Abstract

ADVANCEMENT IN REGULATORY FRAMEWORK FOR MEDICAL DEVICE REGULATIONS IN INDIA

Adhisha Mukherjee*

ABSTRACT

This Review Paper includes the various advancements in the regulatory framework of the Medical Devices Regulations In India so far. Various Laws, Rules and their amendments have been discussed in detail. The processes of medical Devices Development, Approval and Marketing are also studied. On February 11, 2020, two notifications were gazetted by the Government of India – (1) A new definition of Medical Devices. (2) The medical Devices (Amendment), 2020 These two notifications mainly referred that all medical devices will have to abide by the upgraded quality and safety regulations from the issue date of the notifications- 11 April, 2020. The standards of quality and safety of medical devices are being regulated by the Drugs and Cosmetics Act, 1940, popularly called the DCA. The scope of DCA has always been restricted to regulate only those devices which were notified by the Indian government as “Drugs”, known as Notified Medical Devices. The Medical Devices Rules, 2017, popularly called MDR, was framed under DCA with the objective to lay down comprehensive quality requirements which are to be strictly obeyed by the marketers, importers, manufacturers and sellers of the Notified Medical Devices. Until February 11, 2020, The Indian Government notified 37 categories of medical devices as DRUGS. After February 11, 2020, the government reinforced it’s powers to notify one or more categories of medical devices as “Drugs” and hence launched a new definition of Medical Devices.

Keywords: Medical Device Regulations, Medical Device Rules, 2017, MDR Amendments, Medical device development process, Approval process of registration and license of a medical devices, definition of Medical Device, Advancements in Laws, Drug and Cosmetics Act,1940