Parliament’s Health Committee has recommended an amendment to the Therapeutic Products Bill to distinguish between software as a medical device (SaMD) and software in a medical device (SiMD).

The Bill creates a new regulatory regime for SaMD with software covered by the scheme becoming subject to a new regulator and market authorisation regime. This means they would need authorisation before their product can be imported, supplied in, or exported from New Zealand, as well as a robust surveillance and response system for their products.

Article published by HiNZ. To read the full article go to the HiNZ website >