The Government of India is revamping the existing regulations on medical devices to be at par with the global norms and standards, to have a better control over their manufacture, import and sale. A new notification was released by the Drugs Controller General of India (DCGI) in Nov 2018 regarding […]
The Government of India is revamping the existing regulations on medical devices to be at par with the global norms and standards, to have a better control over their manufacture, import and sale.
A new notification was released by the Drugs Controller General of India (DCGI) in Nov 2018 regarding certain medical devices, which will now be regulated devices, starting January 2020. Earlier, these medical devices were not regulated and thus, did not need registration before being sold in the Indian market. The following devices have now been classified as regulated devices:
Nebulizer1: This is a class B (low-to-moderate risk class) medical device, which sprays liquids in aerosol form. This directly delivers the drug deep into the respiratory system with minimal losses into the environment and helps in stabilizing breathing. It is frequently prescribed with therapy for chronic pulmonary obstructive disease. It includes the following types:
BP machine2
It is used to detect blood pressure and comes under the category of devices that are not classified in any class, thus assigned to class A (low risk) medical devices as it does not come in contact with the individual or comes in contact with the skin surface only.
Digital thermometer2
It is used to detect body temperature. It comes under the category of devices that are not classified in any class, thus assigned to class A (low risk) medical devices, as they are intended for transient use without any connection to any other medical devices or as it is to be connected with medical devices of class A only.
Glucometer1
This device comes under class B (low-to-moderate risk class) medical device and aids in detecting glucose levels in the blood.
Application for the 1) import of medical devices; 2) manufacturing for the purpose of sale or distribution of medical devices; 3) the sale, stock, exhibit or offer for the sale of medical devices; 4) in vitro diagnostic kits
The technological changes and development in the branch of medical devices have been grouped as per the recent standards issued by the Ministry of Health and Family Welfare, Government of India.
The manufacturer of these products shall follow the safety and efficacy principles laid down in the guidelines.
The products shall conform to the guidelines set in place by the Bureau of Indian Standards Act, 1985, or as per the norms put forth by the Ministry of Health and Family Welfare.
In the case of class B devices, the place of manufacture shall conform to the quality requirements stated under the fifth schedule. It should also be verified for compliance by a notified body before the grant of license.
Any organization aiming to manufacture devices for sale or distribution shall abide by the norms prescribed in the guidelines and follow the registration steps listed above.
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