CDSCO License for Foetal Doppler system
Medical Device Information
Intended Use
Active non-invasive device to detect foetal heart beats using ultrasound/Doppler technology.
Comprehensive Guide to CDSCO Licensing for Foetal Doppler Systems (Class C Medical Device)
As specialists with over 25 years of experience in Indian medical device regulation, we have assisted more than 500 companies in successfully navigating the CDSCO licensing process. This guide focuses on obtaining regulatory approval for Foetal Doppler systems, an active non-invasive obstetrical device used to detect foetal heartbeats through ultrasound/Doppler technology, classified as a Class C medical device under the Indian regulatory framework.
Understanding the Foetal Doppler System and Its Regulatory Importance
Foetal Doppler systems are vital in prenatal care, offering early and safe detection of fetal heartbeats. Due to their active nature and critical use in obstetrics, these devices fall under Class C, indicating a moderate to high risk. Ensuring compliance with CDSCO regulations not only guarantees market access but also ensures patient safety and device efficacy.
CDSCO Regulatory Framework for Foetal Doppler Systems
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India. Since the notification dated 03.06.2022 (File No. 29/Misc./03/2020-DC (181)), Foetal Doppler systems are regulated under the Medical Device Rules, 2017, requiring a license before manufacturing or importing.
For Class C devices like Foetal Doppler systems, the license is issued centrally by CDSCO under the MD9 license category, following a stringent evaluation process.
Risk Classification and License Requirements for Foetal Doppler
- Risk Class: C (Moderate to high risk)
- License Type: MD9 Manufacturing License (Form MD7)
- Authority: Central Licensing Authority (CDSCO, New Delhi)
- Applicable Notification: 29/Misc./03/2020-DC (181)
You can verify your device classification and related information on the Medical Device Classification guide.
Manufacturing License Process for Foetal Doppler System (MD9 License)
The MD9 license process for Class C devices involves multiple stages:
- Test License Application (Form MD13): Apply for a test license allowing you to manufacture the device for testing and evaluation purposes. This step takes approximately 1.5 to 2 months.
- Testing at CDSCO-Approved Labs: Conduct mandatory product testing at government-approved testing laboratories. Refer to the Testing Laboratories list for accredited centers.
- Document Preparation: Compile detailed technical documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System (QMS) proof.
- License Application (Form MD7): Submit the final manufacturing license application on the CDSCO MD Online Portal.
- Inspection and Audit: CDSCO inspectors conduct audits and may raise queries.
- Query Resolution: Promptly respond to all departmental or audit queries.
- License Grant: Upon satisfactory review, the MD9 license is granted (Form MD9).
Manufacturing License Documents Required
For the MD9 application specific to Foetal Doppler systems, the following documents are essential:
- Company Constitution Documents: Certificate of Incorporation, Memorandum & Articles of Association
- Proof of Premises Ownership/Lease: Valid ownership or lease agreement
- Technical Staff Details: CVs and qualifications of key technical personnel
- Fire NOC & Pollution Control Board NOC: Compliance certificates from local authorities
- Device Master File (DMF): Detailed device design, specifications, and manufacturing process documentation. Our Device Master File guide offers comprehensive insights.
- Plant Master File (PMF): Information on manufacturing facilities and quality controls. See our Plant Master File guide for practical tips.
- Essential Principles Checklist: Compliance with Indian Medical Device Rules
- Risk Management File: Documentation of risk analysis, evaluation, and mitigation aligned with international standards. Learn more on Risk Management.
- Test Reports: Results from CDSCO-approved labs
- Labels and Instructions for Use (IFU): Compliance with labeling regulations
- Quality Management System (QMS) Documents: ISO 13485:2016 certification and internal manuals
Import License Process for Foetal Doppler Systems (MD15 License)
For importers of Foetal Doppler systems, an MD15 import license is mandatory. The process is centralized and includes:
- Document compilation including manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device Master File, Plant Master File, Wholesale License, and company constitution.
- Application submission through the CDSCO portal using Form MD14.
- Resolution of any raised queries.
- License grant typically within 5-6 months.
Our detailed Import License guide explains this process.
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 for distribution
- Company Constitution documents
Timeline and Processing Duration
| Process Step | Duration (Approx.) |
|---|---|
| Test License (MD13) | 1.5 – 2 months |
| Product Testing | 1 – 1.5 months |
| Document Preparation | 1 month |
| License Application & Audit | 1.5 – 2 months |
| Total (MD9 License) | 4 – 5 months |
The Import License (MD15) process usually takes 5-6 months due to comprehensive review.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 License | Rs. 50,000 | Rs. 1,000 |
| MD15 Import | Class C/D: Rs. 2,20,000* | Rs. 1,50,000* |
*Import fees are in INR equivalent of USD as per current rates.
Note: Fees are payable online through the CDSCO portal during application submission.
Common Challenges and Solutions
- Incomplete Documentation: Ensure all technical and compliance files are thorough; use checklists and expert reviews.
- Delays in Testing: Book slots early at CDSCO-approved labs and confirm sample requirements.
- Audit Non-Compliance: Prepare your manufacturing site and QMS per CDSCO guidelines and conduct mock audits.
- Query Resolution Delays: Respond promptly with detailed, clear answers supported by evidence.
Expert Consultation and Support
Navigating the MD9 and MD15 licensing process can be complex. Our team has a proven track record of streamlining applications, preparing technical files, coordinating with notified bodies, and expediting approvals. We provide end-to-end support—from initial classification to final license grant.
Getting Started with Your CDSCO License Application
- Classify your device accurately as Class C.
- Prepare your test license application (Form MD13) to start manufacturing samples.
- Engage with a CDSCO-approved testing laboratory early to schedule testing.
- Compile comprehensive technical documentation, including Device and Plant Master Files.
- Submit your application via the CDSCO MD Online Portal and monitor application status regularly.
- Schedule pre-audit consultations to ensure compliance readiness.
- Respond promptly to any queries from CDSCO or auditors.
By following these steps and leveraging expert guidance, manufacturers of Foetal Doppler systems can confidently enter the Indian market with full regulatory compliance. Contact us today to streamline your CDSCO licensing journey.
