatory liaison to respond swiftly to CDSCO queries.

Expert Consultation and Support

With over 25 years of experience and assistance to more than 500 companies, we offer end-to-end support for CDSCO licensing. From document preparation to audit readiness and query management, our expert consultants streamline your pathway to compliance.

Getting Started with Your CDSCO License Application

1. Assess your device classification and licensing pathway. Confirm the Class B status using the Medical Device Classification resource.
2. Prepare your Device and Plant Master Files. Utilize our guides to ensure thorough documentation.
3. Apply for the test license on the CDSCO MD Online Portal.
4. Schedule product testing at government-approved labs early in the process.
5. Engage a notified body for the audit and prepare for the inspection.
6. Submit your MD5 license application with complete documents and stay responsive to queries.

Embarking on CDSCO licensing for your uterine manipulator cervical cup requires diligence, expertise, and strategic planning. Partner with seasoned consultants who understand the nuances of Indian regulatory requirements to ensure a successful and timely license grant, enabling you to serve the Indian healthcare market effectively.