CDSCO License for Cardiac Catherization Kit
Medical Device Information
Intended Use
Cardiac catheterization is a general term for a group of procedures that are performed using this method, such as coronary angiography and left ventricle angiography
Comprehensive Guide to CDSCO Licensing for Cardiac Catheterization Kits (Class D Medical Devices)
As seasoned regulatory consultants with over 25 years of experience and having supported 500+ medical device manufacturers and importers, we understand the complexities of navigating India's regulatory landscape for high-risk devices like the Cardiac Catheterization Kit. This guide provides detailed, actionable insights tailored specifically for Class D devices under CDSCO regulations, ensuring a streamlined pathway for your product’s successful market entry.
Introduction to Cardiac Catheterization Kits and Regulatory Importance
The Cardiac Catheterization Kit is a critical medical device used for procedures such as coronary angiography and left ventricle angiography. Given its invasive nature and significant impact on patient outcomes, it is classified as a Class D device—the highest risk category under the CDSCO framework. Ensuring compliance with all regulatory requirements is not only mandatory but vital to safeguard patient safety and uphold quality standards.
CDSCO Regulatory Framework for Cardiac Catheterization Kits
Under the Indian medical device regulations, the Central Drugs Standard Control Organization (CDSCO) governs the approval and licensing of high-risk medical devices like the Cardiac Catheterization Kit. The device is notified under Notification 29/Misc/3/2017-DC (292), dated 06.06.2018, categorizing it within the 'Catheters' group.
Manufacturers and importers of Class D devices must secure an MD9 manufacturing license or an MD15 import license respectively, both issued by the Central Licensing Authority (CLA) of CDSCO.
Risk Classification and License Requirements for Cardiac Catheterization Kits
- Risk Class: D (Highest Risk)
- License Type:
- Manufacturing: MD9 License (Application Form MD7)
- Import: MD15 License (Application Form MD14)
- Authority: Central Licensing Authority (CLA)
Given the device’s classification, the regulatory process is rigorous, involving extensive testing, documentation, and inspections to ensure compliance with essential principles and risk management standards.
Manufacturing License Process (MD9) for Cardiac Catheterization Kits
Test License Acquisition (Form MD13): Before applying for the MD9 license, manufacturers must obtain a Test License, which typically takes 1.5 to 2 months. This allows production of limited quantities for testing purposes.
Product Testing: Samples must be tested at government-approved notified laboratories to verify safety and efficacy. You can access the list of approved testing laboratories via the CDSCO portal.
Document Preparation: Compile comprehensive documentation, including Device Master File (DMF), Plant Master File (PMF), Risk Management File, and Quality Management System (QMS) documents.
Application Submission: File the MD9 application (Form MD7) through the CDSCO MD Online Portal with all supporting documents.
Audit and Inspection: CDSCO inspectors conduct a detailed audit of manufacturing facilities and documentation.
Response to Queries: Address any queries or observations raised by CDSCO during the audit.
License Grant: Upon satisfactory compliance, the MD9 license is issued on Form MD9.
For an in-depth overview, refer to our MD9 License Guide.
Manufacturing License Documents Required for MD9 Application
- Company Constitution (e.g., MOA, AOA)
- Proof of Ownership or Lease of Manufacturing Premises
- Details of Qualified Technical Staff and their qualifications
- Fire and Pollution No Objection Certificates (NOCs)
- Device Master File (DMF) detailing design, components, and manufacturing process (Device Master File Guide)
- Plant Master File (PMF) describing the manufacturing site and facilities (Plant Master File Guide)
- Essential Principles Compliance Checklist
- Risk Management File adhering to ISO 14971 (Risk Management Guidance)
- Test Reports from Notified Laboratories
- Product Labels and Instructions for Use (IFU)
- Quality Management System documentation (ISO 13485:2016 certification is highly recommended)
Import License Process (MD15) for Cardiac Catheterization Kits
Importers must apply for an MD15 license via the CDSCO MD Online Portal. The process involves:
Document Preparation: Collect and prepare all necessary documents including manufacturing license of the foreign manufacturer, Free Sale Certificate, CE Certificate, DMF, PMF, and ISO 13485 certificates.
Application Submission: Submit Form MD14 for MD15 license.
Review and Queries: CDSCO evaluates the documentation and may raise queries.
License Issuance: Upon clearance, MD15 import license is granted.
For comprehensive stepwise guidance, our Import License Guide is an excellent resource.
Import License Documents Required for MD15 Application
- Valid Manufacturing License of the foreign manufacturer
- Free Sale Certificate from the country of origin
- ISO 13485:2016 Certificate
- CE Certificate (if applicable)
- Device Master File
- Plant Master File
- Wholesale License
- Company Constitution documents
- Product labels and IFU
Timeline and Processing Duration
| License Type | Total Processing Time |
|---|---|
| MD9 Manufacturing | Approximately 4 to 5 months |
| Test License (MD13) | 1.5 to 2 months (pre-requisite) |
| MD15 Import | Approximately 5 to 6 months |
The timeline includes application review, laboratory testing, audits, and response to queries. Delays often arise from incomplete documentation or delayed responses to departmental queries.
Government Fees and Costs
| License Type | Application Fee | Per Product Fee |
|---|---|---|
| MD9 Manufacturing | ₹50,000 | ₹1,000 |
| MD15 Import | Class D: ₹2,25,000* | ₹1,12,500* |
*Note: The fees for import licenses are calculated based on the USD-INR exchange rate and CDSCO fee structure; Class D devices incur the highest fees.
Additional costs include laboratory testing fees, notified body audit charges, and consultancy fees if engaging external experts.
Common Challenges and Solutions
Challenge: Delays in obtaining test reports due to limited government-approved labs.
- Solution: Plan testing well ahead and consider multiple labs for parallel testing. Refer to the list of notified testing labs.
Challenge: Incomplete or inconsistent documentation leading to audit observations.
- Solution: Meticulously prepare the Device Master File, Plant Master File, and Risk Management File. Leverage templates and checklists from our guides.
Challenge: Understanding complex regulatory requirements for Class D devices.
- Solution: Engage with experienced regulatory consultants to navigate the process efficiently.
Challenge: Managing timelines when coordinating testing, audits, and document preparation.
- Solution: Maintain a detailed project plan with buffer times for unforeseen delays.
Expert Consultation and Support
Our team has successfully guided over 500 companies through CDSCO licensing for high-risk medical devices, including cardiac catheterization kits. We offer end-to-end support—from initial gap analysis, document preparation, coordinating with notified bodies, to audit preparedness and regulatory submissions.
By partnering with us, you reduce risks of rejection, accelerate approval timelines, and ensure compliance with the latest regulatory standards.
Getting Started with Your CDSCO License Application for Cardiac Catheterization Kits
Assess Your Current Compliance Status: Conduct a gap analysis of your manufacturing or import setup against CDSCO requirements.
Register on the CDSCO MD Online Portal: Submit all applications through the official CDSCO MD Online Portal.
Prepare Test License Application (Form MD13): For manufacturers, initiate the test license process early to avoid bottlenecks.
Engage Accredited Testing Laboratories: Identify government-approved labs for timely product testing.
Compile Comprehensive Documentation: Utilize our Device Master File and Plant Master File guides for accurate document preparation.
Schedule and Prepare for Audits: Coordinate with notified bodies and CDSCO inspectors, ensuring your facilities and QMS are audit-ready.
Respond Promptly to Queries: Maintain open communication with CDSCO to resolve any observations swiftly.
By following these practical steps and leveraging expert guidance, you can confidently navigate the CDSCO licensing process for your Cardiac Catheterization Kit, ensuring timely market access in India’s expanding medical device sector.
For personalized assistance or to start your application process, contact our regulatory experts today.
