CDSCO License for Cardiotocograph

Comprehensive Guide to CDSCO Licensing for Cardiotocograph (Class C Medical Device)

Cardiotocographs play a critical role in obstetrical and gynecological care by simultaneously recording fetal heart rate and uterine contractions to monitor fetal well-being during pregnancy and labor. Given their essential use, regulatory compliance is paramount to ensure safety and efficacy. Our 25+ years of expertise have helped over 500 manufacturers and importers navigate the complex CDSCO licensing process for such devices, especially those classified as Class C under the Indian medical device regulatory framework.

CDSCO Regulatory Framework for Cardiotocograph

Under the Drugs and Cosmetics Act, 1940 and subsequent Medical Device Rules (MDR) 2017, Cardiotocographs fall under the category of obstetrical and gynecological medical devices. As per the CDSCO notification File No. 29/Misc./03/2020-DC (181) dated 3rd June 2022, Cardiotocographs are classified as Class C devices, indicating moderate to high risk.

This classification entails stringent regulatory requirements including obtaining a Central License (MD9) for manufacturing and an Import License (MD15) for importers, governed by the Central Licensing Authority (CLA).

Risk Classification and License Requirements for Cardiotocograph

The Medical Device Rules classify devices into four categories – A, B, C, and D – based on risk. Cardiotocograph, being Class C, requires:

• Manufacturing License: MD9 License (Application Form MD7)
• Import License: MD15 License (Application Form MD14)

Both licenses are issued by the CDSCO Central Licensing Authority.

Manufacturing License Process (MD9) for Cardiotocograph

Obtaining the MD9 license is a multi-step process that typically spans 4 to 5 months. The steps include:

1. Test License Application (Form MD13): Before full license grant, manufacturers must obtain a test license to produce the device batch for testing. This takes about 1.5 to 2 months.
2. Product Testing: Samples of the Cardiotocograph must be tested at CDSCO-approved laboratories for compliance. Testing duration depends on the lab schedule but generally takes 3-4 weeks. Refer to the list of testing laboratories for options.
3. Document Preparation: Comprehensive documentation including technical files, quality management system (QMS) evidence, and risk management documentation must be compiled.
4. License Application Submission: Submit the application on the CDSCO MD Online Portal using Form MD7.
5. Inspection and Audit: CDSCO inspectors will conduct audits of manufacturing facilities and review documentation.
6. Query Resolution: Address any queries raised by the CDSCO promptly to avoid delays.
7. License Grant (Form MD9): Upon satisfactory review and audit, the manufacturing license is granted.

Manufacturing License Documents Required for MD9

For Cardiotocograph manufacturing license, ensure you prepare:

• Company Constitution (Memorandum and Articles of Association)
• Proof of ownership or lease of manufacturing premises
• Technical staff qualifications and CVs
• Fire NOC and Pollution Control Board NOC
• Device Master File (DMF) - detailing device design, specifications, and manufacturing process (Device Master File Guide)
• Plant Master File (PMF) - outlining manufacturing facilities and quality controls (Plant Master File Guide)
• Essential Principles Checklist for compliance with Indian MDR
• Risk Management File compliant with ISO 14971 standards (Risk Management)
• Test Reports from CDSCO-approved laboratories
• Product labels and Instructions for Use (IFU)
• Quality Management System documentation (ISO 13485:2016 certification preferred)

Import License Process (MD15) for Cardiotocograph

Importers seeking to bring Cardiotocographs into India must apply for an MD15 license. The process is comparatively straightforward but requires meticulous documentation. The timeline for MD15 licensing is about 5 to 6 months.

Process steps:

1. Document Compilation: Prepare all required documents including proof of manufacturing license from the country of origin.
2. Application Submission: File the application on the CDSCO MD Online Portal using Form MD14.
3. Query Resolution: Respond promptly to any departmental queries.
4. License Grant: Upon clearance, the import license (Form MD15) is issued.

Import License Documents Required

• Valid Manufacturing License (MD9 or equivalent) from the country of origin
• Free Sale Certificate (FSC) from the exporting country
• ISO 13485:2016 certificate
• CE Certificate or equivalent international compliance certificates
• Device Master File and Plant Master File
• Wholesale Drug License (if applicable)
• Company Constitution and address proof
• Product labels and IFU

Timeline and Processing Duration

Early preparation and prompt response to CDSCO queries can significantly reduce processing delays.

Government Fees and Costs for Cardiotocograph Licensing

• MD9 License:

  • Application Fee: Rs 50,000
  • Per Product Fee: Rs 1,000

• MD15 Import License:

  • Class C Device Fees: Rs 3,000 per site
  • Rs 1,500 per product

Additional costs include:

• Testing fees at CDSCO-approved laboratories
• Audit fees (if applicable)
• Consultancy and documentation preparation fees

Budgeting for these fees upfront avoids unpleasant surprises during the application process.

Common Challenges and Solutions

• Incomplete Documentation: Many applicants miss critical documents such as the Risk Management File or Device Master File. Solution: Use comprehensive checklists and expert review.
• Delayed Testing: Testing can be delayed due to lab backlogs. Solution: Pre-book slots at approved labs (Testing Laboratories).
• Audit Non-Compliance: Facilities not adhering to Good Manufacturing Practices (GMP) face audit failures. Solution: Conduct internal audits and training before CDSCO inspections.
• Slow Query Responses: Delays in addressing CDSCO queries extend timelines. Solution: Assign dedicated regulatory personnel for timely communication.

Expert Consultation and Support

With our extensive experience assisting over 500 companies in obtaining CDSCO licenses, we provide tailored support including:

• Pre-assessment of documentation and facility readiness
• Assistance in compiling Device and Plant Master Files
• Coordination with notified bodies and testing labs
• End-to-end application filing and follow-up
• Training on Indian MDR compliance and audit preparedness

Our expert guidance ensures your Cardiotocograph obtains timely approval with minimal hassle.

Getting Started with Your CDSCO License Application

1. Confirm Risk Classification: Verify your Cardiotocograph is Class C using the Medical Device Classification guide.
2. Prepare Documentation: Begin compiling all required documents, focusing on technical files, QMS, and risk management.
3. Obtain Test License: Apply for the MD13 test license via the CDSCO MD Online Portal to initiate product testing.
4. Schedule Product Testing: Coordinate with CDSCO-approved labs early to avoid delays.
5. Plan for Inspection: Ensure your manufacturing site complies with GMP and is ready for CDSCO audit.
6. Submit License Application: Apply for MD9 manufacturing license post successful testing and audit.
7. For Importers: Prepare import-specific documentation and apply for MD15 license.

Embarking on this journey with expert support and thorough preparation can significantly smooth your path to market entry. Reach out to us for a consultation tailored to your Cardiotocograph licensing needs.

For detailed insights on the MD9 license process, refer to our MD9 License Guide.

We are committed to helping you successfully navigate CDSCO regulations with confidence and efficiency.