The Union health and family welfare ministry has amended the Medical Devices Rules, 2017, eliminating the need for a separate loan license for manufacturers who outsource the sterilization of their products. This change aims to promote ease of doing business, simplify regulatory processes, and enhance transparency in the medical device sector.
It added that the amendment to Rule 44 was finalised after extensive stakeholder consultations to simplify regulatory compliance for medical device manufacturers availing outsourced sterilisation facilities.
“The amendment eliminates the requirement for a separate loan licensing process in such cases, thereby reducing duplication, administrative burden, compliance costs and associated timelines, particularly for manufacturers that do not have in-house sterilization facilities,” said the statement. The ministry said the reforms are expected to reduce costs and facilitate the timely availability of advanced and innovative medical devices. “The measures represent an important step towards strengthening the medical device regulatory ecosystem and promoting greater Ease of Doing Business, while continuing to maintain robust standards of quality, safety and performance of medical devices.”
