Regulation of medical devices
Regulation of medical devices - Vinyl Council Australia
| As well as a manufacturer’s stringent testing, the fabrication, use and disposal of all medical devices is monitored by regulatory bodies throughout the world. Australian regulations concerning the fabrication and operation of medical devices are overseen by the Therapeutic Goods Administration (TGA), which is administered by the Department of Health and Ageing. View more about TGA and medical devices: Regulation of Medical Devices |
| A second Federal regulatory body is reviewing the safety of 24 phthalates in sensitive end uses such as medical devices and toys. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) has released its 2008 Phthalates Hazard Compendium. |
| NICNAS is expected to release risk assessments for the most common phthalates used in 2009. |
| World-wide, the healthcare sector wants to make sure the best products are used to advance patient care. Innovation in the sector aims to advance patient care but it has the same imperative as traditional product development – the chemicals and materials, production techniques and end-of-life management of new products must be at the same high levels of safety as those used for existing products. For many applications DEHP and non-DEHP plasticised PVC continues to be the preferred material to deliver high quality, effective and affordable healthcare. Approved by regulatory authorities, PVC medical devices continue to be used around the world to advance healthcare and save lives. |
