Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices and other healthcare products, has published a checklist intended to assist medical device manufacturers and other parties involved in conducting a...
Australia and Oceania
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the regulatory requirements related to the cybersecurity aspects associated with medical devices. The document...
Australia and Oceania
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published a consultation paper dedicated to the suggested regulatory approach with regard to the nanomaterials used in medical devices. The document...
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published draft guidance on clinical decision support software. The document describes the changes in the regulatory requirements to be implemented in the course of the upcoming improvement of the existing...
Australia and Oceania
The Malaysian Medical Device Authority (MDA), Malaysia’s agency responsible for regulations in the sphere of healthcare products, has published draft guidance dedicated to the general medical device grouping. The document was published on the official website and made...
