Government plans updates to accelerate medical device clearances

The government has introduced draft modifications to the 2017 Medical Devices Rules, aiming to streamline the approval process and hasten product availability. These updates address areas such as third-party sterilisation, standardized testing charges, and accepting EU standards to waive specific clinical investigation requirements. The goal of these changes is to cut down on administrative burdens, expenses, and wait times, while also increasing clarity for both those importing and manufacturing these devices.

by shortkt.com
3 hours ago
Government plans updates to accelerate medical device clearances | ShortKT