Medical Device – Modified Definition

On 11th February, 2020, the Ministry of Health and Family Welfare, Govt. of India published a gazette notification namely S.O. 648(E), which puts the definition of medical devices on par with the definitions of rest of the world. This notification is effective from 01st April 2020. You can go through the earlier definition here. In the earlier definition, the onus of determining whether a device is a medical device rests on the Govt. of India i.e. “Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act”. This particular part was now modified, and the same was provided below:

 “All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―

The central government has notified this under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act. Hence based on this generalized notification, similar to the definition of Drugs, the Central Government has no need to notify any further devices as medical device. The earlier responsibility of determining whether a particular device is a medical device has now shifted from the Central Government to the stakeholders i.e. manufacturer, importer, etc. This brings almost 2000 new devices, ranging from surgical masks to total artificial hearts, under the regulatory purview.

In order to provide the stakeholders adequate time for registration, the Medical Device Rules, 2017 was amended and now known as the Medical Devices (Amendment) Rules, 2020. These amended rules were effective from 01st April 2020. The salient feature was the addition of a new Chapter namely Chapter IIIA and modifications of the exemptions in Eight schedule. You can read more about the amended rules here.