The Central Drug Standard Control Organization (CDSCO) is the national regulatory body of India. The Ministry of Health & Family Welfare, Government of India, oversees it through the Directorate General of Health Services. It is governed and regulated by the Drugs and Cosmetics Act and is responsible for the approval of drugs, setting their standards, conducting clinical trials, checking the quality of imported drugs, etc. In order to comply with the standards set by Medical Device Rules 2017, the Ministry of Consumer Affairs had made a proposal for CDSCO Medical Device Registration for Defibrillators,
Defibrillators as Medical Device
Defibrillators are devices that are used to send an electric shock or pulse to the heart for restoring the normal heartbeat. This device is used to correct arrhythmia- abnormal heartbeats which are either too slow or too fast. If in case the heart suddenly stops working, defibrillators are used to make the heart start beating.
There are three types of defibrillators-
- Automated External Defibrillators (AEDs)
- Implantable Cardioverter Defibrillators (ICDs)
- Wearable Cardioverter Defibrillators (WCDs)
Medical Device Regulation in India
In India, the market for Medical Devices is a significant and important part of the healthcare sector, especially for the purpose of preventing, diagnosing, treating, and managing several ailments, impairments, diseases and Illnesses. It is a support system for the Indian healthcare unit and helps in performing important functions, which are stated in the National Health Policy (NHP) 2017. The Medical device regulation helps in providing good quality, affordable and all-encompassing healthcare services in India.
Directorate General of Health Services (DGHS) had issued a notification 648 (E) published in The Official Gazette of India. The notification stated that the following criteria of medical devices would be considered as Drugs, effective from 1st April 2020-
“All the devices that are Instrument, appliance, apparatus, material, implant or any other tool, which is used either alone/in combination with other device, software or accessory and Is used specifically for humans and animals, which do not achieve the primary intended action in or on animal or human body by any pharmacological or Immunological or metabolic means, but which may help in its intended function by such means for one or more specific purpose of-”
- Diagnosis, monitoring, prevention, alleviation or treatment of any disorder or disease
- Diagnosis, monitoring, treatment or alleviation of any disability or Injury
- Replacement, investigation, support or modification of a physiological process or of the anatomy
- Life support and sustaining
- Medical Device disinfection
- Conception control
According to the notification, the intended use of the Defibrillator is to send an electric shock or pulse to the heart for restoring the normal heartbeat. The risk classification of the device is Medium-High level risk, which makes it mandatory for the device to be registered with CDSCO.
Classification of Medical Devices in Medical Device Rules, 2017
According to the Medical Device Rules 2017, the DCGI, who is the head of CDSCO, is responsible for regulating the different classes of Medical Devices as per their Risk-based classification. CDSCO has set up different classes of medical devices as per the level of risk associated with each device. Medical Devices are categorized into four types on the basis of Risk-Based classification, which are as follows-
Class A, Class B, Class C & Class D Medical devices.
The level of danger associated with each device increases with the increase in the Classes of Medical devices. The following table lists the classification of medical devices on the basis of the risk involved-
|Device Class||Risk Involved|
|Class A Medical Devices||Low Risk|
|Class B Medical Devices||Low-Medium Risk|
|Class C Medical Devices||Medium-High Risk|
|Class D Medical Devices||High Risk|
Regulatory Authorities of Defibrillators as Class C Medical Devices in India
The Authorities who are responsible for regulating the CDSCO Medical Device Registration for Defibrillators in India are-
- Central Drug Standards Control Organization (CDSCO)
- Drug Controller General of India ( DCGI)
- Drugs & Cosmetic Act 1940 & Rules 1945
Documents Required for CDSCO Medical Device Registration for Defibrillators
Following are some vital documents required for CDSCO Medical Device Registration for Defibrillators:
- Application Form (Form-40)
- ISO 13485 Certificate
- TR6 Challan
- Undertaking that only authentic details are provided
- Power of attorney
- Full quality assurance certificate
- CE Design certificate
- Schedule D(I)
- Declaration of conformity
- Device master file
- Free sale certificate
- Plant master report
- Free Sale Certificate/ Certificate from the Foreign Government
Procedure for CDSCO Medical Device Registration for Defibrillators
Before 2006, Medical Devices did not have any regulations and were marketed in India without any law governing them. In the years after 2006, the CDSCO enacted a regulation which required all Medical Devices which are Manufactured, Imported or sold in the market to be registered with CDSCO first. The procedure for CDSCO Medical Device registration for Defibrillators is-
- Determine whether the Medical Devices require registration or not: The first step is to check with the Medical Devices and IVDs list to check if the medical device is notified or not. All the notified medical devices are required to obtain registration before they are marketed in India. Defibrillators must be registered as medical devices under CDSCO and are notified devices.
- Risk Based Classification of Medical Devices: The notified devices which are required to be registered with CDSCO are then identified on the basis of risks involved with them. Defibrillators are classified as Class C medical devices because of Medium- High level risk involved with them.
- Appointment of Indian Authorized Agent (IAA): An Indian Authorized Agent is appointed in case if the manufacturer is not an Indian. The IAA acts as a representative on behalf of the manufacturer to conduct all his official duties in India.
- Technical Documentation: All the necessary documents are required to be submitted to the respective authorities in order to obtain a Registration License.
- Obtain Registration and License: After all the necessary documents are submitted to the correct authorities, the registration license is obtained by the manufacturer.
Timeline for CDSCO Medical Device Registration for Defibrillators
The timeline for CDSCO Medical Device Registration for Defibrillators is 6-9 months after the application process is completed. The Medical Device registration is valid for three years. In order to renew the registration, the applications are required to be submitted six months before the date of expiry.
The Global market for Defibrillators was calculated at US$ 11.4 billion in 2021 and is expected to reach US$ 18.2 billion by 2026. There has definitely been significant market growth in the medical device industry because of various factors. Since Defibrillators fall in the category of Class C Medical devices, there is a mandatory requirement for registration. However, the slightest error in the registration process may cause the rejection of the application. Therefore, it is always advisable to get professional help for the purpose of CDSCO Medical Device Registration for Defibrillators.
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