Australia
The article highlights the critical points of the new classification approach to spinal implantable medical devices.
Australia
The article highlights the key points related to the regulatory status of boundary products in Australia.
Australia
The article highlights the aspects related to the inclusion of new products in the Australian Register of Therapeutic Goods (ARTG), a country’s register of healthcare products allowed for marketing and use in the country.
Australia
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the use of market authorization evidence from comparable overseas regulators/assessment bodies for medical devices (including in vitro diagnostic ones) for abridgement of TGA conformity assessments and as information required for applications for inclusion in the Australian Register of Therapeutic Goods (ARTG).
Australia and Oceania
The article provides an overview of the current regulatory framework for the re-registration of medical devices in Malaysia and describes in detail the most important aspects to be considered when submitting a respective application. The Medical Device Authority...
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