CDSCO License for Fallopian tube catheterization kit

Comprehensive Guide to CDSCO Licensing for Fallopian Tube Catheterization Kits

As seasoned regulatory consultants with over 25 years of experience and having supported more than 500 companies, we understand the critical importance of securing the correct CDSCO license for your medical device. The Fallopian Tube Catheterization Kit — a Class B obstetrical and gynecological device used for transuterine catheterization to evaluate tubal patency — requires precise adherence to the Indian regulatory framework to enter the market smoothly.

CDSCO Regulatory Framework for Fallopian Tube Catheterization Kits

The Central Drugs Standard Control Organization (CDSCO) regulates medical devices in India under the Medical Device Rules (MDR) 2017. This device falls under Class B (low-moderate risk), governed by the State Licensing Authority for manufacturing licenses (MD5) and Central Licensing Authority for imports (MD15).

The official notification for this device is recorded as File No. 29/Misc./03/2020-DC (181), dated 03.06.2022, confirming its classification and regulatory oversight.

Risk Classification and License Requirements

Fallopian Tube Catheterization Kits are classified as Class B devices due to their invasive nature and moderate risk profile. This classification mandates:

• Manufacturing License: MD5 License (Application Form MD3) through the State Licensing Authority
• Import License: MD15 License (Application Form MD14) through the Central Licensing Authority

For manufacturing, the process includes obtaining a test license (MD13), product testing, documentation, and audit by a notified body.

Learn more about device classes on our Medical Device Classification guide.

Manufacturing License Process (MD5)

The MD5 license process for a Class B obstetrical device like the Fallopian Tube Catheterization Kit typically requires 3-4 months from start to finish. The steps include:

1. Apply for Test License (Form MD13): This preliminary license allows product testing and takes about 1.5 to 2 months.

2. Product Testing: Conduct product testing in a government-approved laboratory. A list of Testing Laboratories is available to choose from.

3. Document Preparation: Compile comprehensive documentation including Device Master File, Plant Master File, Risk Management File, and Essential Principles Checklist.

4. Application Submission: File the MD5 license application (Form MD3) via the CDSCO MD Online Portal.

5. Audit: Undergo inspection by an approved Notified Body to verify compliance.

6. Query Resolution: Address any queries from the regulatory authority or audit team promptly.

7. License Grant: Upon successful review, receive the manufacturing license (Form MD5).

For a detailed walkthrough, refer to our MD5 License Guide.

Manufacturing License Documents Required

Preparing a flawless application package is critical. For the Fallopian Tube Catheterization Kit, ensure you have:

• Company Constitution (incorporation documents)
• Proof of ownership or lease of manufacturing premises
• Qualification and experience certificates of technical staff
• Fire and Pollution No Objection Certificates (NOCs)
• Device Master File (DMF): Detailed product specifications, design, and manufacturing process (DMF Guide)
• Plant Master File (PMF): Description of manufacturing facilities and quality systems (PMF Guide)
• Essential Principles Checklist demonstrating compliance with Indian regulations
• Risk Management File, including hazard analysis and mitigation (Risk Management Guide)
• Product Test Reports from CDSCO-approved labs
• Labeling and Instructions for Use (IFU) as per MDR requirements
• Quality Management System (QMS) documentation, preferably ISO 13485 compliant

Import License Process (MD15)

Manufacturers or distributors importing Fallopian Tube Catheterization Kits must apply for an MD15 license, processed by the Central Licensing Authority. This process typically takes 5-6 months and involves:

1. Document Preparation: Compile requisite documents including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate (if applicable), Device and Plant Master Files.

2. Application Submission: Submit Form MD14 through the CDSCO MD Online Portal.

3. Review and Queries: Respond to any departmental queries.

4. License Grant: Receive the import license (Form MD15).

Import License Documents Required

• Valid Manufacturing License from the country of origin
• Free Sale Certificate
• ISO 13485:2016 Certification
• CE Certificate or equivalent
• Device Master File and Plant Master File
• Wholesale License in India (if applicable)
• Company Constitution documents

For a comprehensive overview, check our Import License Guide.

Timeline and Processing Duration

Timely submission of complete documentation and prompt query responses can significantly influence approval speed.

Government Fees and Costs

For the Fallopian Tube Catheterization Kit (Class B), the fee structure is as follows:

• MD5 Manufacturing License: Rs. 5,000 per application + Rs. 500 per product

• MD15 Import License:

  • Rs. 2,000 per site
  • Rs. 1,000 per product

Additional costs include testing fees at government-approved laboratories and audit fees charged by notified bodies.

Common Challenges and Solutions

Challenge: Delays due to incomplete documentation or non-compliance with Essential Principles.

Solution: Engage experienced consultants early to prepare the Device and Plant Master Files meticulously and ensure thorough risk management documentation.

Challenge: Difficulty in coordinating testing and audit timelines.

Solution: Schedule testing and audits proactively, leveraging CDSCO’s approved lists of laboratories and notified bodies.

Challenge: Understanding regulatory queries and responding effectively.

Solution: Maintain open communication channels with CDSCO and engage consultants who specialize in query resolution.

Expert Consultation and Support

Navigating the CDSCO licensing process for Class B devices requires expertise and attention to detail. Our 25+ years of regulatory experience ensures that your Fallopian Tube Catheterization Kit’s application is robust and compliant. From document preparation to audit support, we offer end-to-end assistance to minimize delays and maximize approval success.

Getting Started with Your CDSCO License Application

1. Verify Classification: Confirm that your device is Class B using the official classification resources.

2. Prepare Documentation: Begin compiling your Device Master File and Plant Master File. Our guides on DMF and PMF provide practical templates and checklists.

3. Apply for Test License: Submit Form MD13 via the CDSCO MD Online Portal.

4. Select Testing Laboratory: Choose a CDSCO-approved testing lab from the official list and initiate product testing.

5. Plan Audit: Coordinate with a notified body listed on the CDSCO portal for your manufacturing facility audit.

6. Submit Final Application: Complete and submit Form MD3 for the MD5 license, ensuring all documents and test reports are attached.

7. Prepare for Queries: Designate a responsive team to handle any regulatory queries promptly.

By following these actionable steps and leveraging our expertise, manufacturers and importers can confidently navigate the CDSCO licensing process for the Fallopian Tube Catheterization Kit, ensuring timely market access in India.

For personalized assistance and tailored regulatory strategies, feel free to contact our consultancy team.