CDSCO License for Foetal Doppler system probe
Medical Device Information
Intended Use
Placed on the surface of a pregnant woman's abdomen to detect foetal heart beats using ultrasonic/Doppler technology.

Comprehensive Guide to CDSCO Licensing for Foetal Doppler System Probe (Class C Medical Device)
As seasoned regulatory consultants with over 25 years of experience and having successfully assisted more than 500 companies, we understand the complexities involved in obtaining CDSCO licenses for medical devices like the Foetal Doppler System Probe. This device, classified as Class C under the Indian regulatory framework, is a vital obstetrical and gynecological tool used to detect foetal heartbeats via ultrasonic/Doppler technology. Navigating the CDSCO (Central Drugs Standard Control Organization) licensing process can be challenging, but with the right guidance, manufacturers and importers can smoothly enter the Indian market.
Understanding the Regulatory Importance of Foetal Doppler System Probe
The foetal Doppler system probe is a critical device that assists healthcare professionals in monitoring foetal well-being during pregnancy. Given its direct impact on maternal and foetal health, CDSCO classifies it as a Class C device under the notified medical device regulations (Notification File No. 29/Misc./03/2020-DC (181), dated 03.6.2022). This classification demands stringent compliance to ensure safety, effectiveness, and quality before market authorization.
CDSCO Regulatory Framework for Foetal Doppler System Probe
India’s CDSCO regulates medical devices through a risk-based classification system aligned with the Global Harmonization Task Force (GHTF) model. The Foetal Doppler System Probe falls under Class C, which is considered a moderate to high-risk device. Regulatory oversight is conducted by the Central Licensing Authority (CLA), and manufacturers must obtain an MD9 manufacturing license before marketing.
Risk Classification and License Requirements for Foetal Doppler System Probe
- Risk Class: C
- Regulatory Authority: Central Licensing Authority (CDSCO Headquarters)
- Applicable License: MD9 Manufacturing License (Form MD7)
- Mandatory Test License: MD13 (Test License for product testing)
You can verify device classification and relevant regulatory details on our comprehensive Medical Device Classification guide.
Step-by-Step Manufacturing License Process (MD9) for Class C Foetal Doppler System Probe
Obtain Test License (MD13):
- Submit application for test license to CDSCO.
- Timeline: Approximately 1.5 to 2 months.
- Purpose: To allow product testing in notified laboratories.
Product Testing:
- Conduct testing in CDSCO-approved testing laboratories.
- Testing includes safety, performance, and compliance with Indian standards.
- Reference the list of Testing Laboratories for accredited labs.
Document Preparation:
- Compile technical documentation including Device Master File (DMF), Plant Master File (PMF), Risk Management File, Essential Principles Checklist, and Quality Management System (QMS) certifications.
- Our detailed Device Master File guide and Plant Master File guide can assist you in preparing these critical documents.
Application Submission:
- Apply for MD9 license using Form MD7 on the CDSCO MD Online Portal.
Audit and Inspection:
- CDSCO inspectors conduct an on-site audit focusing on manufacturing facilities, quality management systems, and compliance with Good Manufacturing Practices (GMP).
- Prepare for queries and observations raised during this audit.
Resolution of Queries:
- Address any deficiencies or clarifications requested by CDSCO promptly to avoid delays.
Grant of License:
- Upon successful audit and document verification, CDSCO issues the MD9 license (Form MD9).
Manufacturing License Documents Required for Foetal Doppler System Probe
- Company Constitution (Incorporation Certificate, Memorandum & Articles of Association)
- Proof of Ownership or Lease of Manufacturing Premises
- Details and Qualification Certificates of Technical Staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File (DMF)
- Plant Master File (PMF)
- Essential Principles Checklist demonstrating compliance with Indian regulatory standards
- Risk Management File (per ISO 14971 principles) – see our guide on Risk Management
- Test Reports from CDSCO-approved laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (typically ISO 13485:2016 certification)
Import License Process (MD15) for Foetal Doppler System Probe
If you intend to import the Foetal Doppler System Probe into India rather than manufacture locally, an MD15 import license is mandatory. This license is granted by the Central Licensing Authority and typically requires:
- Valid manufacturing license from the country of origin
- Free Sale Certificate
- ISO 13485:2016 Certification
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License for distribution
The procedure involves document submission through Form MD14 on the CDSCO MD Online Portal, followed by scrutiny and license grant. The total timeline is approximately 5 to 6 months.
For a detailed walkthrough, refer to our Import License Guide.
Timeline and Processing Duration
Process Stage | Duration |
---|---|
Test License (MD13) | 1.5 – 2 months |
Product Testing | 1 – 1.5 months |
Document Preparation | Concurrent with Testing |
MD9 Application Submission | Immediate after testing |
CDSCO Audit and Inspection | 1 – 1.5 months |
Query Resolution and Final Approval | 2 – 4 weeks |
Total Estimated Time | 4 – 5 months |
Government Fees and Costs
For Class C devices such as the Foetal Doppler System Probe, the CDSCO fee structure is as follows:
- MD13 Test License Fee: Typically included in the overall MD9 process costs; confirm at application.
- MD9 Manufacturing License Application Fee: ₹50,000 per application.
- Per Product Fee: ₹1,000 per product variant.
Additional costs include product testing fees charged by laboratories (varies by test scope) and expenses related to audit readiness and documentation preparation.
Common Challenges and Solutions
Challenge: Delays in product testing due to high demand at government laboratories.
- Solution: Plan testing well in advance and consider private notified labs if available.
Challenge: Incomplete or inconsistent documentation leading to audit observations.
- Solution: Utilize expert consultants to prepare Device Master File and Plant Master File meticulously.
Challenge: Resolving queries from CDSCO inspectors can be time-consuming.
- Solution: Maintain transparent communication and provide comprehensive responses promptly.
Challenge: Understanding risk management documentation requirements.
- Solution: Implement a robust risk management system aligned with ISO 14971; our Risk Management guide offers valuable insights.
Expert Consultation and Support
Our extensive experience in CDSCO medical device licensing enables us to provide tailored support for Foetal Doppler System Probe manufacturers and importers. We assist with:
- Gap analysis of your current documentation and QMS
- Preparation and review of Device and Plant Master Files
- Coordination with notified testing laboratories
- Application submission and audit facilitation
- Prompt resolution of CDSCO queries
Our hands-on approach ensures you meet all regulatory requirements efficiently, reducing time-to-market.
Getting Started with Your CDSCO License Application
- Evaluate Your Current Status: Assess whether you are manufacturing locally or importing.
- Classify Your Device: Confirm Class C status and understand implications.
- Prepare Documentation: Begin compiling technical files and QMS documents.
- Apply for Test License (MD13): Submit application via the CDSCO MD Online Portal.
- Plan Testing and Audit: Schedule product testing and internal audits.
- Engage Expert Help: Consider consultancy support for seamless application processing.
For detailed guidance on MD9 manufacturing license, refer to our comprehensive MD9 License Guide.
Navigating the CDSCO licensing process for Class C devices like the Foetal Doppler System Probe requires strategic planning, meticulous documentation, and adherence to timelines. With our proven expertise, we empower manufacturers and importers to achieve compliance smoothly and bring safe, effective medical devices to the Indian healthcare ecosystem.