Current Scenario of Medical Device in India

The fact that India relies on medical device imports (approximately 75–80% of revenues are produced by imported medical devices) to supply its healthcare system shows that international corporations now control the medical device business in India.

Medical devices that are ‘investigational devices’ and subject to additional clinical investigation requirements and review, including establishing safety and effectiveness through clinical investigation in India, are novel to the Indian market in terms of materials, mode of action, or intended use. Depending on the level of risk, medical devices are divided into 4 categories: A, B, C, and D. The device classification determines the CDSCO fees for application processing. No matter how the gadget is classified, the application procedure takes 6 to 9 months. Applications for goods that are unable to recognize a predicate device will be deemed “Innovative” and probably take more time.

Medical devices can be broadly categorized as preventative care devices, assistive care devices, diagnostic devices, and therapeutic devices. Perhaps these particular difficulties—such as product diversity, safety concerns, and the sheer variety of devices on the market—are what make creating an effective and efficient regulatory framework a difficult task for both domestic and international regulatory authorities. Governments and regulators rely on standards to create better regulation.

Since April 1, 2020, all medical devices must be registered under the 1940 Drugs and Cosmetics Act in order to maintain their status as one of the 23 previously notified medical devices. All Class A and B medical devices must have import licenses before being imported as of October 1, 2022. By October 1, 2023, all Class C and D gadgets that haven’t already been notified must obtain import licenses. Even though import licenses are not currently necessary for medical equipment, owners must nonetheless register their product(s) through an ePortal within a few days.