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CDSCO Certificate for Cardiovascular Medical Devices in India - Complete Registration & Compliance Services
A life-saving cardiac device is used to maintain the heartbeat, regulate blood circulation, or check on any heart problem. However, before being distributed to patients, there is a need to subject the devices to thorough tests and approvals.
Due to the rising need for advanced cardiac technologies in India, compliance has become an essential part that the manufacturer, importer, and distributor must take into consideration. Since there is an impact of these devices such as pacemakers, coronary stents, heart valves, and monitoring systems on the health of patients, therefore, their safety and reliability are of prime importance.
Regulatory-wise, getting the CDSCO certificate for Cardiovascular medical devices is very essential for all the companies manufacturing and distributing such devices in India.
CDSCO is an agency operating under the Directorate General of Health Services (DGHS), a regulatory body that functions under the Ministry of Health & Family Welfare, Government of India. CDSCO regulates Medical Devices as per the provisions of the Medical Devices Rules, 2017.
UMSPCS has also been successful in getting all the CDSCO registration for cardiovascular devices.
What Are Cardiovascular Medical Devices?
Cardiovascular medical devices refer to the devices where their primary use is aimed at diagnosing, monitoring, preventing, and treating heart disease.
There are many types of cardiovascular medical devices present in the market that help in curing various illnesses including coronary artery disease, heart arrhythmia, heart failure, and vascular diseases, among others.
Some of the examples of the most common medical devices for cardiovascular purposes regulated by CDSCO are:
- Cardiac pacemakers
- Coronary stents
- Angioplasty balloon catheters
- Heart valves
- ICDs
- Cardiac monitors
- Vascular grafts, and implantable devices.
What does CDSCO Certificate for Cardiovascular Medical Devices mean?
CDSCO certificate for cardiovascular medical device is a formal certificate issued by CDSCO for the permission of the firms in the field of cardiovascular medical device manufacturing, importing, selling, and distributing medical devices in India.
Medical devices are classified into different types according to the Medical Devices Rules, 2017, which are based on their use, risk and device class.
Manufacturers of cardiovascular devices have to comply with all the regulations prior to entering the Indian market.
Steps involved in the approval include:
- Classifying the device
- Evaluation of technical documents
- Safety/performance assessment
- Quality system verification
- Filing of the application through CDSCO’s portal
- Assessment of the regulatory filing by CDSCO
Without the approval, it will not be possible to market/distribute cardiovascular devices in India.
Classification of Cardiovascular Medical Devices
Medical devices are categorized depending on their risk class.
Class | Risk Level | Examples |
Class A | Low Risk | Basic monitoring devices |
Class B | Low Moderate Risk | Certain diagnostic devices |
Class C | Moderate High Risk | Cardiac monitoring equipment |
Class D | High Risk | Pacemakers, implants, heart valves |
Implantable cardiovascular devices are classified in high-risk categories owing to their potential effect on the health of humans.
CDSCO Updated Risk-Based Classification List
Pursuant to CDSCO Notice F. No. MED-16015(11)/1/2025-eoffice, the Central Licensing Authority regulates cardiovascular devices under a strict risk-based approach. Below is a comprehensive, updated list of representative cardiovascular medical devices, their intended uses, and their official risk classifications:
| S.No. | Device name | Intended use | Risk class |
| 1 | Active-implantable-device communicator | It is intended to communicate (e.g., via radio-frequency) with an active MR-conditional implantable device (e.g., a pulse generator) to receive information on device and/or physiologic performance, and/or to select and actuate MRI settings. | Class D |
| 2 | Aneroid manual sphygmomanometer | A device intended to measure blood pressure consisting of a manually inflatable cuff that fits around a limb (arm or thigh), an inflation bulb for controlling the air pressure within the cuff, an aneroid manometer, and tubing. | Class B |
| 3 | Aortic annuloplasty ring | A circular band intended to be implanted in the heart during open heart surgery to support an aortic valve annulus for the reconstruction and/or remodelling of an insufficient aortic valve. | Class D |
| 4 | Aortic bi-leaflet mechanical heart valve prosthesis | It is an artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. | Class D |
| 5 | Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft | An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). | Class D |
| 6 | Aortic heart valve bioprosthesis | A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. | Class D |
| 7 | Aortic transcatheter heart valve bioprosthesis, stent-like framework | An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed and/or regurgitant aortic heart valve, or previously-implanted aortic heart valve prosthesis, and which is designed to be implanted with a catheter via transarterial access (e.g., femoral, subclavian, aortic) or transapical access while the heart is beating. | Class D |
| 8 | Apexcardiograph (vibrocardiograph) | An apex cardiograph (vibrocardiograph) is a device used to amplify or condition the signal from an apex cardiographic transducer and to produce a visual display of the motion of the heart; this device also provides any excitation energy required by the transducer. | Class B |
| 9 | Apheresis Kit | Intended for the collection and separation of blood components | Class C |
| 10 | Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) | The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs. | Class C |
| 11 | Arterial cannula | Inserted into an artery, commonly the radial artery, and is used during major operations and in critical care areas to measure beat-to-beat blood pressure and to draw repeated blood samples. | Class D |
| 12 | Arterial catheter | Intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature. | Class D |
| 13 | Arteriovenous shunt | An implanted device intended to provide a passage for blood to flow between an artery typically located in an arm, and a peripheral vein, central vein or right atrium, creating a graft fistula that provides blood access for external procedures, especially haemodialysis. | Class D |
| 14 | Atherectomy coronary catheter | A catheter containing a rotating cutter a collecting chamber for debris, used for atherectomy and endarterectomy. | Class D |
| 15 | Atherectomy laser system beam guide-catheter, coronary | It is intended to be connected to an atherectomy laser system to invasively direct and deliver laser energy into the coronary arteries for the ablation of atherosclerotic plaques in completely occluded vessels. | Class D |
| 16 | Atherectomy peripheral catheter | Intended for use in atherectomy of the peripheral vasculature. | Class D |
| 17 | Automated external defibrillator, rechargeable/non-rechargeable | This electronic device is intended to automatically detect cardiac arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) in a sudden cardiac arrest (SCA) patient, after which it audibly/visually instructs an operator to enable it to activate defibrillation of the heart through application of electrical shocks to the chest surface. | Class C |
| 18 | Automatic-inflation electronic sphygmomanometer, professional use, non-portable | An electronic device intended to be used in indirect (noninvasive) measurement of blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. In addition to systolic and diastolic pressures, it also usually displays heart rate and mean arterial pressure. | Class B |
| 19 | Automatic-inflation electronic sphygmomanometer, professional use, portable | A portable device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures. | Class B |
| 20 | Ballistocardiograph cardiac output unit | A device used to record the body movement (toward the head and feet) caused by cardiac protrusion when blood is ejected by cardiac contraction. | Class B |
| 21 | Balloon dilatation vessel catheter | Intended for use in Percutaneous Transluminal Angioplasty (PTA) of the renal, tibial, popliteal, femoral and peroneal arteries. These catheters are not for use in coronary arteries. | Class B |
| 22 | Bare-metal coronary artery stent | A non-bioabsorbable stent intended to be implanted in a coronary artery or saphenous vein graft of the heart to maintain luminal patency and improve luminal diameter typically in a patient with symptomatic atherosclerotic heart disease. | Class D |
| 23 | Bifurcation stent | Intended for improving the side branch luminal diameter of arterial bifurcation liaisons. | Class D |
| 24 | Biventricular pacemaker | An MR conditional pulse generator, intended to be implanted in the chest and used with pacing leads placed in the and around the heart to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy. | Class D |
| 25 | Biventricular pacemaker/defibrillator | An MR conditional, implantable device intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)]. It enables conventional pacing and defibrillation functions also. | Class D |
| 26 | Cardiac ablation laser system beam guide-catheter | A steerable catheter intended to be used as part of a cardiac ablation laser system to invasively direct and deliver laser energy to the endocardium of a beating heart for the ablation of specific areas in the treatment of cardiac arrhythmias. It is intended to be introduced into the heart via venous access (e.g., femoral vein). | Class D |
| 27 | Cardiac ablation solid-state laser system | A device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a doped glass/crystal medium to emit a high-power laser beam intended for endocardial ablation procedures for the treatment of atrial fibrillation. A laser beam guide catheter and angioscope may be included | Class D |
| 28 | Cardiac ablation system applicator introducer/sizer | It is a flexible device intended to determine the appropriate size of a cardiac tissue ablation system applicator [to determine the appropriate number of transducers (ablation cells) required to treat the target tissue] and/or used to introduce and guide it into position, or used to help fix the applicator in position. | Class C |
| 29 | Cardiac ablation system irrigation tubing set | A set consisting of sterile flexible tubing and associated items that may include clamps, filters, and connectors, intended to deliver irrigation and/or cooling solution (saline) to an ablation device (e.g., an ablation catheter or a cardiac tissue ablation system applicator) at a specified flow rate during a cardiac electrophysiology (EP) ablation procedure. | Class B |
| 30 | Cardiac ablation thoracic motion sensor | A small electronic device intended to be placed on a patient’s chest during a cardiac ablation procedure to sense diaphragmatic movement as a means to assess potential phrenic nerve damage. | Class B |
| 31 | Cardiac arrest hypothermia kit | A collection of devices intended to lower the core body temperature of a patient in the short term following a cardiac arrest event to induce and sustain mild hypothermia for improvement of neurological and cognitive prognoses. It typically includes blankets, caps, axilla pads and groin pads, which are filled with a thermally-retentive material (e.g., non-toxic polymer gel) that can be cooled in a freezer. | Class B |
| 32 | Cardiac catheterization kit | 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. | Class C |
| 33 | Cardiac catheterization laboratory computer | A dedicated computer intended to calculate, store, and analyse haemodynamic parameters, and other cardiac-related measurements, based on data from catheterization laboratory monitoring/recording. Such data can be pressure measurements that are converted into useful parameters, e.g., cardiac output, pressure gradients, valve areas, shunt flows, vascular resistance, diastolic filling period or systolic ejection period. | Class C |
| 34 | Cardiac catheterization monitoring system | An assembly of devices intended to continuously obtain, amplify, and record various signals generated during procedures usually performed in the cardiac catheterization laboratory. The system is intended to be used for procedures such as left heart catheterization, right heart catheterization ventriculograms, coronary angiography, and pacemaker insertions; also used in procedures intended for the determination of most haemodynamic characteristics, evaluation of therapies, and planning of surgical approaches. | Class D |
| 35 | Cardiac cryosurgical system | A mobile assembly of mains electricity (AC-powered) devices intended to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. | Class D |
| 36 | Cardiac cryosurgical system catheter (Cardiac cryoablation balloon catheter) | It is intended to be used as part of a cardiac tissue cryosurgical system to cryogenically ablate areas of the endocardium of a beating heart in the treatment of cardiac arrhythmias. | Class D |
| 37 | Cardiac cryosurgical system remote control | A hand-operated electronic unit intended to control the operational functions of a cardiac cryosurgical system and its components (e.g., cardiac tissue ablation catheter) from a distance via a connected cable or wirelessly, during a surgical intervention. | Class C |
| 38 | Cardiac defect occluder | An implantable device intended to be used for the minimally-invasive closure of cardiac defects towards the treatment of cardiac disorders that may include (but not limited to) atrial septal defect (ASD), ventricular septal defect (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). | Class D |
| 39 | Cardiac electroacoustic transducer | A device intended to be used to detect the vibrations created by the heart's beating and which are transmitted through organs and tissue to the body surface. | Class B |
| 40 | Cardiac electrophysiology analysis system | An assembly of devices intended to perform several diagnostic tests and therapeutic treatments of the heart in patients with arrhythmic or conduction disorders, including analysis of the atrioventricular conduction system, defibrillator function, and/or the induction/termination of ventricular tachycardia. | Class C |
| 41 | Cardiac electrophysiology stimulation system | An assembly of devices intended to deliver precisely timed electrical impulses to the heart, during spontaneous and paced rhythms, for diagnostic cardiac stimulation. It is intended to be used for performing physiologic cardiac tests such as to determine the function of various components of the atrioventricular conduction, factors required for induction and termination of tachycardia, and/or to assess sinus node function. | Class C |
Eligibility Requirements for CDSCO Registration of Cardiovascular Devices
The firms that seek CDSCO Registration for Cardiovascular Devices need to satisfy some criteria.
For Indian manufacturers:
For foreign manufacturers:
Foreign manufacturers should have an authorized representative in India. The AIR will work as a bridge between the manufacturer and CDSCO authorities.
Foreign manufacturers should provide: Authorization for manufacturing Approval letters from the native country (in case they exist) Technical documents Quality certificates
Foreign manufacturers should provide:
Applicable Tests and Quality Requirements for Cardiovascular Devices
These cardiovascular devices need thorough testing to ensure their safety and effectiveness. Some examples of tests that can be conducted are:
- Biocompatibility Testing
- Sterility Testing
- Mechanical Testing
- Electrical Safety Testing
- Software Testing
CDSCO Registration Process for Cardiovascular Devices in India
The process of obtaining a CDSCO Certificate for Cardiovascular Medical Devices involves several steps.
Step 1: Registration of Applicants on CDSCO Sugam Portal
First of all, applicants have to register their companies and themselves on the CDSCO Sugam portal by providing basic information about the company and applicant to start the process of registration.
Step 2: Submit Application
Fill the relevant application form of CDSCO with necessary details pertaining to the cardiovascular device, manufacturing procedure, uses, and previous regulatory authorizations.
Step 3: Submission of Necessary Documents
Submission of all necessary documents such as technical specifications, Device Master File, Plant Master File, test results, quality certification and other relevant documents.
Step 4: Payment of Government Fees
Payment of CDSCO Government fees according to category of the device and its risk classification and importing from abroad or manufacture in India.
Step 5: Issuance of CDSCO Certificate
Approval of the certificate after examining all the application and documents where the device satisfies all safety standards and the issuance of certificate permits the legal manufacturing, importation, sale and distribution of cardiovascular medical devices.
Documents Required for CDSCO Certificate for Cardiovascular Medical Devices
Important documents are as follows:
- Form MD 40
- Challan TR6
- Power of Attorney
- Device Master File
- Covering Letter
- Plant Master File
- Quality Assurance Certificate
- Declaration of Conformity
- Covering Letter
- Certificate of Incorporation
- Approval Documents
CDSCO Registration Fees and Cost Factors
Factors contributing to the Cost of Getting a CDSCO Certification for Cardiovascular Medical Devices:
- Classification of Device
- Number of devices
- Import or Manufacturing Category
- Tests required
- Complexity of Documentation
- Consultancy Fees
Timeline for CDSCO Registration of Cardiovascular Devices
The review period varies based on the complexity of the device and documentation preparedness, and may take the following time periods:
- Low-risk devices: 3-6 months
- Higher risk implantable devices: 6-12 months or more
Possible reasons for delay are:
- Lack of documentation
- Request for additional information
- Delay in testing
- Regulatory questions
Benefits of CDSCO Registration for Cardiovascular Devices
1. Legal Market Access-A CDSCO certificate enables companies to trade and distribute cardiac devices within India.
2. Patient Safety Assurance-The registration guarantees that the devices are safe and meet the prescribed standards.
3. Increase in Customer Credibility-Medical devices with a certificate of approval have more credibility among hospitals, physicians, and healthcare providers.
4. Prevents Fines from Authorities-It reduces the probability of:
- Product recalls
- Limitation on market access
- Legal action
5. Facilitates Business Expansion-The approval facilitates the expansion of the company in the Indian healthcare industry.
Challenges in Obtaining CDSCO Approval
Businesses encounter challenges during the registration process because of the following reasons:
- Complex Documentation
- Difficulties in Device Classification
- Testings
- Regulatory Amendments
- Foreign Manufacturer Compliance
How UMSPCS Helps With CDSCO Registration for Cardiovascular Devices
UMSPCS offers complete CDSCO Consultant Services for Medical Devices to assist businesses with their registration process.
Having 6+ years of experience with 600+ product compliances, UMSPCS can help you obtain the regulatory approval of your device in an efficient manner.
Our services include:
- Assistance in product classification
- CDSCO regulatory consulting
- Documentation
- Technical files review
- CDSCO portal application
- Testings
- Licenses for manufacture
- Regulatory query handling
Conclusion
The medical devices used in cardiovascular cases have an influence on human beings and it is therefore necessary to ensure regulatory compliance before marketing in the Indian healthcare system.
Getting the CDSCO Certificate for Cardiovascular Medical Devices guarantees that your products conform to all the required safety and quality regulations in India.
Be it an Indian company or a foreign entity wishing to import cardiovascular medical devices in India, UMSPCS will help you out through CDSCO Registration for Cardiovascular Devices.
With our vast experience in handling 600+ product compliances, we offer efficient services in the approval process. Also can get more information about
Get in touch with UMSPCS today for professional CDSCO approval assistance
Frequently Asked Questions (FAQs)
Yes, it is mandatory for cardiovascular medical devices to obtain CDSCO approval for their manufacture, import, sales and distribution in India.
It is the regulatory certificate issued by CDSCO declaring the conformity of the device with the Indian safety and quality requirements.
Some of these devices include pacemaker, coronary stent, heart valve, angioplasty balloon catheter, defibrillator and cardiac monitors.
The time of the approval process depends on various factors but may take several months.
Yes, it is possible for foreign manufacturers to obtain CDSCO approval through an Authorized Indian Representative.
They are device Master File, Plant Master File, ISO 13485 certification, test reports, free sale certificate, and others.
It varies depending on many factors such as classification of the device, testing required, government costs, and documentation costs.
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