CDSCO is the National Regulatory Authority of India, which operates under the Ministry of Health and Family Welfare, under the Directorate General of Health Services, Government of India, and is responsible for regulating Medical devices, IVDs and Drugs in India. It is the Central Drug Authority of India, and is regulated by Drugs and Cosmetics Act. It is responsible for regulating the import, manufacture and approval of new drugs and medical devices and conducts clinical trials and meetings of DTAB or Drugs Technical Advisory Board and DCC or Drugs Consultative Community. CDSCO is the Central Licensing Authority and is responsible for approving licenses for various drugs and medical devices. It also regulates CDSCO Medical Device Registration for Glucometer.
Glucometer as Medical Device
A glucometer is a portable tool used to measure the amount of glucose in the blood. Today, the amount of blood needed for measurement is somewhere around 0.5 µl to 3.0 µl. Standard glucose metres and continuous glucose monitors are the two kinds of glucose metres (CGMs).
Glucometers are basically made up of three parts-
- Glucometer: It is the brain of the system and is usually smaller than a cell phone. In this device, electric impulses are turned into levels of blood sugar. When the blood meets the enzyme on the test strip, electric impulses are made.
- Test strip: It is a thin, flexible strip of plastic that is around 0.5 to 1 inch long. They are made to soak up a small drop of blood so that the metre can read it. Between the top and bottom pieces of plastic are enzymes that change when a drop of blood is put on them. You can only use these strips once.
- Lancing Device: Lancing Device is a glucometer lancet; it is a pen-shaped device with a spring-loaded mechanism. It is used to poke holes in the skin to get blood.
Medical Device Regulation in India
The Government of India’s Ministry of Health and Family Welfare stated in a notification that the following medical devices would be considered drugs as of January 1, 2021. The devices are as follows:
3. Blood Pressure monitoring device
4. Electronic thermometer
All of these devices must be registered in compliance with the quality parameters outlined in the Medical Devices Rules of 2017 and other standards set by the Bureau of Indian Standards (BIS). The proposal to bring nebulisers, blood pressure monitors, digital thermometers, and glucometers under the preview of the Drug law was approved by the Drug Technical Advisory Body (DTAB), which is India’s highest drug advisory body. According to the notification, it is important to obtain CDSCO Medical Device Registration for Glucometer.
Risk Based Factors
The vast majority of medical devices are categorised according to the risks they have. The way in which a medical device is actually categorised according to the risks it poses is contingent on how and why it is used. The Different Classes of Medical Devices published by the CDSCO organises a more extensive assortment of medical tools, such as cannulas and stents, into subcategories with more granular designations.
Classification of Medical Devices Used in India:
There are several classification systems for in vitro diagnostic (IVD) and medical devices in India; each of these systems has four classes that are organised according to the level of risk posed by the respective devices. The following table lists four categories of medical equipment manufactured in India:
|Medical device class||Risk level|
|Class-B||Low-Moderate level risk|
|Class-C||Moderate-High level risk|
In accordance with the New Medical Rules that came into effect in 2017, the various Classes of Medical Devices have been separated into a total of four categories. Any business that intends to manufacture such products for the purpose of distribution or sale is required to make an application to the CDSCO for a manufacturer’s licence.
Regulatory Authorities for CDSCO registration
Regulatory authorities for registration CDSCO Medical Device Registration for Glucometer are-
- Central Drugs Standards Control Organization– It is the primary regulatory body in India that is responsible for regulating pharmaceuticals and medical devices. It is part of the Directorate General of Health Services, which is part of the Ministry of Health and Family Welfare.
- Drug Controller General of India (DCGI) – This position serves as the head of CDSCO and is accountable for the regulation of clinical trials as well as the approval of high-quality drugs and cosmetics that are intended for sale in India.
- The Drugs and Cosmetic Act and Rules– In India, the Manufacture, Import, and Distribution of Drugs are all governed by a set of rules known as the Drugs and Cosmetic Act and Rules.
Checklist for CDSCO Medical Device Registration for Glucometer
Following is the checklist for CDSCO Medical Device Registration for Glucometer:
- Application Form
- ISO 13485 Certificate
- TR6 Challan
- Power of attorney
- Undertaking that only authentic details are provided
- Full quality assurance certificate
- CE Design certificate
- Declaration of conformity
- Schedule D(I)
- Device master file
- Plant master report
- Free sale certificate
Procedure for CDSCO Medical Device Registration for Glucometer
There were no rules/regulations in place for the sale of medical devices in India’s market prior to 2006. Later, CDSCO made a rule that all medical devices on the market must meet CDSCO’s standards. Because of the compliances, Medical Devices had to be registered with CDSCO before they could be made, sold, or brought into the Indian market. Here are the steps you need to take to get CDSCO Medical Device Registration for Glucometer.
1. Determine if Medical Devices are required to be registered- First, the applicant must look at the list of Medical Devices & IVDs to see if the medical device has been notified. All medical devices that are notified must be registered before they can be sold in India. In this case, the glucometer is a “notified device” that needs to be registered with CDSCO.
2. Risk-Based Classification of Medical Devices- Based on the risks associated with each of the notified devices that must be registered with CDSCO, they are separated into different categories. The Glucometer is in Class C of the risk-based classification of medical devices because it has a medium level of risk.
3. Appointment of Indian Authorized Agent- If the manufacturer is not an Indian, an IAA, or Indian Authorized Agent, has been chosen. The IAA is the manufacturer’s legal representative, and it does all of the manufacturer’s official work in India.
4. Documentation Process– To get a registration licence, you have to give the right authorities all the documents they need.
5. Receiving Registration and License- The registration licence is given to the manufacturer after all the necessary paperwork has been sent to the right people.
Timeline for CDSCO Medical Device Registration for Glucometer
The CDSCO Medical Device Registration for the Glucometer takes between six and nine months to finish after the application is turned in. The registration is still valid for three years after it is made. If the registration needs to be renewed, the renewal application must be submitted six months before the registration expires.
The Glucometer is a Class-C medical device; therefore, it is mandatory to register the device with CDSCO. Even the slightest mistake during the registration process could cause the application to be turned down. So, it’s always best to get help from a professional for CDSCO Medical Device registration for Glucometer.
Read our Article:CDSCO Medical Device Registration for Digital Thermometer