Cardiovascular medical devices are vital for the diagnosis and treatment of cardiovascular diseases. Given their vital role in the healthcare industry, they have to be stringently regulated. Hence, CDSCO, the apex medical device regulatory body, has formulated stringent regulations for cardiovascular medical devices. It aims to ensure safe, effective, and high-quality medical devices are available in the Indian healthcare infrastructure. The goal is to safeguard public health and improve patient outcome. Thus, compliance with CDSCO medical device regulations is non-negotiable to market your cardiovascular medical devices in India. Hence, securing the CDSCO cardiovascular medical device license is a mandatory requirement. We have prepared this guide to help you easily secure the CDSCO medical device license for cardiovascular devices.
Indian cardiovascular medical devices market: An overview
Cardiovascular medical devices are used to diagnose, monitor, and treat heart- and blood vessel-related conditions. As cardiovascular diseases are the leading cause of death globally, cardiovascular devices are in high demand. The Indian cardiovascular medical devices market size is estimated at approximately USD 1.62 billion in the year 2025. It is expected to attain approximately USD 2.23 billion by 2030. Moreover, the market is expected to grow at a CAGR of 6.6% during the period 2025 to 2030.
With changes in lifestyle and increasing prevalence of obesity, India is facing a growing burden of cardiovascular diseases. This is fuelling the demand for cardiac monitoring and treatment devices. Furthermore, the government is promoting the development of healthcare infrastructure and facilities, which need these devices. Additionally, the preference for minimally invasive cardiovascular surgical procedures is driving the demand for technically advanced cardiovascular devices. Growing awareness of cardiovascular diseases and the importance of preventive care are contributing to the demand for cardiac monitoring devices. Therefore, all these factors are boosting the Indian cardiovascular medical devices market.
The Indian cardiovascular medical devices market has a bright future. Entrepreneurs may choose to venture into this sector of medical devices.
CDSCO cardiovascular medical devices classification system
Medical devices have been classified based on the potential risks associated with their use. They are categorised into four classes, A, B, C, and D, in increasing order of risks. Notably, this classification system has been developed to simplify the CDSCO license application process. Moreover, different licenses and application processes are required for the different CDSCO classes.
CDSCO cardiovascular medical device classes
We have listed some examples of cardiovascular medical devices belonging to the different CDSCO classes.
Class A:
- Pacemaker test magnet
- Pacemaker service tools
Class B:
- Echocardiograph
- Electrocardiograph
- Vascular clip
- Vena cava clip
- Pacemaker generator function analyzer
- Endomyocardial biopsy device
- Cardiopulmonary bypass heart-lung machine console
- Cardiopulmonary bypass heat exchanger
- Cardiopulmonary bypass temperature controller
- Cardiopulmonary bypass cardiotomy suction line blood
- Intraluminal artery stripper
- Cardiopulmonary bypass bubble detector
- Cardiopulmonary bypass vascular catheter, cannula, or tubing
Class C:
- Electrocardiograph electrode
- Intra-aortic balloon and control system
- Pacemaker lead adaptor
- Annuloplasty ring
- Cardiopulmonary bypass arterial line blood filter
- External transcutaneous cardiac pacemaker
- Cardiopulmonary bypass defoamer
- Cardiopulmonary bypass arterial line blood filter
- External cardiac compressor
- Pacing system analyzer
Class D:
- Ventricular bypass (assist) device
- Implantable pacemaker pulse generator
- Pacemaker repair or replacement material
- Replacement heart valve
- Cardiopulmonary bypass pulsatile flow generator
- Carotid sinus nerve stimulator
Use our free tool to check the CDSCO class to which your cardiovascular medical device belongs to. This will determine your CDSCO cardiovascular medical device license application process.
CDSCO cardiovascular medical device license application process
We have created this mini guide to simplify your CDSCO medical device license application journey. With our support, you can secure the cardiovascular medical device license in a hassle-free manner.
CDSCO cardiovascular medical device license: Different license types and requirements
Different license and application processes apply for different CDSCO classes.
- Manufacturing class A and B cardiovascular medical devices: To manufacture class A and B cardiovascular medical devices in India, you need to apply for MD 5 license. Moreover, a fee of Rs. 5,000 for the manufacturing license will be required. Additionally, Rs. 500 for each distinct device will be required. The license has to be obtained from the state licensing authority.
- Manufacturing class C and D cardiovascular medical devices: To manufacture class C and D cardiovascular medical devices in India, you need to apply for MD 9 license. Moreover, a fee of Rs. 50,000 for the manufacturing license will be required. Additionally, Rs. 1,000 for each distinct device will be required. The license has to be obtained from the central licensing authority.
- Importing cardiovascular medical devices into India: To import cardiovascular medical devices into India, you need to secure MD 15 Import License from the CDSCO.
Documents required for securing CDSCO cardiovascular medical device license
Various supporting documents have to be prepared and submitted along with the license application. Each document has a crucial role in demonstrating compliance with regulatory guidelines. We have provided an overview of the documents required for securing CDSCO cardiovascular medical device license.
- Organization identity proof
- Sale Deed/Rent Deed of the Premises
- Plant Master File
- Device Master File
- Facility layout
- Documents for the team of qualified and experienced staff who can manufacture and test your medical devices.
- Test License, if required for testing the cardiovascular medical device
- Certificate of analysis of 3 consecutive batches
- ISO 13485 Certificate
- Environmental regulation compliance documents
By submitting these documents, the license applicant can demonstrate their cardiovascular medical devices meet stringent safety, performance, and quality requirements. For a detailed list of documents required, feel free to contact us. Additionally, we will help you prepare and compile the documents as per CDSCO guidelines. Our team has extensive expertise in document preparation for CDSCO medical device license application.
CDSCO cardiovascular medical device license application process: A simplified overview
The CDSCO medical device license application process involves the following steps:
- Applicant registration: Login/Signup on the CDSCO official online portal
- Document preparation: Compile all supporting necessary documents required for license application.
- Application submission: File the application online on the official CDSCO online portal. Ensure all details are accurate. Furthermore, properly attach all the documents.
- CDSCO query response: CDSCO may raise queries that have to be promptly and accurately addressed. The queries can range from clarification of the submitted documents to requests for additional information.
- Facility inspection: Prepare for the CDSCO medical device facility inspection and audit phase. CDSCO officials may visit the facility to ensure regulatory compliance.
- CDSCO license approval: The regulatory officials will verify all the documents and review the application. Then, if all the criteria are satisfied, the CDSCO will grant the license. This license will permit you to manufacture or import cardiovascular medical devices, as applicable.
Common CDSCO medical device license application challenges and how to overcome them
Manufacturers and importers might face the following challenges while applying for their CDSCO medical device license. Hence, we have provided some suggestions on how to tackle the challenges.
- Documentation Gaps: Ensure all the documents are up-to-date and have been prepared for CDSCO’s guidelines.
- Delays in CDSCO query resolution: Set up a dedicated team to address CDSCO queries promptly. CDSCO queries have to be promptly accurately addressed.
- Facility inspection setbacks: Regularly conduct internal reviews of the facility to identify any lapses and correct them prior to CDSCO inspections.
Validity of the CDSCO cardiovascular medical device license
The CDSCO cardiovascular medical device license is valid indefinitely. However, to maintain the validity, the license retention fee has to be paid every 5 years.
How can Pharmadocx Consultants assist you in securing the CDSCO cardiovascular medical devices license?
We at Pharmadocx Consultants are committed to make the CDSCO medical device licensing journey streamlined and efficient for our clients. We:
- Provide assistance throughout the CDSCO medical device licensing process.
- Conduct pre-inspection audits to identify lapses and provide corrective measures.
- Will help you promptly address CDSCO queries.
- Provide comprehensive support from the initial application to license approval. We will provide support till you successfully secure the CDSCO medical device license.
Need help securing the CDSCO cardiovascular medical device license? Drop an email at [email protected] or call/Whatsapp on 9996859227 and we will be more than happy to help.
