Medical Device License for Cardiovascular Devices
Cardiovascular devices are life-saving medical instruments designed to diagnose, monitor, and treat heart and vascular conditions. These devices include pacemakers, stents, heart valves, and diagnostic equipment that are critical for managing cardiovascular health.
The Central Drugs Standard Control Organization (CDSCO) regulates all cardiovascular devices under the Medical Device Rules, 2017. Whether you manufacture or import, obtaining the correct CDSCO license is mandatory for legal market access, patient safety, and product credibility.
With over 25 years of experience and 500+ successful licenses, our team guides you through every regulatory step—ensuring your cardiovascular devices meet the highest standards of safety, quality, and compliance.
Key CDSCO Licenses for Cardiovascular Devices
MD5 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- Audit by Notified Body
MD9 Manufacturing License
- Test License (MD13)
- Product Testing
- Documentation
- CDSCO Audit
MD15 Import License
- Dossier Preparation
- Foreign Certificates
- Application Submission
- CDSCO Review
All Articles on Cardiovascular Devices
CDSCO License for Carotid sinus nerve stimulator
Expert guidance on obtaining CDSCO MD9 license for Carotid Sinus Nerve Stimulator Class D device, detailing timelines, costs, and document requirements for smooth regulatory approval.
CDSCO License for Implantable pacemaker pulse generator
Expert guidance on obtaining CDSCO MD9 license for implantable pacemaker pulse generators with timelines, costs, document checklists, and practical tips for Class D cardiovascular devices.
CDSCO License for Annuloplasty ring
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C cardiovascular annuloplasty rings, with timelines, costs, and document checklists.
CDSCO License for Pacing system analyzer
Expert guidance on obtaining CDSCO MD9 license for Pacing System Analyzer, detailing timelines, costs, and documentation for Class C cardiovascular devices.
CDSCO License for Cardiopulmonary bypass heart-lung machine console
Expert guide to CDSCO licensing for Cardiopulmonary bypass heart-lung machine consoles, covering risk class B requirements, timelines, costs, and practical regulatory insights.
CDSCO License for External transcutaneous cardiac pacemaker
Navigate CDSCO licensing for Class C External Transcutaneous Cardiac Pacemakers with expert guidance on timelines, costs, and documentation for smooth market entry.
CDSCO License for Cardiac monitor (including cardiotachometer and rate alarm)
Comprehensive guide to obtaining CDSCO MD5 license for Class B cardiac monitors, detailing timelines, costs, documents, and expert tips from 25+ years’ experience.
CDSCO License for Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm)
Expert guidance on obtaining CDSCO MD9 license for Class C Arrhythmia Detector devices, detailing timelines, costs, and document requirements for smooth market entry.
CDSCO License for Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure
Navigate the CDSCO MD9 license process for Class C extracorporeal circuits with expert guidance on timelines, costs, documentation, and practical steps for successful market entry in India.
CDSCO License for Electrocardiograph
Expert guide to obtaining CDSCO MD5 license for Class B Electrocardiograph devices, covering timelines, costs, documents, and practical tips for a smooth regulatory journey.
CDSCO License for Replacement heart valve
Navigate the CDSCO MD9 license process for Replacement Heart Valves with expert guidance on timelines, costs, documentation, and practical tips to ensure successful market entry in India.
CDSCO License for Intraluminal artery stripper
Navigate the CDSCO licensing process for your Class B Intraluminal Artery Stripper with expert guidance on timelines, documents, and costs to ensure smooth market entry in India.
CDSCO License for Pacemaker lead adaptor
Expert guidance on CDSCO MD9 license for pacemaker lead adaptors (Class C), detailing timelines, costs, documentation, and practical steps for smooth regulatory approval in India.
CDSCO License for Cardiovascular permanent or temporary pacemaker electrode
Expert guide to CDSCO MD9 license for cardiovascular pacemaker electrodes: timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Vena cava clip
Expert guidance on obtaining CDSCO MD5 manufacturing license for Class B Vena Cava Clip devices, including timelines, costs, documentation, and practical tips.
CDSCO License for Cardiopulmonary bypass defoamer
Expert guidance on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Cardiopulmonary Bypass Defoamer devices, including timelines, costs, and key documentation.
CDSCO License for Echocardiograph
Expert guide to obtaining CDSCO MD5 license for Echocardiograph (Class B) with detailed timelines, costs, documentation, and practical tips for smooth regulatory approval.
CDSCO License for Cardiopulmonary bypass vascular catheter, cannula, or tubing
Expert guidance on obtaining CDSCO MD5 license for Cardiopulmonary bypass vascular catheters (Class B) with timelines, costs, and document requirements for smooth regulatory approval.
CDSCO License for Electrocardiograph electrode
Expert guide for obtaining CDSCO MD5 license for Electrocardiograph electrodes (Class B devices) with timelines, costs, documents, and practical tips for smooth approval.
CDSCO License for Apexcardiograph (vibrocardiograph)
Expert guidance on obtaining CDSCO MD5 license for Apexcardiograph (Class B) devices with detailed timelines, costs, and document requirements for smooth regulatory approval.
CDSCO License for Intra-aortic balloon control system (balloon pump)
Expert guidance on obtaining CDSCO MD5 license for the Intra-aortic balloon control system (Class B), including timelines, costs, documents, and practical regulatory insights.
CDSCO License for Pacemaker repair or replacement material
Expert guidance on obtaining CDSCO MD9 license for Class D pacemaker repair/replacement materials with detailed timelines, costs, and document requirements.
CDSCO License for Pacemaker generator function analyzer
Expert guide to CDSCO MD9 license for Pacemaker Generator Function Analyzer (Class C), detailing timelines, costs, documents, and practical steps for smooth regulatory approval in India.
CDSCO License for Vascular clip
Expert guidance on obtaining CDSCO MD5 manufacturing license for Vascular Clips (Class B), covering timelines, costs, documentation, and practical steps for smooth regulatory approval in India.
CDSCO License for Cardiopulmonary bypass arterial line blood filter
Comprehensive guide to obtaining CDSCO MD9 license for Cardiopulmonary Bypass Arterial Line Blood Filter (Class C), covering timelines, costs, documents, and practical tips.
CDSCO License for Pacemaker test magnet
Navigate the CDSCO licensing process for Pacemaker Test Magnets (Class A) with expert guidance on timelines, costs, and documentation to ensure timely market entry in India.
CDSCO License for Cardiopulmonary bypass pulsatile flow generator
Expert guide to obtaining CDSCO MD9 license for Class D Cardiopulmonary bypass pulsatile flow generators, with timelines, costs, and practical tips.
CDSCO License for Cardiopulmonary bypass temperature controller
Expert guidance on obtaining CDSCO MD5 license for Cardiopulmonary Bypass Temperature Controllers, detailing timelines, costs, document requirements, and practical regulatory insights.
CDSCO License for Cardiopulmonary bypass bubble detector
Expert guide to securing CDSCO MD5 license for Cardiopulmonary Bypass Bubble Detector with timelines, costs, and document requirements for Class B cardiovascular devices.
CDSCO License for External cardiac compressor
Navigate the CDSCO licensing process for Class C External Cardiac Compressors with expert guidance on timelines, costs, documentation, and regulatory compliance.
CDSCO License for Cardiopulmonary bypass heat exchanger
Expert guidance on obtaining CDSCO MD5 license for Cardiopulmonary Bypass Heat Exchanger (Class B), including timelines, costs, documentation, and practical regulatory insights.
CDSCO License for Endomyocardial biopsy device
Navigate the CDSCO licensing process for Class D Endomyocardial Biopsy Devices with expert guidance on timelines, costs, documents, and compliance for smooth market entry in India.
CDSCO License for Intra-aortic balloon
Expert guide to securing CDSCO MD9 license for Intra-aortic Balloons, detailing timelines, costs, documentation, and practical tips for Class C cardiovascular devices.
CDSCO License for Pacemaker programmers
Expert guide on obtaining CDSCO MD9 manufacturing and MD15 import licenses for Class C pacemaker programmers, detailing timelines, costs, documents, and practical tips.
CDSCO License for Ventricular bypass (assist) device
Expert guidance on obtaining CDSCO MD9 license for Class D Ventricular Bypass Devices, including timelines, costs, documentation, and practical tips to streamline your application.
CDSCO License for Cardiopulmonary bypass cardiotomy suction line blood
Expert guidance on obtaining CDSCO MD5 manufacturing license for Cardiopulmonary Bypass Cardiotomy Suction Line Blood filters, including timelines, costs, and document requirements.