Device Dossier

Cartridge-accepting autoinjector, mechanical

Device Dossier for Cartridge-accepting autoinjector, mechanical (Cartridge-accepting autoinjector, mechanical, Class IIb, sponsor MedVance). ARTG record,…

Intended purpose

A portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient or carer for subcutaneous or intramuscular injection of a dose of the pharmaceutical agent via a replaceable needle. A dial on the injector is operated for dosing (e.g., via a spring-loaded mechanism). This is a reusable device

TGA Public Summary