CDSCO License for Multifunction cardiac electrode, paediatric
Medical Device Information
Intended Use
A non-sterile electrical conductor designed to be applied to a paediatric patient for automatic or manual defibrillation, external pacing, cardioversion, and electrocardiographic monitoring through transmission of cardiac bioelectric signals (typically from the thoracic surface) to devices that record/process the signals and potentially return electrical impulses [e.g., electrocardiograph, electrocardiographic monitor(s), defibrillator]. It is a disk-like electrode that is affixed to the skin with a special adhesive and a conductive gel (pre-gelled). It may be made of x-ray translucent materials and may include permanently attached lead wires. This is a single-use device.
Comprehensive Guide to CDSCO Licensing for Multifunction Cardiac Electrode (Paediatric) - Class C Device
As experienced regulatory consultants with over 25 years of expertise and having supported 500+ medical device companies, we understand the nuances of obtaining CDSCO licenses for complex devices like the multifunction cardiac electrode designed specifically for paediatric use. This device, classified as Class C under CDSCO's risk-based framework, plays a critical role in emergency cardiac care and monitoring. Obtaining the correct license is essential not only for compliance but also to ensure market access in India.
Understanding the Multifunction Cardiac Electrode (Paediatric) and Its Regulatory Importance
This multifunction cardiac electrode is a single-use, non-sterile electrical conductor designed to interface with paediatric patients for defibrillation, external pacing, cardioversion, and ECG monitoring. It transmits cardiac bioelectric signals to diagnostic and therapeutic devices such as defibrillators and ECG monitors. Given its direct interaction with vulnerable paediatric patients and its critical function in life-saving procedures, the device is rightly classified as Class C (moderate to high risk). Compliance with CDSCO regulations ensures the device meets safety, quality, and efficacy standards mandated by Indian health authorities.
CDSCO Regulatory Framework for Paediatric Cardiac Electrodes
The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Medical Devices Rules, 2017. Devices are classified into Classes A, B, C, and D based on risk, with Class C devices requiring the MD9 manufacturing license issued by the Central Licensing Authority.
For this multifunction cardiac electrode, the relevant notification is File No. 29/MiscJ03/2020-DC (150) dated 23.8.2021, which governs its categorization and regulatory pathway.
Risk Classification and License Requirements for Class C Devices
Class C devices are moderate to high-risk devices, including those used for life-supporting or life-sustaining functions but with less risk than Class D devices. The multifunction cardiac electrode’s critical clinical use in paediatrics places it firmly in Class C, requiring stringent regulatory oversight.
License type: MD9 Manufacturing License (Form MD7)
Licensing Authority: CDSCO Central Licensing Authority
Key steps:
- Test license on Form MD13
- Product testing in government-approved labs
- Submission of manufacturing license application
- CDSCO audit
- Query resolution
- License grant
Detailed guidance on MD9 licensing can be found in our MD9 License Guide.
Manufacturing License Process (MD9) for Multifunction Cardiac Electrode
Obtain Test License (MD13): Apply for a test license to manufacture the device for testing purposes. Processing takes approximately 1.5 to 2 months.
Product Testing: The multifunction cardiac electrode must be tested at CDSCO-approved laboratories for compliance with relevant Indian and international standards. Refer to the list of testing laboratories recognized by CDSCO.
Document Preparation: Prepare comprehensive documentation, including Device Master File, Plant Master File, Risk Management File, QMS documents, Essential Principles Checklist, and clinical evaluation reports.
Submit Application (MD7): File the manufacturing license application through the CDSCO MD Online Portal using Form MD7.
CDSCO Audit: The CDSCO officials will conduct a detailed audit of your manufacturing site and documentation.
Query Resolution: Address any queries or deficiencies raised during the audit and application review.
License Grant: Upon satisfactory compliance, the MD9 license will be issued.
Manufacturing License Documents Required
For MD9 licensing of the multifunction cardiac electrode, the following documents must be submitted:
- Company Constitution documents (e.g., incorporation certificate)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire No Objection Certificate (NOC)
- Pollution Control Board NOC
- Device Master File – detailed design and manufacturing processes (Device Master File guide)
- Plant Master File – manufacturing infrastructure and quality systems (Plant Master File guide)
- Essential Principles Checklist compliance
- Risk Management File (aligned with ISO 14971) (Risk Management guide)
- Product test reports from CDSCO-approved labs
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) documents, typically ISO 13485:2016 certification
Import License Process (MD15) for the Device
If you are an importer of this multifunction cardiac electrode, the import license (MD15) must be obtained from the CDSCO Central Licensing Authority.
Key steps include:
- Document preparation including manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016 certificate, CE certificate
- Submission of Form MD14 through the CDSCO MD Online Portal
- Query resolution
- Grant of MD15 license
Note that the import license process typically takes 5-6 months and does not require a test license.
Import License Documents Required
- Valid manufacturing license of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 certification
- CE Certificate or equivalent
- Device Master File and Plant Master File
- Wholesale license for importers
- Company Constitution documents
For detailed guidance, refer to our Import License Guide.
Timeline and Processing Duration
| License Type | Approximate Duration | Key Milestones |
|---|---|---|
| Test License (MD13) | 1.5 - 2 months | Application submission, testing |
| MD9 Manufacturing License | 4 - 5 months | Document prep, audit, query closure |
| MD15 Import License | 5 - 6 months | Document prep, query closure |
Given the sequential nature, manufacturers should plan for at least 5 months to complete MD9 licensing.
Government Fees and Costs
For the multifunction cardiac electrode (Class C), fees are as follows:
- MD9 License Application: Rs 50,000 per application
- Product Fee: Rs 1,000 per product
Additional costs include:
- Testing fees charged by government-approved labs
- Consultancy fees if engaging external experts
- Facility upgrades or documentation preparation costs
The application and payments are managed through the CDSCO MD Online Portal.
Common Challenges and Practical Solutions
Challenge: Delays in product testing due to lab backlogs.
Solution: Engage with CDSCO-listed laboratories early and confirm testing timelines. Prioritize documentation parallel to testing to reduce overall delays.
Challenge: Incomplete documentation leading to multiple queries.
Solution: Utilize checklists and templates for Device Master Files and Risk Management Files. Our detailed guides help ensure compliance from the outset.
Challenge: Audit non-conformities in manufacturing processes.
Solution: Implement ISO 13485:2016 certified QMS prior to audit and conduct internal audits to preempt findings.
Challenge: Confusion on classification and licensing requirements.
Solution: Reference the official Medical Device Classification and consult experienced regulatory experts.
Expert Consultation and Support
Navigating the CDSCO licensing process for Class C devices like the multifunction paediatric cardiac electrode demands detailed understanding and strategic planning. Our team has successfully guided over 500 companies through these regulatory pathways, ensuring timely approvals and compliance.
We provide:
- End-to-end application support
- Documentation preparation and review
- Quality system implementation assistance
- Audit readiness and post-audit support
Partnering with expert consultants drastically reduces approval timelines and prevents costly rejections.
Getting Started with Your CDSCO License Application
Assess Your Product Classification: Confirm that your multifunction cardiac electrode falls under Class C.
Register on the CDSCO MD Online Portal: Create your account and familiarize yourself with the portal’s functions.
Prepare Initial Documentation: Begin with company documents, technical staff details, and manufacturing premises proof.
Apply for Test License (MD13): Submit test license application to initiate product testing.
Engage Approved Testing Labs: Coordinate sample submission and testing.
Develop Comprehensive Technical Files: Device Master File, Plant Master File, Risk Management, and QMS documentation.
Submit MD9 License Application: Once testing and documentation are complete, apply via Form MD7.
Prepare for Audit: Conduct internal audits and training to ensure compliance.
Starting early, maintaining thorough documentation, and leveraging expert guidance are key to successfully obtaining your CDSCO MD9 license for this critical paediatric cardiac device.
For personalized assistance, reach out to our regulatory experts who will guide you through each step efficiently and effectively.
