The medical device industry in India is predicted to expand over the next several years as a result of greater health awareness, a growing middle-class population, and government health programmes. With the release of the Medical Device Rules in 2017, Indian authorities completely altered the medical device regulatory procedure. The Central Drugs Standard Control Organisation, also called CDSCO, is a National Regulatory Authority of India. It comes under the preview of the Directorate General of Health Services (DGHS) under the Ministry of Health & Family Welfare. Additionally, CDSCO and state regulators are jointly in charge of issuing licences for certain specialized categories of drugs, including vaccines, blood and blood products, IV fluids, and sera. In this article, we will discuss CDSCO Registration for Cardiovascular Medical Devices.
Every year, cardiovascular medical devices such as artificial heart valves, coronary stents, endovascular grafts, and angioplasty balloon catheters save thousands of lives. The use of these devices helps to identify and treat heart disease and other related health issues. However, for device manufacturers, designing, developing, and producing new implantable cardiovascular devices is a challenging, time-consuming, and expensive process.
Prior to 2005, India had no regulations governing medical devices. Today, however, there are registration processes for specific medical device types that are covered by the Medical Device Rules. While the list of regulated products is exhaustive, the CDSCO occasionally adds products to the list. Before marketing your product in India, you must first ascertain whether it is governed by the CDSCO.
Regulatory Compliance for Cardiovascular Medical Devices
The term medical devices are mentioned under Section 3 (b) (iv) of the Drugs & Cosmetics Act. Medical devices are classified into four different risk classes, namely Class A, Class B, Class C & Class D. Recently, CDSCO issued a clarification on cardiovascular medical devices classification. As per the notice dated: July 26, 2021, DGI issued a list of classification of medical devices pertaining to cardiovascular under the provision of the Medical Devices rule, 2017.
Cardiovascular devices are classified into a number of classes as per intended use and the risk associated with them. Pacemakers and other cardiovascular medical devices now require CDSCO Medical Device Registration. To register the pacemaker or other cardiovascular devices, manufacturers need to classify their devices first and then need to submit the list of necessary documents to the respective department. If a manufacturer is not Indian, then he/she needs to appoint IAA Indian authorized agent who represents the manufacturer and carries business in India.
- Classification Of Medical Devices Pertaining To Cardiovascular
Mentioned below is the list of all the medical devices pertaining to cardiovascular with their risk category;
| Medical Device Name | Risk Class |
| Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) | C |
| Cardiac monitor (including cardiotachometer and rate alarm) | B |
| Apexcardiograph (vibrocardiograph) | B |
| Echocardiography | B |
| Electrocardiograph | B |
| Electrocardiograph electrode | B |
| Vascular clip | B |
| Vena cava clip | B |
| Intra-aortic balloon | C |
| Intra-aortic balloon control system (balloon pump) | B |
| Ventricular bypass (assist) device | D |
| Pacing system analyzer | C |
| An implantable pacemaker pulse generator | D |
| Pacemaker lead adaptor | C |
| Pacemaker generator function analyzer | C |
| Cardiovascular permanent or temporary pacemaker electrode | C |
| Pacemaker test magnet | A |
| Pacemaker programmers | C |
| Pacemaker repair or replacement material | D |
| Annuloplasty ring | C |
| Carotid sinus nerve stimulator | D |
| Replacement heart valve | D |
| Endomyocardial biopsy device | D |
| Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure | C |
| Cardiopulmonary bypass bubble detector | B |
| Cardiopulmonary bypass vascular catheter, cannula, or tubing | B |
| Cardiopulmonary bypass heart-lung machine console | B |
| Cardiopulmonary bypass defoam | C |
| Cardiopulmonary bypass heat exchanger | B |
| Cardiopulmonary bypass temperature controller | B |
| Cardiopulmonary bypass arterial line blood filter | C |
| Cardiopulmonary bypass cardiotomy suction line blood | B |
| Cardiopulmonary bypass pulsatile flow generator | D |
| Intraluminal artery stripper | B |
| External cardiac compressor | C |
| External transcutaneous cardiac pacemaker | C |
What Documents Are Required For CDSCO Registration For Cardiovascular Medical Devices?
Following is the exhaustive list of documents needed for CDSCO registration for cardiovascular medical devices:
- Application form for registration
- Challan TR6;
- ISO 13485;
- Power of Attorney;
- An Undertaking stating that only accurate information or details are provided;
- Certificate of quality assurance;
- C.E. Design Accreditation;
- Declaration of Conformity;
- Schedule D(I);
- Master Plant File or MPF;
- Device Master File or DMF;
- Free Sale Certificate (FSC);
Procedure for CDSCO Registration for Cardiovascular Medical Devices
Applications for both notified and non-notified medical devices must be filed via the online SUGAM portal, which is also used by CDSCO to manage applications.
Previously, manufacturers were allowed to sell medical devices in India without being subject to any regulations. Since 2006, the CDSCO’s Indian Medical Device Regulations have applied to medical devices entering the Indian market.
Mentioned below is a step-by-step process for CDSCO registration for cardiovascular medical devices:
- The 1st step is to determine whether your product requires registration.
- Appoint an authorized Indian agent:
- A manufacturer can appoint an authorized Indian agent for CDSCO registration for cardiovascular medical devices.
Eligibility to be an authorized Indian agent for CDSCO Registration for Cardiovascular Medical Devices:
- Must be a Resident of India
- Must have years of experience in the healthcare industry
- Must hold Power of Attorney to submit Medical Device Registration documents to CDSCO
- Must hold wholesale drug licenses in forms 20B and 21B.
- Submit the duly-filled application form along with the required documents.
- Obtain a registration certificate.
- After the documents for CDSCO Registration for Cardiovascular Medical Devices are submitted, CDSCO will get back to the Indian Agent (Authorised Representative) with a query letter (if any). If the responses or replies given by the agent are satisfactory to the CDSCO, the licence will be granted.
- The certificate for CDSCO Registration for Cardiovascular Medical Devices is valid for a term of three years.
Following forms are used for CDSCO Registration for Cardiovascular Medical Devices in India:
| Type of Applicant | Class of Medical Device | Application Form | License Form |
| Manufacturer | A,B | MD-3 | MD-5 |
| Importer | A,B,C,D | MD-14 | MD-15 |
| Manufacturer (Loan License) | A,B | MD-4 | MD-6 |
| Manufacturer | C,D | MD-7 | MD-9 |
| Manufacturer (Loan License) | C,D | MD-8 | MD-10 |
Conclusion
Medical devices are a vital component of healthcare, yet they are a remarkably diverse class of goods. They can be broadly categorized as preventative care devices, assistive care devices, diagnostic devices, and therapeutic devices based on their functions. The Indian medical device industry is Asia’s fourth-largest market.
According to the terms of the Medical Device Rules, 2017[1], enacted by the government under the Drugs and Cosmetics Act, 1940, medical devices are regulated as drugs in India by the Central Drugs Standards Control Organization (CDSCO). Only the devices that the government has notified are governed and fall within the MDR17 regulations. The 2017 Rules adopted a risk-based classification approach for medical device regulation, with Low Risk (Class A), Low Moderate (Class B), Moderate High (Class C), and High-Risk devices classed as (Class D).
Read Our Article: CDSCO Medical Device Registration For Pacemaker: Complete Guide
