CDSCO Medical Device Registration for Pacemaker: Complete Guide

The DCGI issued a notice on July 26th 2021, stating the classification of medical devices pertaining to cardiovascular devices, per the provisions of medical device rules 2017. According to the classification, 36 non-notified devices be regulated as medical devices for the treatment of cardiovascular problems under the Medical Device Rules, 2017. The regulatory authorities have also mandated CDSCO Medical Device Registration for Pacemakers as a part of cardiovascular medical devices.

Overview of CDSCO Regulation on Medical Devices

Central Drug Standard Control Organization, or CDSCO, is the National Regulatory Authority of India and is responsible for regulating Medical Devices, IVDs and Drugs in India. It works under the Ministry of Health and Family Welfare, which the Directorate General of Health Services regulates under the Indian Government. CDSCO is also governed by the Drugs and Cosmetics act and is known as the Central Drug Authority of India.

A Medical Device may be any instrument, tool,  implement, machine, apparatus, appliance, implant, and reagent for in vitro use, material, software, or any other related article,” according to the definition provided by the FDA^[1].

A medical device can be one of two categories:

• Notified medical device
• Not Notified medical device

The Medical Device Rules, 2017, were brought into effect on January 1st 2018, by the CDSCO. The Central Drug Standard Control Organization (CDSCO) divided medical devices between India into four different classes- Class A, B, C and D. Under this classification, medical devices are categorized based on the risks involved. The different classes of devices involve different licensing procedures and requirements.

CDSCO Non-Notified Medical Device Classification

Earlier, only 37 medical devices were regulated by CDSCO. But in a recent notification, there has been a list of non-notified devices that falls under the definition of Medical Devices in India. The Ministry of Health and Family Welfare has recently amended the Medical Device Rules, 2017. According to a notice issued by CDSCO on February 11th 2020, it was notified that all medical devices are to be voluntarily registered with CDSCO before the deadline. After the deadline, registration will be made mandatory for those devices. The deadline for voluntarily registering medical devices of Class A and B is October 1st 2022, and for Medical devices of class C and D is October 1st 2023. 

CDSCO issued another notice on September 3rd 2020, which included 24 non-notified medical devices for registration. CDSCO Medical Device Registration for Pacemaker is classified under cardiovascular medical device, which is a part of the list. The classification of 24 newly listed non- notified devices are-

S.L. No.	Categories of medical device
1	Anaesthesiology
2	Pain Management
3	Cardiovascular
4	Dental
5	Ear, Nose, Throat (ENT)
6	Gastroenterological
7	Urological
8	General Hospital
9	Operation Theater (O.T.)
10	Respiratory

Classification of Cardiovascular Medical Devices

Cardiovascular medical devices are classified into various classes according to the intended use and risk classification. The CDSCO Medical Device Registration for Pacemaker has been made mandatory by CDSCO as different devices pacemakers have also been included in the classification, listed as follows-

Sr.No.	Medical Device Name	Risk Class
1	Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm)	C
2	Cardiac monitor (including cardio tachometer and rate alarm	B
3	Apexcardiograph (vibrocardiograph)	B
4	Echocardiography	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	The 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

Documents required for CDSCO Medical Device Registration for Pacemaker

The following is a list of the requirements for CDSCO Medical Device Registration for Pacemakers

• Application form for registration
• Challan TR6
• ISO 13485
• Power of Attorney
• An Undertaking stating that only accurate information is provided
• Certificate of quality assurance
• C.E. Design accreditation
• Declaration of conformity
• Schedule D(I)
• Master Plant File
• Device master file
• Free sale certificate

Procedure for CDSCO Medical Device Registration for Pacemaker

The process for CDSCO Medical Device Registration for Pacemakers in India is listed below. –

• Identify whether the medical devices need to be registered: To determine whether a medical device has been notified or not, the applicant must first check the Medical Devices and IVDs list. Before being marketed in India, all non- notified medical devices must obtain voluntary registration before the deadline.
• Indian Authorized Agent Appointment: In the case where the manufacturer is not Indian, an IAA, or Indian Authorized Agent, is appointed. The IAA represents the manufacturer in court and carries out all of their official business in India.
• Documentation procedure: To obtain a registration license, all required paperwork must be submitted to the appropriate authorities.
• Obtaining Registration and License: The manufacturer receives the registration license after submitting all required paperwork to the appropriate authorities.

Conclusion

Central Drug Standard Control Organization has issued a new risk-based Classification for Cardiovascular Medical Devices in India to comply with the latest medical equipment rules in India.CDSCO Medical Device Registration for Pacemakers is a part of the classification based on the cardiovascular medical device. The notice was issued on July 26th 2021, stating that Cardiovascular Medical Devices are classified as Non-Notified Medical Devices by CDSCO. The classification includes 24 medical devices. It is always advisable to connect with an experienced professional for CDSCO Registration for Medical Device Registration for Pacemaker to save time and money wasted on any failure.

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