What is a hospital medical device?
Medical devices are defined under legislation by the Ministry of Health and regulated by Medsafe
What devices will Pharmac consider?
We have a broad range of products that we think could be listed on the Pharmaceutical Schedule for hospitals. These devices could:
- be used in a public health setting or part of a clinically driven pathway
- be used to diagnose, monitor, treat, modify, prevent or support health requirements
- maintain or improve health and/or safety for all people in the context of the NZ healthcare environment
- be part of an integrated system that supports the clinical environment
This includes a vast array of products from tongue depressors and bandages to implantable devices (such as pacemakers), diagnostic software, and robotic surgery machines.
These could be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a therapeutic purpose and/or to support a health need - such as rehabilitation equipment.