CDSCO License for Cardiovascular prosthetic devices
Medical Device Information
Intended Use
An intra-cardiac patch or pledgete which is a medical device placed in the heart and is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Comprehensive Guide to CDSCO Licensing for Cardiovascular Prosthetic Devices (Class D)
Cardiovascular prosthetic devices, such as intra-cardiac patches or pledgets, are critical internal prosthetic replacements used to repair septal defects, support patch grafting, and reinforce sutures within the heart. Given their life-sustaining function and high-risk profile, these devices fall under Class D according to the CDSCO medical device classification system. This classification entails stringent regulatory oversight to ensure product safety, efficacy, and quality before entering the Indian market.
With over 25 years of experience assisting 500+ companies in navigating CDSCO licensing, we provide you with an authoritative, actionable roadmap to obtaining the MD9 manufacturing license and import license for cardiovascular prosthetic devices.
CDSCO Regulatory Framework for Cardiovascular Prosthetic Devices
The Central Drugs Standard Control Organization (CDSCO) governs medical device regulation in India under the Ministry of Health and Family Welfare. Class D devices, including cardiovascular prosthetics, require a license from the Central Licensing Authority due to their high risk.
The regulatory framework mandates compliance with:
- Medical Device Rules 2017 (amended as applicable)
- Essential Principles of Safety and Performance
- Quality Management Systems (ISO 13485:2016)
- Clinical evaluation and risk management
The notified regulation for cardiovascular prosthetic devices is Notification 29/Misc/3/2017-DC (292), dated 06.06.2018.
Risk Classification and License Requirements for Cardiovascular Prosthetic Devices
Cardiovascular prosthetic devices used intra-cardiac fall under Class D (highest risk class). This classification influences licensing, audit, testing, and documentation requirements:
| Device Type | Risk Class | License Form | Licensing Authority | Typical Timeline | Fees (INR) |
|---|---|---|---|---|---|
| Cardiovascular Prosthetic Devices | D | MD9 (Form MD7) | CDSCO Central Authority | 4-5 months | ₹50,000 + ₹1,000 per product |
Class D devices require a thorough technical dossier, product testing in government-approved labs, and an audit by CDSCO inspectors.
Manufacturing License Process (MD9) for Class D Devices
The MD9 license process encompasses several critical steps:
- Test License Application (Form MD13): Before manufacturing, you must obtain a test license, which takes about 1.5 to 2 months.
- Product Testing: Conduct comprehensive testing in CDSCO-recognized laboratories to validate product safety and performance.
- Documentation Preparation: Compile essential documents including Device Master File, Plant Master File, Risk Management File, and Quality Management System details.
- License Application Submission (Form MD7): Apply via the CDSCO MD Online Portal with all supporting documents.
- Audit and Inspection: CDSCO inspectors will conduct a detailed audit of your manufacturing site and quality systems.
- Query Resolution: Address any queries or deficiencies raised by inspectors or the licensing authority.
- Grant of License (Form MD9): Upon successful compliance, the MD9 manufacturing license is issued.
For detailed guidance on the MD9 licensing process, refer to our MD9 License Guide.
Manufacturing License Documents Required for Cardiovascular Prosthetic Devices
The documentation package is extensive to assure regulatory compliance:
- Company Constitution Documents (e.g., incorporation certificate)
- Proof of Premises Ownership or Lease Agreement
- Technical Staff Qualifications and Experience
- Fire NOC and Pollution Control Board NOC
- Device Master File (DMF) detailing device design, materials, specifications (DMF Guide)
- Plant Master File (PMF) outlining manufacturing processes and infrastructure (PMF Guide)
- Essential Principles Checklist demonstrating compliance with safety requirements
- Risk Management File per ISO 14971 standards (Risk Management)
- Product Test Reports from CDSCO-approved labs (Testing Labs List)
- Labels and Instructions for Use (IFU)
- Quality Management System (QMS) Documents showing compliance with ISO 13485:2016
Import License Process (MD15) for Cardiovascular Prosthetic Devices
For importers, the MD15 import license is mandatory and granted by the Central Licensing Authority. The steps include:
- Document Preparation: Gather manufacturing license from the country of origin, Free Sale Certificate, ISO 13485:2016 certification, CE Certificate, and other key documents.
- Application Submission (Form MD14): Apply through the CDSCO MD Online Portal.
- Query Resolution: Respond promptly to any queries from CDSCO.
- License Grant (Form MD15): Typically takes 5-6 months for processing.
Required documents include:
- Valid manufacturing license from the exporting country
- Free Sale Certificate
- ISO 13485:2016 and CE Certificate
- Device Master File and Plant Master File
- Wholesale License (if applicable)
- Company Constitution Documents
Refer to our Import License Guide for in-depth details.
Timeline and Processing Duration
| Process Stage | Duration |
|---|---|
| Test License (MD13) | 1.5 - 2 months |
| Product Testing | 1 - 1.5 months |
| Document Preparation | 1 month (can overlap) |
| License Application Review | 1 month |
| Audit and Inspection | 1 month |
| Query Resolution | 2-4 weeks |
| Total Time | Approximately 4-5 months |
For imports, expect 5-6 months due to thorough scrutiny.
Government Fees and Costs
| License Type | Application Fee (INR) | Per Product Fee (INR) |
|---|---|---|
| MD9 Manufacturing License | 50,000 | 1,000 |
| MD15 Import License | Varies by class | Varies by class |
Note: Class D import license fees are approximately ₹230,000 per site plus ₹1,50,000 per product. Fees are payable online via the CDSCO portal.
Common Challenges and Solutions
Challenge: Delays in test license approval and product testing.
- Solution: Engage early with notified testing laboratories and pre-validate documentation to avoid back-and-forth.
Challenge: Insufficient documentation or incomplete risk management files.
- Solution: Utilize expert consultants to prepare or review your Device and Plant Master Files along with risk files.
Challenge: Audit non-compliance due to poor QMS implementation.
- Solution: Conduct internal audits and gap analyses before CDSCO inspection.
Challenge: Query response delays leading to extended timelines.
- Solution: Assign dedicated regulatory personnel for timely and accurate replies.
Expert Consultation and Support
Navigating CDSCO’s regulatory landscape for high-risk cardiovascular prosthetic devices can be complex. Our team has helped over 500 companies secure MD9 manufacturing and import licenses with a 98% success rate.
We offer:
- Comprehensive dossier preparation and review
- Liaison with CDSCO and notified bodies
- Pre-audit readiness assessments
- Risk management and QMS implementation support
Partnering with seasoned consultants reduces approval times and mitigates compliance risks.
Getting Started with Your CDSCO License Application
- Assess Your Device Classification: Confirm Class D status using the official Medical Device Classification resource.
- Initiate Test License Application: File Form MD13 via the CDSCO MD Online Portal to commence manufacturing tests.
- Engage an Approved Testing Laboratory: Select from the list of CDSCO-approved labs for product evaluation.
- Prepare Comprehensive Documentation: Develop Device Master File, Plant Master File, and Risk Management File with expert assistance.
- Schedule Pre-Audit Assessments: Ensure your QMS and manufacturing site meet CDSCO standards before the official inspection.
- Submit MD9 Application: Complete and submit Form MD7 along with all required documents.
- Respond Promptly to Queries: Monitor your application status actively and provide timely clarifications.
Starting early and following these steps diligently can streamline your license acquisition and enable timely entry into the Indian market.
For personalized assistance and end-to-end regulatory support for cardiovascular prosthetic devices, contact our expert team today.
