CURRENT AFFAIRS

Detailed explanation-1: -104(E) on 9th February 2022, which has further been finalized as “Medical Devices (Fifth Amendment) Rules, 2022”. The Fifth Amendment informs about the provisions related to the sale, exhibit, offer, or stock for sale or distribution of medical devices, including in-Vitro diagnostic medical devices in India.

Detailed explanation-2: -The draft Bill makes provisions for compensation to participants or their legal heirs for injury or death suffered in clinical trials and investigations for drugs and medical devices. There is a new provision for imprisonment, and fine amounting to double the compensation amount if the compensation is not paid.

Detailed explanation-3: -According to Rule 19J of the Medical Devices (Sixth Amendment) Rules, 2022, the Importer of Class A non-sterile and non-measuring medical device must submit the required information for medical device registration through an online portal.

Detailed explanation-4: -Non-Notified Class A and B medical devices will require an Import License by October 1, 2022 while Non-Notified Class C and D medical devices must have one by October 1, 2023. A full list of Notified product categories are found at the bottom of this page.