CDSCO Medical Device Registration for Digital Thermometer – An Overview

 

Central Drug Standard Control Organization, or CDSCO, is the National Regulatory Authority of India and is responsible for the regulation of Medical Devices, IVDs and Drugs in India. It works under the Ministry of Health and Family Welfare, which is regulated by the Directorate General of Health Services under the Indian Government. CDSCO is also governed by the Drugs and Cosmetics act and is known as the Central Drug Authority of India. It keeps a check on the import, manufacturing and marketing of new drugs, medical devices, IVDs and Drug related products in India and has the authority to provide licenses, because of which it is also called the Central Licensing Authority. It provides licenses for the registration, import and manufacture of medical devices and IVDs. The CDSCO Medical Device Registration for Digital Thermometers is also governed by it. CDSCO also conducts clinical trials of drugs and conducts meetings of the Drugs Consultative Community and Drugs Technical Advisory Board.

Digital Thermometer as Medical Device

Digital thermometers are instruments that are used to sense temperature and are easily portable, and have permanent probes, along with a convenient digital display. The way a digital thermometer work is dependent upon its type of sensor.

Sensors of digital thermometer include-

• Resistance Temperature Detector (RTD)
• Thermocouple
• Thermistor

 

Important specifications for digital thermometers include-

• Display Options
• User interface
• Outputs
• Operating environment

 

Applications for Digital Thermometers

Following are the applications for Digital Thermometers :

• Medicinal uses- Digital thermometers are often used in clinical settings on patients.
• HVAC thermometers– HVAC thermometers are used for applications such as duct or flume monitoring.
• Sanitary uses- Thermometers are used for sanitary purposes such as food or pharmaceutical applications.
• Home use- Home uses include digital thermometers used for home health care, cooking & monitoring temperature on home appliances such as the refrigerator/swimming pool.
• Laboratory uses- Laboratory uses includes monitoring experiments and chemical reactions as well as maintaining an optimal laboratory environment.
• Food Service- Thermometers in identifying completeness of cooking and sanitation of ingredients.
• Meteorological thermometers- Thermometers are also used to give air, atmosphere and water temperature readings.

 

Medical Device Regulation in India

As of January 1, 2021, the following devices must be regarded as drugs, according to a notification from the Government of India’s Ministry of Health and Family Welfare. The devices are as follows-

• Digital thermometer
• Glucometer
• Nebuliser
• Blood pressure monitor

 

All of these devices will need to be registered in accordance with the quality requirements outlined in the Medical Devices Rules of 2017[1] and other standards established by the Bureau of Indian Standards (BIS) accreditation.

The proposal to bring nebulisers, blood pressure monitors, digital thermometers, and glucometers under the purview of the Drug law was approved by the Drug Technical Advisory Body (DTAB), the highest drug advisory body in India.

Risk Based Factors

Most medical devices are categorised according to the risks involved. Depending on how and why it is used, a medical device may actually be categorised according to its risks. A larger group of medical devices, such as cannulas and stents, are divided into smaller groups with more precise names according to CDSCO’s Different Classes of Medical Devices.

In India, there are four medical device classification systems, and each of these systems has four classes according to their risk classification. There are four different types of Indian medical devices listed in the table below-

 

Medical device class	Risk Associated
Class-A medical device	Low risk
Class-B medical device	Low-Moderate risk
Class-C medical device	Moderate-High risk
Class-D medical device	High risk

 

According to the New Medical Rules of 2017, various classes of medical devices have been divided into four distinct categories. A, B, C, and D Classes. Any business that intends to produce such devices for distribution or sale must apply for a manufacturer’s licence from CDSCO.

Regulatory Authorities for CDSCO Registration

The following are the regulatory bodies for CDSCO Medical Device Registration for Digital Thermometer :

• Central Drug Standard Control Organization (CDSCO) : It is India’s primary regulatory body for pharmaceuticals and medical devices, falling under the Ministry of Health and Family Welfare’s Directorate General of Health Services.
• Drug Controller General of India (DCGI) : It is the head of CDSCO and is in charge of overseeing clinical trials and approving high-quality medications and cosmetics for national distribution.
• The Drugs and Cosmetic Act and Rules : In India, the manufacture, import, and distribution of drugs are all governed by the Drugs & Cosmetic Act and Rules.

 

Checklist for CDSCO Medical Device Registration for Digital Thermometer

Following is the checklist for CDSCO Medical Device Registration for Digital Thermometer :

• 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 Digital thermometer

Prior to 2006, there were no laws or regulations governing the sale or use of medical devices in India. Later, CDSCO issued a regulation requiring all medical devices sold on the market to be in compliance with CDSCO. Medical Devices must now be registered with CDSCO before being manufactured, sold, or imported into the Indian market due to compliance requirements. The steps to take for CDSCO Medical Device Registration for a BP monitor in India are listed below:

• Verify whether the registration of the medical devices is necessary : The applicant must first check the Medical Devices and IVDs list to determine whether the medical device has been notified. Before being marketed in India, all medical devices that have been notified are required to register. In this scenario, the digital thermometer belongs to the group of notified devices and needs to be registered with CDSCO.
• Risk-Based Classification of Medical Devices : Depending on the risks associated with each device, the notified ones that must be registered with CDSCO are then determined. A digital thermometer involves a Medium level of risk, placing it in Class B of the risk-based classification of medical devices.
• Appointment of Indian Authorized Agent : In the event that the manufacturer is not an Indian, an IAA, or Indian Authorized Agent, has been named. The IAA, who serves as the manufacturer’s official representative in court, carries out all of his business in India.
• Documentation Process : To obtain a registration licence, all required paperwork must be submitted to the appropriate authorities.
• Receiving Registration and License : After submitting all required documents to the appropriate authorities, the manufacturer receives the registration licence.

 

Timeline for CDSCO Medical Device Registration for Digital Thermometer

After submitting the application, the CDSCO Medical Device Registration for Digital Thermometers typically takes six to nine months to complete. Three years are allowed for registration to be valid. If the registration needs to be renewed, the renewal application must be submitted six months before the current registration expires.

Conclusion

Digital thermometers are temperature-measuring tools with permanent probes and a digital display that makes them easy to carry around. Medical Devices are required to be registered with CDSCO before being marketed in India, in accordance with the Medical Devices Rules of 2017, which makes CDSCO Medical Device Registration for Digital Thermometer mandatory. Although, Even a slight registration application error can result in the application being rejected. In light of this, it is always advisable to seek professional assistance with CDSCO Medical Device Registration for Digital Thermometer.