CDSCO License for External counterpulsation system, paediatric
Medical Device Information
Intended Use
A noninvasive, stationary assembly of devices intended to assist the blood circulation of a paediatric patient suffering from heart disease through the electrocardiogram (ECG) synchronized inflation of pressure cuffs worn around the extremities/buttocks. It includes a patient bed with attached inflatable cuffs, an air pump, ECG cables, a control unit with dedicated software, and may include additional monitoring devices (e.g., pulse oximeter probe). The cuffs are intended to inflate from the most distal (e.g., lower leg) to the most proximal (e.g., buttocks) during diastole and deflate during systole to achieve increased preload and decreased afterload.
Introduction to External Counterpulsation System (Paediatric) and Regulatory Importance
The External Counterpulsation System (Paediatric) is a specialized medical device designed to assist blood circulation in pediatric patients with heart disease. By synchronizing inflation of pressure cuffs with the ECG signal, this noninvasive system enhances cardiac function by increasing preload and decreasing afterload. Given its critical role in pediatric cardiovascular care, regulatory compliance with the Central Drugs Standard Control Organization (CDSCO) is essential for market entry in India.
We have supported over 500 medical device manufacturers in navigating CDSCO licensing requirements, ensuring timely approvals with full regulatory compliance. This comprehensive guide focuses on the CDSCO requirements specifically for the External Counterpulsation System (Paediatric), classified as a Class B device under CDSCO’s risk classification.
CDSCO Regulatory Framework for External Counterpulsation System (Paediatric)
The CDSCO regulates all medical devices imported, manufactured, or sold in India under the Medical Device Rules (MDR) 2017. The External Counterpulsation System (Paediatric) falls under Class B, which generally covers devices with low to moderate risk.
According to the notification (File No. 29/MiscJ03/2020-DC (150), dated 23.8.2021), this device is recognized under the Pediatrics and Neonatology category and is subject to specific regulatory scrutiny due to its intended use in vulnerable pediatric populations.
Risk Classification and License Requirements
As a Class B device, the External Counterpulsation System (Paediatric) requires an MD5 manufacturing license granted by the State Licensing Authority. Importers must obtain an MD15 import license from the Central Licensing Authority.
Key points:
- Class B Device: Moderate risk
- Manufacturing License: Form MD3 application for MD5 license
- Import License: Form MD14 application for MD15 license
For a detailed overview of medical device classification, manufacturers can refer to our Medical Device Classification guide.
Manufacturing License Process (MD5) for Class B Devices
Manufacturers aiming to produce the External Counterpulsation System (Paediatric) in India must follow the MD5 licensing process:
- Test License Application (Form MD13): Obtain a test license to manufacture samples for testing. This phase typically takes 1.5 to 2 months.
- Product Testing: Submit device samples to government-approved laboratories. Testing laboratories can be found via the CDSCO’s Testing Laboratories list.
- Document Preparation: Compile all required documentation including Device Master File, Plant Master File, Risk Management File, and Quality Management System documents.
- Submit Manufacturing License Application (Form MD3): File the application for an MD5 license on the CDSCO MD Online Portal.
- Audit by Notified Body: Engage a notified body listed here for facility inspection and compliance verification.
- Address Queries: Respond promptly to any queries raised by the CDSCO or notified body.
- License Grant (Form MD5): Upon satisfactory compliance, the manufacturing license is granted.
The entire process from test license to MD5 grant generally takes 3 to 4 months.
Manufacturing License Documents Required
For the External Counterpulsation System (Paediatric), manufacturers must submit a comprehensive dossier including:
- Certificate of Incorporation and Company Constitution (MOA/AOA)
- Proof of ownership or lease of manufacturing premises
- Details and qualifications of technical staff
- Fire and Pollution NOCs
- Device Master File (DMF) detailing device specifications and design (Device Master File Guide)
- Plant Master File describing manufacturing processes (Plant Master File Guide)
- Essential Principles Checklist confirming compliance with CDSCO standards
- Risk Management File documenting risk analysis and mitigation (Risk Management Guide)
- Product test reports from CDSCO-recognized labs
- Labels and Instructions for Use (IFU) compliant with Indian regulations
- Quality Management System documents (ISO 13485:2016 certification preferred)
Preparing these documents with precision is critical to avoid delays during the audit and review stages.
Import License Process (MD15) for External Counterpulsation System (Paediatric)
Importers of this device must apply for the MD15 license from the Central Licensing Authority. The process includes:
- Document Preparation: Assemble required documents such as manufacturing license of the foreign manufacturer, Free Sale Certificate, ISO 13485:2016, CE Certificate, Device and Plant Master Files, and wholesale license.
- Application Submission: File Form MD14 for import license via the CDSCO MD Online Portal.
- Query Resolution: Address any clarifications requested by CDSCO officials.
- License Issuance (Form MD15): Upon successful review, the import license is granted.
Unlike the manufacturing license, no test license is required for import applications. The entire process typically spans 5 to 6 months.
Import License Documents Required
Key documents for MD15 license include:
- Valid manufacturing license from country of origin
- Free Sale Certificate or equivalent
- ISO 13485:2016 certification
- CE Certificate or other international conformity marks
- Device Master File and Plant Master File
- Wholesale license for import and distribution
- Company Constitution and address proof
Ensuring all documents are current and correctly formatted reduces processing time significantly.
Timeline and Processing Duration
| License Type | Process Duration | Key Milestones |
|---|---|---|
| MD5 Manufacturing | 3 to 4 months | Test License (1.5-2 months), Testing, Audit |
| MD9 Manufacturing | 4 to 5 months | Similar steps with central authority |
| MD15 Import | 5 to 6 months | Document submission and review |
Timelines can vary depending on document completeness and audit scheduling.
Government Fees and Costs
MD5 License (Class B):
- Application fee: Rs 5,000
- Per product fee: Rs 500
MD15 Import License (Class B):
- Site fee: USD 2,000
- Per product fee: USD 1,000
Budgeting for these fees along with costs related to testing, audit preparations, and consultancy is vital.
Common Challenges and Solutions
- Incomplete Documentation: Meticulously prepare and cross-verify all documents. Our detailed checklists help prevent common oversights.
- Delays in Testing: Engage CDSCO-approved labs early. Refer to the Testing Laboratories list to select suitable labs.
- Audit Non-compliance: Conduct pre-audit internal assessments and training sessions for staff.
- Query Management: Respond to CDSCO queries promptly and comprehensively to avoid unnecessary delays.
Expert Consultation and Support
Our 25+ years of experience in CDSCO licensing empowers us to guide you through every step—from documentation to audit readiness. Leveraging our expertise ensures smooth navigation of regulatory complexities and faster approvals.
We provide tailored solutions for manufacturers and importers of pediatric cardiovascular devices like the External Counterpulsation System, helping you mitigate risks and comply with all regulatory mandates.
Getting Started with Your CDSCO License Application
To initiate your licensing process for the External Counterpulsation System (Paediatric):
- Assess Device Classification: Confirm Class B status and licensing pathway.
- Prepare Documentation: Begin compiling your Device Master File, Plant Master File, risk management, and quality system documents.
- Apply for Test License (MD13): Submit your initial test license application via the CDSCO MD Online Portal.
- Select Testing Laboratory: Choose a government-approved lab to perform mandatory product testing.
- Engage Notified Body: Schedule audits with a notified body from the official list.
- Consult Experts: Reach out for consulting support to streamline your application and ensure compliance.
Starting early and maintaining proactive communication with regulatory authorities will help you meet all requirements efficiently. Our team is ready to assist you in securing your CDSCO MD5 manufacturing license and MD15 import license for your External Counterpulsation System (Paediatric), ensuring your entry into the Indian market is successful and compliant.
