Posted by The cardiovascular medical devices are classified according to the risk class they belong to. The classification is done by CDSCO (Central Drugs Standard Control Organization), the body which also approves the license for the devices for Indian manufacturers and importers.
Since the risk associated with the patient of these devices is significant, they are subject to a deep review and scrutiny. For this, you need to submit an application and specific documents. In this post, we’ll explain the CDSCO cardiovascular medical devices registration process in detail and the major challenges that may arise during filling. You will also find out how our expertise at Dueran Consultant makes the cardiovascular medical devices license approval easier.
What are Cardiovascular Medical Devices?
Cardiovascular devices are used in diagnosis and management of heart and blood vessel conditions. Typical examples include pacemakers, defibrillators, heart monitors, and the like. Many of these devices are inserted into the patient’s body. The devices also help medical staff of the critical condition of the patient and take steps to save their life. So, they need to adhere to high safety and quality standards.
CDSCO’s Regulatory Framework for Cardiovascular Medical Equipment
The regulatory framework for cardiovascular medical devices in India is governed by the Medical Devices Rules, 2017. Recently, CDSCO released a revised guideline for the risk-based classification list for cardiovascular medical devices.
To obtain a cardiovascular medical devices import license in India, you need to know the class of your medical device. Only after that, you can fill out the online application form in the Medical Device SUGAM portal and know the documents you need to submit.
CDSCO Classification list of Cardiovascular Medical Devices
| S No. | Medical Device Name | Risk Class |
| 1 | Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) | C |
| 2 | Cardiac monitor (including cardiotachometer and rate alarm) | B |
| 3 | Apexcardiograph (vibrocardiograph) | B |
| 4 | Echocardiograph | B |
| 5 | Electrocardiograph | B |
| 6 | Electrocardiograph electrode | B |
| 7 | Vascular clip | B |
| 8 | Vena cava clip | B |
| 9 | Intra-aortic balloon | C |
| 10 | Intra-aortic balloon control system (balloon pump) | B |
| 11 | Ventricular bypass (assist) device | D |
| 12 | Pacing system analyzer | C |
| 13 | Implantable pacemaker pulse generator | D |
| 14 | Pacemaker lead adaptor | C |
| 15 | Pacemaker generator function analyzer | C |
| 16 | Cardiovascular permanent or temporary pacemaker electrode | C |
| 17 | Pacemaker test magnet | A |
| 18 | Pacemaker programmers | C |
| 19 | Pacemaker repair or replacement material | D |
| 20 | Annuloplasty ring | C |
| 21 | Carotid sinus nerve stimulator | D |
| 22 | Replacement heart valve | D |
| 23 | Endomyocardial biopsy device | D |
| 24 | Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure | C |
| 25 | Cardiopulmonary bypass bubble detector | B |
| 26 | Cardiopulmonary bypass vascular catheter, cannula, or tubing | B |
| 27 | Cardiopulmonary bypass heart-lung machine console | B |
| 28 | Cardiopulmonary bypass defoamer | C |
| 29 | Cardiopulmonary bypass heat exchanger | B |
| 30 | Cardiopulmonary bypass temperature controller | B |
| 31 | Cardiopulmonary bypass arterial line blood filter | C |
| 32 | Cardiopulmonary bypass cardiotomy suction line blood | B |
| 33 | Cardiopulmonary bypass pulsatile flow generator | D |
| 34 | Intraluminal artery stripper | B |
| 35 | External cardiac compressor | C |
| 36 | External transcutaneous cardiac pacemaker | C |
CDSCO Approval Process for Cardiovascular Medical Devices
The approval process for obtaining the CDSCO cardiovascular medical devices registration is as follows:
- Check if the cardiovascular device comes under the CDSCO’s notified list. Apply for a No Objection Certificate (NOC) at the CDSCO, if not classified.
- Foreign manufacturers need to appoint an Authorized Indian Agent (IAA). The IAA will handle regulatory compliance and communication for the import and market of cardiovascular medical devices in India.
- Submit the application for cardiovascular devices license at CDSCO’s Medical Device Sugam portal.
- CDSCO will review the application and if something is needed, the authorities will raise a query online.
- Upon satisfactory review of submitted documents for cardiovascular medical equipment, CDSCO will issue a license.
- The CDSCO license for Cardiovascular medical devices in India shall remain valid in perpetuity, unless, it has been cancelled or surrendered, provided the license holder deposits the license retention fee every five years with the Licensing Authority.
Documents needed for CDSCO Cardiovascular Medical Devices Registration
The following documents are essential to submit for successful registration of your medical devices.
- Duly filled application form
- Power of Attorney (for foreign manufacturers)
- ISO 13485 Certificate (quality management system)
- Certificate of Quality Assurance
- Plant Master File (PMF)
- Device Master File (DMF)
- CE Certificates (if available)
- Proof of fee payment (Challan TR6)
Challenges Faced During CDSCO Registration For Cardiovascular Devices
The main challenges in front of the manufacturers and importers of cardiovascular medical devices in India are the need for extensive documentation, the requirement to match documents with long technical specifications, and due compliance with many authorities.
- Technical documents, reports pertaining to biocompatibility testing, risk management, and more, require a lot of time to gather. This detailed list of documents is often a challenge to compile.
- Separate fees are required for different Class of cardiovascular medical devices. If manufacturers and importers don’t know this, it leads to waste of time and resources.
- The registration process is typically lengthy, covering several months as per the risk class of your device. It also depends on the complexity and completeness of your application. If additional information or clarifications are needed and you cannot respond to them within due time, it delays the approval process.
- Manufacturers and importers of cardiovascular medical equipment face a hard time in keeping up with the changes in the Medical Devices Rules and CDSCO notifications.
Frequently Asked Questions (FAQ’s)
1. Who needs to register for CDSCO?
If you are involved in manufacturing, importing, exporting, selling, or doing research related to devices, registering for CDSCO is essential.
3. How long does CDSCO cardiovascular medical device registration take?
The timeline varies greatly. It can be as short as 2 to 4 months or as long as 9 to 12 months depending upon class of Medical Devices.
4. What are Classes of medical devices?
- Class A includes low-risk devices, like test magnet.
- Class B includes low-to-moderate-risk devices, like Cardiac monitor
- Class C has moderate-to-high-risk devices, like Intra-aortic Balloon.
- Class D has high-risk devices, like Ventricular Bypass Device.
Conclusion
Manufacturers and importers are required by CDSCO to provide proof of the safety, effectiveness, and performance of their cardiovascular medical devices. Before these products may be commercialized in India, their quality must be determined through extensive testing and documentation.
Observing the guidelines reduces the possibility of risk or injury to patients and medical professionals. But compliance might be daunting, particularly for new producers and importers. We guarantee that your devices are approved as quickly as possible by offering assistance and knowledge from the start to the finish. With our professional support, we engage with regulatory agencies on your behalf and eliminate the technical complexity required for compliance. Get in touch with Dueran Consultant for the economical, quickest authorization of your cardiovascular medical devices.
