The Medical Device Industry has been changed in various ways, as per the government policies, from the last two decades, such as Domestic driven to Import dependent, non-regulated to regulated devices, general classification to risk-based classification, under pharma domain to specific rules for medical devices at the licensing authority level. The new set of initiatives, such as Medical Device Rules 2017 & Materiovigilance, make the industry meet the global standards for medical devices. To make India self-reliant in every sector, the government encourages local manufacturers through various incentives to meet the demand in the Indian healthcare system.
The government has taken various steps to ensure that the medical devices sector is considered as significant as the other sectors. The new set of regulatory practices aims to remove the hurdles to prepare India to meet the Medical devices sector requirements. These new rules shall enhance the ease of doing business and ensure the availability of quality medical devices. Also, for the very first time, periodic renewal of licenses will not be required. Consequently, manufacturing and import licenses will be valid until it is suspended or cancelled. The rules also aim to promote a culture of self-compliance by manufacturers of medical devices. In addition, the manufacturing licenses for certain medical devices are granted without a prior audit of the manufacturing site. In such cases, the manufacturer has to do self-certification of compliance with the essential requirements and based on such certification, and the license will be issued.