The Ministry of Health and Family Welfare (‘MOHFW’), by way of two notifications, dated February 11, 2020, made sweeping changes to the regulatory scheme applicable to medical devices in India.

By way of the first notification (‘First Notification’), the MOHFW has brought all medical devices under its regulatory ambit by notifying such medical devices under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 (‘DCA’). The First Notification will be effective from April 1, 2020.

Set out below is the specific language used in the First Notification (and in the amended Section 3(b)(iv) of the DCA), pursuant to which, now, a medical device is/includes:

‘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 an pharmacological or immunological or metabolic means, but which may assist in its intended by function, by such means for one or more of the specific purposes of –

i.        Diagnosis, prevention, monitoring, treatment, alleviation of any disease or disorder;
ii.      Diagnosis, monitoring, treatment, alleviation, or assistance for any injury or disability;
iii.     Investigation, replacement, or modification or support of the anatomy or of a physiological process;
iv.      Supporting or sustaining life;
v.       Disinfection of medical devices;
vi.     And control of conception’

hereinafter referred to as (‘Newly Notified Medical Devices’).

Consequently, as per Rule 2 of the Medical Devices Rules, 2017 (‘MDR’), the provisions of the MDR will be applicable to all such Newly Notified Medical Devices.

By way of the second notification dated February 11, 2020 (‘Second Notification’), the MOHFW has inserted Chapter III-A titled ‘Registration of Certain Medical Devices’ in the MDR. The Second Notification will also be effective from April 1, 2020. This newly added chapter will be applicable to all devices notified under clause (b) of Section 3 of the DCA (which includes the Newly Notified Medical Devices). However, this Chapter will not be applicable to the medical devices specified in the Annexure of the Eighth Schedule to the MDR (i.e., those medical devices which have already been notified prior to April 1, 2020).

Pursuant to the Second Notification, Newly Notified Medical Devices will have to be registered (registration will include providing details such as the name of the device, model number, dimension, etc.) with the Central Drugs Standard Control Organization (‘CDSCO’) through an identified online portal. Such registration will be voluntary for a period of 18 months (from April 1, 2020). Although the registration of such Newly Notified Medical Devices is voluntary (for a period of 18 months from the effective date of the First Notification), if one does not register, the manufacturers and importers of the Newly Notified Medical Devices will not be able to avail themselves of the exemptions (as detailed below).

From April 1, 2020, the Newly Notified Medical Devices will be regulated by the MDR and persons/companies who manufacture and import such devices will be required to apply for the requisite licenses. However, Rule 3 of the Second Notification exempts the Newly Notified Medical Devices from the purview of the MDR, for a limited time frame. Such time frame is a period of 30 months (from April 1, 2020) for Class A and Class B medical devices (i.e., low risk and low moderate risk devices), and a period of 42 months for Class C and Class D medical devices (i.e., moderate high risk and high risk devices) (‘Exemption Time Periods’). Once the respective exemption periods are over, the Newly Notified Medical Devices will be regulated as per the provisions of the MDR. In order to avail benefits of the Exemption Time Periods, the manufacturers and importers of the Newly Notified Medical Devices will have to get such devices registered with the CDSCO.